Active Studies
The Premier Research Department supports cutting-edge research in Pulmonary Related Diseases and Medicine, offering numorious studies for Asthma, COPD, IPF, PAH and many more at dedicated research centers. Several research groups report directly to the Principle Investigator (PI), Dr. Sanober Kable, most research studies are based in individual clinical settings, where they engage in interdisciplinary research that complements the academic goals of their departments.
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PRESTO - COPD
Description: A Multicentre, Parallel-group, Phase IIb, Randomised, Double-blind, Placebo-controlled, 4-Arm, 24-Week Study to Evaluate the Effi cacy and Safety of AZD6793 Tablets in Adult Participants with Moderate to Very Severe Chronic Obstructive Pulmonary Disease
Medication: AZD6793 or Placebo
Duration: 24 Weeks
Dose: Once Daily (QD)
Phase: 2b
Clinicaltrial.gov ID: NCT07082738
- Participant must be ≥40 years of age at the time of signing the informed consent.
- Documented primary diagnosis of moderate to very severe COPD for at least 12 months prior to enrolment.
- Pre-BD FEV1/FVC < 0.7 at Visit 1 and pre- and post-BD FEV1/FVC < 0.7, and post-BD FEV1 ≥ 25% to < 80% of predicted normal at Visit 2.
- Documented history of ≥ 2 moderate or ≥ 1 severe COPD exacerbations in the 12months prior to screening.
- Documented stable regimen of inhaled triple maintenance therapy or inhaled dual maintenance therapy for ≥ 3 months prior to screening.
- CAT score ≥ 10 at Visit 1.
- Current or ex-smokers with a cigarette smoking history of ≥ 10 pack-years.
- Participants who are clinically stable and free from an exacerbation of COPD for 4 weeks prior to Visit 1 and remain exacerbation free at Visit 3 (randomisation).
- Negative pregnancy test at Visit 1 and Visit 3 for Women Of Child-Bearing Potential (WOCBP).
- Clinically important pulmonary disease other than COPD (eg, asthma [current diagnosis per GINA or other accepted guidelines], active pulmonary infection, clinically signifi cant bronchiectasis when bronchiectasis is the predominant diagnosis, pulmonary fi brosis, cystic fi brosis, hypoventilation syndrome associated with obesity, lung cancer, alpha-1 antitrypsin defi ciency or primary ciliary dyskinesia).
- Radiological fi ndings suggestive of a respiratory disease other than COPD that is signifi cantly contributing to the participant's respiratory symptoms.
- Any unstable disorder, including, but not limited to, CV, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, haematological, psychiatric disorder, major physical and/or cognitive impairment.
- Signifi cant left heart failure.
- Unstable angina, acute coronary syndrome/acute myocardial infarction or coronary intervention with percutaneous coronary intervention/coronary artery bypass graft within 6 months of randomisation, uncontrolled arrhythmia, or cardiomyopathy, clinically signifi cant aortic stenosis, or signs of pulmonary oedema or volume overload.
- Pulmonary arterial hypertension, either idiopathic or due to connective tissue or thromboembolic disease.
- History of another underlying condition that predisposes the participant to infections.
- History of ulcerative colitis, Crohn's disease, or microscopic colitis diagnosed by either a gastroenterologist or by histopathology.
- Abnormal laboratory fi ndings.
- Participants with evidence of active liver disease and/or evidence of chronic liver disease.
- Participants with a history of HIV infection or who test positive for HIV.
- History of lung volume reduction surgery.
- Current or history of malignancy within 5 years before the screening visit.
RENEW - COPD
Description: A Phase 2, Multicenter, Randomized, Double-Blind, 52-week Study to Investigate the Effi cacy and Safety of Brenipatide Compared with Placebo for the Treatment of Adult Participants with Moderate-to-Severe Chronic Obstructive Pulmonary Disease
Medication: Brenipatide (LY3537031) or Placebo
Duration: 52 Weeks
Dose: Once Weekly (QW)
Phase: 2
- Are 40 to 75 years of age inclusive, at the time of signing the informed consent.
