Platform Clinical Study for Conquering Scleroderma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorScleroderma Research Foundation, Inc.
About this trial
The goal of this clinical trial is to test efficacy of different investigational products (IPs) compared with placebo on the change from baseline to the end of the treatment period at Week 52 in lung capacity in participants with Interstitial Lung Disease Secondary to Systemic Sclerosis.
Eligibility criteria
Qualifiers
Male or female 18+ years of age at the time of signed informed consent;
SSc classification as defined by the 2013 American College of Rheumatology/European League Against Rheumatism criteria. Participants with diffuse, limited or sine cutaneous skin involvement are eligible
Onset of SSc (defined by first non-Raynaud's symptom) 7 years or less prior to the Screening Visit;
A Modified Rodnan skin score (mRSS) less than 40
Disqualifiers
Presence of clinically significant pulmonary abnormalities inconsistent with ILD on HRCT (e.g., scarring due to previous active tuberculosis [TB], sarcoidosis, lung mass, or other findings unrelated to SSc-ILD, as determined by a local radiologist/Investigator);
Presence of infected ulcers or active gangrene at the Screening Visit;
History of scleroderma renal crisis within 6 months prior to the Screening Visit;
Forced expiratory volume in 1 second/FVC <0.65 (pre-bronchodilator) at the Screening Visit
Trial design
Treatments tested in this trial
- Amlitelimab
- BI 1015550 (Nerandomilast)
- Placebo
Treatment groups
400 Participants
are divided into 4 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov