Platform Clinical Study to Evaluate the Safety and Efficacy of Investigational Products in Participants with Interstitial Lung Disease Secondary to Systemic Sclerosis

JRCT ID: jRCT2031240052

Registered date:25/04/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Patients with interstitial lung disease (ILD) secondary to systemic sclerosis (SSc) (SSc-ILD)
• Date of first enrollment: 01/07/2024
• Target sample size: 19
• Countries of recruitment: United States,Japan,United Kingdom,Japan,Thailand,Japan,Taiwan,Japan,Spain,Japan,South Korea,Japan,Portugal,Japan,Poland,Japan,Norway,Japan,Netherlands,Japan,Mexico,Japan,Malaysia,Japan,Italy,Japan,Israel,Japan,India,Japan,Germany,Japan,France,Japan,Denmark,Japan,China,Japan,Chile,Japan,Belgium,Japan,Austria,Japan,Australia,Japan,Argentina,Japan
• Study type: Interventional

Intervention(s)

There will be multiple interventional regimens, each consisting of the study participants receiving either the active IP or its matching placebo.

Amlitelimab or matching Placebo:
will be administrated with a loading dose of 500 mg on Day 1, and will be administrated one dose level of 250 mg SC every 4 weeks (Q4W) after Day 1.

BI 1015550 or Placebo:
One 18 mg tablet of BI 1015550 or Placebo is orally administered BID

Outcome(s)

• Primary Outcome: To evaluate the efficacy of the investigational products (IPs) compared with placebo on the change from baseline to the end of the treatment period at Week 52 in forced vital capacity (mL), measured in study participants with SSc-ILD.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. Male or female at least 18 years of age at the time of signed informed consent;
2. SSc classification as defined by the 2013 American College of Rheumatology/European League Against Rheumatism criteria. An enrollment cap will apply to the limited/sine cutaneous SSc subtype. The enrollment cap will allow for equal or less than 30% of limited/sine cutaneous SSc subtype study participants for each Regimen-specific Subprotocol (IP);
3. Onset of SSc (defined by first non-Raynaud's symptom) 5 years or less prior to the Screening Visit;
4. Modified Rodnan skin score (mRSS) of 10 to 35, inclusive, in participants with diffuse cutaneous SSc;
5. Presence of ILD with evidence of any fibrosis on HRCT (within 3 months or less of randomization)
6. Presence of an FVC 45% or more predicted normal;
7. Presence of a diffusing capacity of the lung for carbon monoxide (DLCO) 30% or more predicted normal, corrected for hemoglobin;

Other master protocol and/or subprotocol inclusion criteria apply.

Exclude criteria

1. Presence of clinically significant pulmonary abnormalities inconsistent with ILD on HRCT (e.g., scarring due to previous active tuberculosis (TB), sarcoidosis, lung mass, or otherfindings unrelated to SSc-ILD, as determined by a local radiologist/Investigator)
2. History of stem cell transplantation, bone marrow transplantation, chimeric antigen receptor T-cell therapy, or solid organ transplantation
3. Women who are pregnant, nursing, or who plan to become pregnant while in the clinical study
4. History of Child-Pugh Class B or Class C liver disease
5. Presence of any of the following laboratory findings at the Screening Visit:
- Estimated glomerular filtration rate less than 45 mL/min/1.73 m2, calculated using the Chronic Kidney Disease Epidemiology Collaboration equation
- Alanine aminotransferase or aspartate aminotransferase level over 1.5 x upper limit of normal (ULN)
- Platelets less than 100 x 109/L (100,000/microliter)
- White blood cell count less than 2500/microliter
- Neutrophil blood count less than 1500/microliter
- Prolongation of prothrombin time and partial thromboplastin time less than 1.5 x ULN, or international normalized ratio less than 2 or
- Any other laboratory test result, that in the opinion of the Investigator, might place the study participant at risk for participation in the study.
6. History of major trauma or hemorrhage within 30 days of the Screening Visit
7. History of any clinically significant chronic intermittent bleeding, such as active gastric antral vascular ectasia or active peptic ulcer disease, within 60 days of the Screening Visit
8. Presence of other clinically significant risk of bleeding events, including coagulation or platelet disorders, at the Screening Visit as determined by the Investigator
9. History of any cerebrovascular events (e.g., transient ischemic attack or stroke) within 6 months of the Screening Visit
10. History of myocardial infarction or unstable angina within 6 months of the Screening Visit, or plans to undergo a coronary procedure during participation in the study
11. Presence of acute or chronic congestive heart failure (New York Heart Association Class III (moderate) or Class IV (severe)) at the Screening Visit
Other master protocol and/or subprotocol exclusion criteria apply.

Related Information

• Primary Sponsor: Kay Richard
• Secondary ID(s): NCT06195072