- Have a physician diagnosis of COPD
- Have a chest X-ray or chest CT scan within 12 months prior to screening
- Meet all the following criteria at Visit 3 prior to randomization
- Have a BMI of ≥25.0 kg/m2 at Visit 1 (screening) and Visit 3 (randomization).
- Participants must demonstrate compliance with background therapy
- Have a known pre-existing, clinically important lung condition other than COPD, including but not limited to:
- chronic respiratory infection
- diagnosis of asthma or childhood asthma
- signifi cant bronchiectasis (that is, CT evidence of bronchiectasis that causes repeated acute exacerbations)
- pulmonary fi brosis
- history of or planned pneumonectomy or lung volume reduction procedures
- allergic bronchopulmonary aspergillosis
- diagnosis of known α-1 anti-trypsin defi ciency
- Have had a moderate or severe COPD exacerbation within the 30 days prior to Visit 1 (screening) or during the screening/lead-in period.
- Require supplemental oxygen >2 LPM at rest for greater than 8 hours.
- Have a prior diagnosis of:
- type 1 diabetes mellitus or a history of ketoacidosis, or hyperosmolar state or coma
- rare forms of diabetes mellitus, except gestational diabetes.
- Have no prior medical history of diabetes
- Have, in the opinion of the investigator, evidence of signifi cant, uncontrolled endocrine abnormality, for example, hypothyroidism, thyrotoxicosis, or adrenal crisis.
- Have a current or recent acute, active infection. For at least 30 days before screening (Visit 1) and up to the randomization visit (Visit 3), participants must have no symptoms or signs of confi rmed or suspected infection and must have completed any appropriate anti-infective treatment.
- Have active TB
- Have or have had LTBI that has not been treated with a complete course of appropriate therapy
- Have a current infection with hepatitis B virus (HBV), that is, positive for hepatitis B surface antigen (HBsAg).
- Have a current infection with hepatitis C virus (HCV) that is, positive for HCV RNA
- Have human immunodefi ciency virus infection
- Have renal impairment measured as estimated glomerular fi ltration rate <30 mL/min/1.73 m2, calculated by Chronic Kidney Disease Epidemiology Collaboration Cystatin-C equation (2012)
- Have creatinine ≥2 mg/dL (≥176.8 μmol/L) at Visit 1 (screening)
- Have a known clinically signifi cant gastric emptying abnormality, such as severe diabetic gastroparesis or gastric outlet obstruction, or in the opinion of the investigator, have clinically signifi cant GI motility changes related to their current medication regimen.
- Have undergone or plan to have during the study either gastric bypass (bariatric) surgery or restrictive bariatric surgery, for example, LAP-BAND
- Have a diagnosis of a condition of micro- or macronutrient malabsorption (for example,Crohn’s disease, celiac disease, small intestine resection) that is of signifi cant clinical concern in the opinion of the investigator.
- Have a history of acute or chronic pancreatitis
- Have a self-reported or documented reduction in body weight ≥5% within 90 days before screening (Visit 1)
- Have a lifetime history or current diagnosis of the following:
- borderline personality disorder
- any eating disorder
- in the investigator’s assessment, have any signifi cant mental health disorder that may put the individual at higher risk from study participation.
- Are, in the judgment of the investigator, actively suicidal, and therefore, deemed to be at a signifi cant risk for suicide or have a history of suicide attempt within the past 1 year.
- Have had within the past 180 days before screening (Visit 1)
- acute myocardial infarction
- cerebrovascular accident (stroke)
- hospitalization for unstable angina
- hospitalization due to congestive heart failure
- Have a 12-lead ECG abnormality at screening (Visit 1) or randomization (Visit 3) that, in the opinion of the investigator, increases the risks associated with participating in the study or may confound ECG data analysis.
- Have a history of New York Heart Association Functional Classifi cation Class IV congestive heart failure
- Have any hematological condition that may interfere with HbA1c measurement, for example, hemolytic anemias or hemoglobin ≤8.0 g/dL
- Have a diagnosis or history of malignant disease within 5 years before screening (Visit 1), with the following exceptions:
- basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years
- cervical carcinoma in situ with no evidence of recurrence within 5 years prior to baseline, or
- Grade 1 (for example, Gleason 6 or lower) prostate cancer.
- Have acute or chronic hepatitis, including a history of autoimmune hepatitis, signs, or symptoms of any other liver disease other than metabolic dysfunction-associated steatotic liver disease (MASLD), or any of these laboratory values during screening (Visit 1)
- Have had a transplanted organ or are awaiting an organ transplant, with the exception of corneal transplants or keratoplasty.
- At the time of screening have a planned surgery, except for minor surgical procedures, to occur during the study.
- Have a Vitamin B1 (thiamine) or Vitamin B9 (folate) defi ciency that is severe or of signifi cant clinical concern in the opinion of the investigator at screening (Visit 1).
- Have a history of symptomatic gallbladder disease within the past 2 years, defi ned by the presence of gallstones on an imaging study and abdominal pain attributed to the gallstones by the participant’s physician.
- Within 30 days before screening (Visit 2), have used any of the following medications:
- PDE4 inhibitors (rofl umilast/ensifentrine)
- macrolide antibiotics
- beta-adrenergic receptor blockers.
- Have received any immunoglobulin or blood products within the 30 days prior to Visit 3.
- Have received any live vaccine (that is, live attenuated), except FluMist®, within less than 30 days before randomization (Visit 3), or intend to receive a live vaccine during the study, or within 45 days or 5 half-lives, whichever is earlier, after receiving the last dose of study intervention.
- Have received a BCG vaccination or treatment within less than 30 days before randomization (Visit 3) or intend to receive BCG vaccination or treatment during the study, or within 45 days or 5 half-lives, whichever is earlier, after receiving the last dose of study intervention.
- Within 90 days before Visit 2, have taken a medication with GLP-1 RA activity (examples include, but are not limited to, liraglutide, semaglutide, and tirzepatide).
- Within 90 days before Visit 2 or between Visit 2 and randomization (Visit 3), have taken any of the following medications:
- DPP-4 inhibitors
- amylin analogues
- incretins, including but not limited to medications with GLP1 RA activity insulin, or
- sulfonylureas.
- Within 90 days received other prescribed or over-the-counter medications, compounded or alternative remedies,including herbal or nutritional supplements, intended to promote body weight reduction.
- Have used systemic immunomodulators or immunosuppressive medication
- Have received a biologic treatment for COPD
- Have any condition that is a contraindication to GLP-1 RAs
- Have participated in a clinical study and received active treatment, or unknown if they received active treatment, within 90 days
- Are currently enrolled in any other clinical study involving an investigational product or any other type of medical research judged not to be scientifi cally or medically compatible with this study.
- Have previously completed or withdrawn from this study or any other study investigating brenipatide after receiving at least 1 dose of active or unknown study intervention.
- Have had any of the following procedures:
- blood donation of >500 mL within 8 weeks prior to Visit 3
- blood transfusion or severe blood loss within the prior 3 months.
- are pregnant or breastfeeding or intending to become pregnant or breastfeed
- Are investigator site staff directly affi liated with this study and their immediate family
- Are Lilly employees or are employees of any third party involved in the study who require exclusion of their employees
- Have any condition, unwillingness, or inability, not covered by any of the other exclusion criteria, which in the investigator’s opinion, might jeopardize the participant’s safety, for example, acute, serious, or unstable medical condition, hypersensitivity, contraindication, or compliance with the protocol.
