A Study of Nemolizumab for the Treatment of Adults With Systemic Sclerosis (NCT07047690) | Clinical Trial Compass
RecruitingPhase 2
A Study of Nemolizumab for the Treatment of Adults With Systemic Sclerosis
United States, Switzerland162 participantsStarted 2026-02-20
Plain-language summary
The main purpose of the study is to investigate the efficacy on cutaneous thickness and the safety of Nemolizumab in adult patients with systemic sclerosis after a 52-week treatment period and to select the optimal dose for this target population.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Participant must be 18 years of age or older, at the time of signing the Informed Consent Form.
✓. Classification of systemic sclerosis (SSc) as defined by the 2013 American College of Rheumatology \[ACR\]/European League Against Rheumatism \[EULAR\] criteria.
✓. Modified Rodnan Skin Score.
✓. Diffuse cutaneous systemic sclerosis (DcSSc) participants and modified Rodnan Skin Score (mRSS) of greater than equal to (\>=)12 and less than (\<)30 at both screening and baseline
✓. Limited cutaneous systemic sclerosis (LcSSc) participants with mRSS \>=8 at both screening and baseline. LcSSc participants with positive anti-centromere at screening are excluded.
✓. Disease duration in DcSSc participants \<= 5 years from screening and LcSSc participants \<=2 years from screening is defined as the time from the first non-Raynaud's phenomenon manifestation of SSc.
✓. Participants are permitted to receive the following background therapies stable for at least 3 months prior to baseline, including any combination of the following:
✓. Nintedanib (\<150mg twice daily) and/or
Exclusion criteria
✕. Anti-centromere antibody positive at screening for participants with LcSSc.
✕. Anti-RNA polymerase 3 antibody positive for participants with a disease duration \>18months.
✕
What they're measuring
1
Change From Baseline (BL) in Modified Rodnan Skin Score (mRSS) at Week 52
. Creatinine clearance \<30 milli liter per minute \[ml/min\] (calculated by Cockcroft-Gault formula).
✕. Positive serology results (hepatitis B surface antigen \[HBsAg\] or hepatitis B core antibody \[HbcAb\], hepatitis C \[HCV\] antibody with positive confirmatory test for hepatitis C virus \[HCV\] antibody with positive HCV RNA, or human immunodeficiency virus \[HIV\] antibody).
✕. FVC \<50% of predicted normal value, and DLCO \<40% of predicted normal value (corrected for Hb) at screening and baseline.
✕. Known diagnosis of clinically significant respiratory disorders other than ILD, including severe chronic obstructive pulmonary disease, severe asthma, recent (within 3 months) severe respiratory infections or history of recurrent respiratory infections, smoking, and any other respiratory condition that, in the opinion of the investigator, could interfere with the study or pose a risk to the participant.
✕. Currently listed and/or anticipated to be listed for lung transplantation within the next 12 months.
✕. Cardiovascular disease with clinically significant arrhythmia requiring therapy, congestive heart failure (New York Heart Association Class III-IV functional capacity), unstable angina, uncontrolled hypertension, Cor pulmonale, or symptomatic pericardial effusion.