THESEUS - COPD
Description: A Phase 2b/Phase 3, randomized, double-blind, placebo-controlled, multicenter study, to investigate the effi cacy and safety of lunsekimig in adult participants with inadequately controlled chronic obstructive pulmonary disease (COPD) characterized by an eosinophilic phenotypePulmonary Disease
Medication: Lunsekimig or Placebo
Duration: 48 Weeks
Dose: Monthly Injection
Phase: 2b/3
Clinicaltrial.gov ID: NCT07190222
- Participants who completed the 48-week treatment period of Study DRI16762 or ACT18301, including the EOT visit, as per protocol
- Participants with stable background therapy with moderate or high-dose ICS in combination with the following controller medications, as maintained during the respective parent study in which they have participated:
- For Study DRI16762: At least 1 and no more than 2 additional controllers (eg, LABA, LAMA, LTRA, or methylxanthines) with or without oral prednisone
- For Study ACT18301: LABA with or without LTRA
- Participants who are able and willing to participate in the open-label extension study, and to comply with requested study visits and procedures
- Contraception for male and female participants For female participants:
- must agree to use contraception/barrier
- not pregnant or breast feeding
- no eggs donation or cryopreserving eggs
- For male participants: No sperm donation or cryopreserving sperm
- Capable of giving signed informed consent
- Participant who developed a new medical condition or a change in status of an established medical condition or requires a new treatment or medication prior to enrollment that, per Investigator's medical judgement would adversely affect participation of the participant in this study or would require permanent lunsekimig discontinuation, or participants potentially at risk of noncompliance to study procedures
- Participant who was diagnosed with a new pulmonary disease which may impair lung function
- Current smoker or active vaping of any products and/or marijuana smoking
- Prescription drug or substance abuse, including alcohol, considered signifi cant by the Investigator
- History of hypersensitivity or allergy to lunsekimig or to any of the excipients used in the presentation or in preparation for administration of lunsekimig, or other allergy that, in the opinion of the Investigator, contraindicates participation in the study
- Participants who are receiving prohibited concomitant medications
- Participants who, during their participation in the parent study, developed an AE or an SAE deemed related to lunsekimig, which in the opinion of the Investigator could indicate that continued treatment with lunsekimig may present an unreasonable risk for the participant
- Concurrent participation in any other clinical study, including non-interventional studies
- Individuals accommodated in an institution because of regulatory or legal order; prisoners or participants who are legally institutionalized
- Participants are employees of the investigative site or other individuals directly involved in the conduct of the study, or immediate family members of such individuals.
SURPASS - IPF
Description: A Randomized, Double-Blind, Head-to-Head Phase 3 Trial to Evaluate the Effi cacy and Safety of LYT-100 (Deupirfenidone) Compared to Pirfenidone at 52 Weeks in Adults With Idiopathic Pulmonary Fibrosis
Medication: Deupirfenidone or Pirfenidone
Duration: 52 Weeks
Dose: Three Capsules per Day (TID)
Phase: 3
Clinicaltrial.gov ID: NCT07284602
- Is ≥40 years of age at the time of informed consent.
- Meets the diagnostic criteria of IPF American Thoracic Society (ATS)/European Respiratory Society (ERS)/Japanese Respiratory Society (JRS)/Latin American Thoracic Society (ALAT) 2022 guidelines.
- Has a maximum time from initial IPF diagnosis of 7 years.
- Has no prior exposure to pirfenidone or LYT-100, and has <12 months of prior exposure to nintedanib or any other approved antifi brotic therapies.
- Has defi nite or probable unusual interstitial pneumonia (UIP) on HRCT, performed within 12 months prior to Visit 1 and confi rmed by the central reader.
- Has an FVC ≥45% of predicted normal at Visit 1.
- Has, in the opinion of the Investigator, signifi cant clinical worsening of IPF between Visit 1 and Visit 2.
- Has been hospitalized within 3 months prior to Visit 1 for acute exacerbation of IPF or other signifi cant respiratory complication.
- Has prebronchodilator forced expiratory volume in 1 second (FEV1)/FVC <0.7 at Visit 1.
- Has a greater extent of emphysema vs fi brosis on the most recent HRCT scan as confi rmed by the central reader.
- Has a diagnosis of any condition that could be an explanation for interstitial lung disease (ILD).
- Has a major extrapulmonary condition that could affect spirometry.
- Has a current diagnosis of other relevant respiratory disorders.
- Has signifi cant pulmonary hypertension (PH).
- Has had a lung transplant.
- Has cardiovascular disease.
- Has underlying chronic liver disease/impairment.
- Has relevant chronic or acute infections including active viral hepatitis or poorly controlled HIV.
- Has had any major surgical procedures performed within 6 weeks prior to Visit 1 or is planning to have a major surgical procedure during the study.
- Has any documented active or suspected malignancy or history of malignancy within 5 years prior to Visit 1.
- Has any of the following laboratory abnormalities at Visit 1:
- Aspartate aminotransferase (AST) or Alanine aminotransferase (ALT) >1.5 × upper limit of normal (ULN).
- Total bilirubin >1.5 × ULN. Exceptions may be made on a case-by-case basis for participants with Gilbert's syndrome in consultation with the Medical Monitor.
- Creatinine clearance <30 mL/min calculated by Cockcroft-Gault formula.
- Is currently taking prednisone at a steady dose >10 mg/day or equivalent (a steady dose ≤10 mg/day is not exclusionary but the individual must be on a stable dose for at least 30 days prior to Visit 2).
- Use of any tobacco or combustible cannabis products within 3 months prior to Visit 1 or is unable to refrain from use during the trial.
- Has known symptoms of dysphagia, diffi culty in swallowing capsules or tablets, or has had a total gastrectomy.
- Is currently enrolled in another clinical study (except observational/registry or biobank studies) or has used any investigational drug or device within 90 days prior to Visit 1.
- Has ever received stem cell therapy for the treatment of pulmonary fi brosis.
- Is currently pregnant, breastfeeding, or is planning to become pregnant during the study.
- Has had any prior exposure to LYT-100 or pirfenidone (even one dose).
Fighting Fibrosis - IPF
Description: A Randomized, Double-Blind, Placebo-Controlled Phase II Study to Determine the Safety and Effi cacy of Oral Ifetroban in Patients with Idiopathic Pulmonary Fibrosis
Medication: Ifetroban or Placebo
Duration: 52 Weeks
Dose: 5 Capsules Daily
Phase: 2b
Clinicaltrial.gov ID: NCT05571059
- Patient 40 Years or Older at the time of signed informed consent
- IPF diagnosis:
- Satisfying the 2022 American Thoracic Society/European Respiratory Society/Japanese Respiratory Society/ Latin American Thoracic Association(ATS/ERS/JRS/ALAT) diagnostic criteria (Raghu 2022) confi rmed by the investigator
- UIP or probable UIP based on chest HRCT obtained within 12 months of Day 0, or historical lung biopsy consistent with UIP
- If receiving antifi brotic agents pirfenidone or nintedanib, patients must be receiving a stable dose for > 2 months prior to Day 0 and planning to stay on stable background therapy; if not receiving pirfenidone or nintedanib, patients must be naive to both drugs or not have received either for at least four weeks prior to Day 0 and remain off background therapy with no intention to start or re-start. (combination of nintedanib and pirfenidone not allowed)
- If receiving monotherapy for the treatment of pulmonary hypertension (eg, phosphodiesterase 5 inhibitors, endothelin receptor antagonists, or inhaled or oral prostanoid therapy), patients must be receiving a stable dose for > 4 weeks prior to Day 0 and planning to remain on a stable dose throughout the study
- FVC > 40% of predicted normal according to Global Lung Initiative
- DLCO (corrected for hemoglobin) > 25% to <80% of predicted normal
- ACQ-5 score ≥1.5 at screening (visit 1)
- Relevant airways obstruction (pre-bronchodilator Forced Expiratory Volume in one second to forced vital capacity ratio less than 70%[FEV1/FVC <0.7])
- Known signifi cant PAH, defi ned as previous clinical or echocardiographic evidence of signifi cant right heart failure, history of right heart catheterization showing a cardiac index >2 L/min/m, or PAH requiring combination of PAH-specifi c therapies or any PAH parenteral therapy.
- Emphysema > 50% on HRCT assessed by the investigator, or the extent of emphysema is greater than the extent of fi brosis according to reported results from the most recent chest HRCT.
- Acute IPF exacerbation within six weeks prior to screening and/or during the screening period (investigator-determined).
- Lower respiratory tract infection requiring antibiotics within four weeks prior to Day 0 and/or during the screening period.
- Major surgery (major according to the investigator’s assessment) performed within six weeks prior to Day 0 or planned during the course of the trial. (Being on a transplant list is allowed).
- Underlying chronic liver disease (Child Pugh A, B, or C hepatic impairment).
- Cardiovascular diseases, and of the following:
- Severe hypertension, uncontrolled despite treatment (>160/100 mmHg)
- Myocardial infarction within six months of Day 0
- Unstable cardiac angina
- Bleeding risk, any of the following:
- Known genetic predisposition to bleeding
- Patients who require:
- Fibrinolysis, full-dose therapeutic anticoagulation
- High dose antiplatelet therapy
- Use of systemic corticosteroids equivalent to prednisone > 15mg/day within two weeks of Day 0
- Any documented active or suspected malignancy or history of malignancy within fi ve years prior to Day 0, except appropriately treated basal cell carcinoma of the skin, in situ squamous cell carcinoma of the skin, in situ carcinoma of uterine cervix or “under surveillance” prostate cancer.
- Evidence of active infection based on clinical exam or laboratory findings
Zapphire - IPF
Description: A Randomized, Double-Blind, Placebo-Controlled Phase II Study to Determine the Safety and Effi cacy of Zampilimab in Patients with Idiopathic Pulmonary Fibrosis
Medication: Zampilimab or Placebo
Duration: 24 Weeks
Dose: IV Infusion Monthly
Phase: 2
Clinicaltrial.gov ID: NCT07516951
- Informed consent: Participant's written informed consent obtained prior to any study-related procedure.
- Sex and age: Male or female, of any race and ethnicity, aged ≥40 years with a life expectancy of at least 1 year at screening in the opinion of the Investigator.
- Body weight ≥45 kg.
- Diagnosis of IPF: Diagnosis as defi ned by the 2018 and 2022 American Thoracic Society/European Respiratory Society/Japanese Respiratory Society/Latin American Thoracic Society Guidelines for a maximum 8 years before screening. The most recent HRCT(High-resolution computed tomography) ≤6 months prior to screening, reviewed by central reading, should be used to confi rm the diagnosis.
- Lung function: Forced vital capacity (FVC) ≥45% of predicted normal value and a ratio of forced expiratory volume in the fi rst second/FVC ≥0.7 at screening.
- Diffusing capacity of the lung for carbon monoxide (DLCO) corrected for haemoglobin ≥25% of predicted normal at screening.
- Oxygen saturation measured by pulse oximetry (peripheral capillary oxygen saturation [SpO2]) >90% at rest when the maximum oxygen fl ow is 4 L/min by standard nasal cannula or the equivalent oxygen delivery via reservoir nasal cannula (≤2 L/min).
- Participant with a documented diagnosis of coeliac disease.
- Low respiratory tract infection: Documented low respiratory tract infection in the last 4 weeks prior to screening or documented acute exacerbation of IPF (defi ned as acute worsening or development of dyspnoea typically <1 month duration;
- Lung cancer: Active diagnosis or history of lung cancer.
- Emphysema: HRCT (refer to inclusion criterion #5 [Diagnosis of IPF]), reviewed by central reading, shows the presence of emphysema ≥20% or that the extent of emphysema is greater than the extent of fi brosis.
- Organ transplantation: End-stage fi brotic disease expected to require organ transplantation within 6 months from screening.
- Other medical conditions: Clinically relevant and uncontrolled pulmonary (including any non-IPF pulmonary diagnosis), cardiac, hepatic, gastrointestinal, renal, endocrine, metabolic, neurologic, psychiatric disorders, active or untreated latent tuberculosis/tuberculosis infection that may interfere with the participant's ability to complete this study according to the Investigator's judgement.
- Any other comorbid non-IPF pulmonary condition that may impact FVC according to the Investigator's judgement. Emphysema is allowed, unless it meets the above exclusion criterion regarding emphysema.
- Participant currently treated, or been treated with cytotoxic and immunosuppressant/modulator drugs within 48 weeks prior to screening. Systemic (IV, intramuscular, or oral) corticosteroids prednisone- equivalent dose of >10 mg/day used for >10 days.
- Hypersensitivity: Known intolerance and/or hypersensitivity to any of the excipients contained in the formulation or any other substance used in the study.
- History of allergic or anaphylactic reaction to human, humanised, chimeric Igs (immunoglobulins), or murine monoclonal antibodies.
BLISSC-ILD
Description: A Phase 2/3, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the effi cacy and safety of belimumab administered subcutaneously in adults with systemic sclerosis associated interstitial lung disease
Medication: Belimumab or Placebo
Duration: 52 Weeks
Dose: Once weekly
Phase: 2
Clinicaltrial.gov ID: NCT05878717
- Participant is 18 years of age inclusive, or older at the time of signing the informed consent.
- Documented diagnosis of SSc as defi ned by the American College of Rheumatology classifi cation criteria
- Diffuse cutaneous disease, defi ned as presence of thickened skin with mRSS >0 over at least one skin area proximal to elbows and/or knees in addition to distal areas involvement on Day 1
- Total mRSS >15 on Day 1
- Evidence of interstitial lung disease on centrally read screening HRCT
- Anticentromere antibodynegative on central test at screening
- Evidence for active or progressive disease, defi ned by at least one of the following criteria
- Disease duration <24 month on Day 1
- Disease duration >24 months but <5 years on Day 1 AND one of the following
- Anti-topoisomerase I antibody positive on central test at screening, OR
- Absolute decline in FVC >5% predicted as determined by a comparison of the screening lung function test and a previous lung function test done within 12 months prior to screening AND worsening respiratory symptoms, OR
- Absolute decline in DLco >10% predicted as determined by a comparison of the screening lung function test and a previous lung function test done within 12 months prior to screening AND worsening respiratory symptoms, OR
- Progressive ILD on HRCT, as assessed by the investigator comparing the screening scan and a previous scan done within 12 months prior to screening.
- Disease duration >5 but <7 years on Day 1 AND anti-topoisomerase I antibody positive on central test at screening, AND one of the following:
- Absolute decline in FVC >5% predicted as determined by a comparison of the screening lung function test and a previous lung function test done within 12 months prior to screening AND worsening respiratory symptoms, OR
- Absolute decline in DLco >10% predicted as determined by a comparison of the screening lung function test and a previous lung function test done within 12 months prior to screening AND worsening respiratory symptoms, OR
- Progressive ILD on HRCT, as assessed by the investigator comparing the screening scan and a previous scan done within 12 months prior to screening.
- Participant has an area of uninvolved or mildly thickened skin that, in the opinion of the investigator, would allow SC injection at the abdomen or the front, middle region of the thigh
- Participant is capable and willing to self-administer the study medication or has a caregiver who is capable and willing to administer the study medication throughout the study
- Female participants eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies:
- Is a WONCBP
- Is a WOCBP and using a contraceptive method that is highly effective, with a failure rate of <1% during the study intervention period and for at least 4 months after the last dose of study intervention.
- A WOCBP must have a negative highly sensitive pregnancy test within 24 hours before the fi rst dose of study interventionIf a urine test cannot be confirmed as negative, a serum pregnancy test is required
- Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in this protocol
- Systemic sclerosis-like illness, including but not limited to localized scleroderma, eosinophilic fasciitis, sclerodermoid graft-versus-host disease, fi bro mucinous conditions, scleroderma-like conditions that are associated with environmental chemical and drug exposure
- Primary diagnosis of a rheumatic autoimmune disease other than dcSSc, including but not limited to rheumatoid arthritis, systemic lupus erythematosus, polymyositis, dermatomyositis, systemic vasculitis, Sjogren’s syndrome, antisynthetase syndrome, or mixed connective tissue disease
- FVC <45% of predicted, or a DLco <40% of predicted or requiring supplemental oxygen at screening
- Pulmonary arterial hypertension prior to fi rst day of dosing
- SSc renal crisis within 6 months prior to the fi rst day of dosing
- History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, or neurological disorders capable of signifi cantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention or interfering with the interpretation of data
- Obstructive pulmonary disease
- Signifi cant emphysema on screening HRCT
- Signifi cant allergies to human or murine proteins, humanized monoclonal antibodies, or contrast agents
- Clinically signifi cant multiple or severe drug allergies, intolerance to topical corticosteroids, or severe post-treatment hypersensitivity reactions
- Lymphoma, leukemia, or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years
- Breast cancer within the past 10 years
- ALT>2 x ULN
- Total bilirubin >1.5 x ULN
- Cirrhosis or current unstable liver or biliary disease per investigator assessment defi ned by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, or persistent jaundice
- QTc >450 msec or QTc >480 msec in participants with bundle branch block
- Major surgery within 3 month prior to screening or planned during the duration of the study
- An active infection, or a history of infections as follows:
- History of opportunistic infections that have not resolved by 6 month prior to the fi rst day of dosing or recurrent infection as determined by the investigator
- A serious infection requiring treatment with IV antibiotics and/or hospitalization, if the last dose of antibiotics or the hospital discharge date was within 60 days of the fi rst day of dosing
- An acute or chronic infection requiring treatment with oral antibiotics or antiviral medications, if the last doe was received within 30 days of the fi rst day of dosing. Prophylactic anti-infective treatment is allowed
- Any active or unresolved bacterial, viral or fungal infection present on the fi rst day of dosing, whether requiring treatment or not. This does not include fungal nail infections
- Active or past osteomyelitis, unless fully resolved in the opinion of the investigator
- Symptomatic herpes zoster within 3 month prior to screening
- Evidence of active or latent TB as documented by medical history and examination, chest X-rays, and TB testing: either a positive TST or a positive TB test such as QuantiFERON-TB Gold Plus test
- Confi rmed PML or unexplained new-onset or deteriorating neurologic signs and symptoms
- Have evidence of serious current suicide risk, defi ned as PHQ-9 score >10, or any history of suicidal behavior in the last 6 months and/or any suicidal ideation in the last 2 months or who in the investigator’s judgment, poses a signifi cant suicide risk
- Previous or planned major organ transplant or bone marrow transplant
- Treatment with biologic agents, such as intravenous immunoglobulin or monoclonal antibodies, including marketed drugs, within 3 month or 5 half-lives (whichever is longer) prior to dosing
- Treatment with rituximab within 6 months prior to Day 1
- Treatment with non-biologic systemic immunosuppressive medication, other than mycophenolate, methotrexate or azathioprine within 3 months prior to Day 1
- Treatment with cyclophosphamide within 6 months prior to Day 1
- Use of anti-fi brotic agents including colchicine, D-penicillamine, pirfenidone or tyrosine kinase inhibitors within 4 weeks prior to Day 1
- Cytotoxic drugs such as, chlorambucil, nitrogen mustard, or other alkylating agents within 6 months of Day 1
- Treatment with IM or IV corticosteroids within 1 month prior to Day 1
