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A Study of Nemolizumab for the Treatment of Adults With Systemic Sclerosis | Clinical Trials | Clareo Health

NOT_YET_RECRUITINGPHASE2

A Study of Nemolizumab for the Treatment of Adults With Systemic Sclerosis

A 52-week, Multicenter, Randomized, Double-blind, Placebo-controlled, Dose-ranging Study of Nemolizumab in Adult Patients With Systemic Sclerosis

NCT07047690•Galderma R&D

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Participant must be 18 years of age or older, at the time of signing the Informed Consent Form.
•2. Classification of systemic sclerosis (SSc) as defined by the 2013 American College of Rheumatology \[ACR\]/European League Against Rheumatism \[EULAR\] criteria.
•3. Modified Rodnan Skin Score.
•1. 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
•2. Limited cutaneous systemic sclerosis (LcSSc) participants with mRSS \>=8 at both screening and baseline. LcSSc participants with positive anti-centromere at screening are excluded.
•4. 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.
•5. Participants are permitted to receive the following background therapies stable for at least 3 months prior to baseline, including any combination of the following:
•1. Nintedanib (\<150mg twice daily) and/or
•2. One of the following:
•1. Methotrexate (MTX) (\<25mg weekly) or
+5 more criteria

Exclusion Criteria

•1. Anti-centromere antibody positive at screening for participants with LcSSc.
•2. Anti-RNA polymerase 3 antibody positive for participants with a disease duration \>18months.
•3. Creatinine clearance \<30 milli liter per minute \[ml/min\] (calculated by Cockcroft-Gault formula).
•4. 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).
•5. FVC \<50% of predicted normal value, and DLCO \<40% of predicted normal value (corrected for Hb) at screening and baseline.
•6. 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.
•7. Currently listed and/or anticipated to be listed for lung transplantation within the next 12 months.
•8. 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.
•9. History of myocardial infarction in the last 6 months prior to screening.
•10. Pulmonary hypertension WHO Functional Class III or higher (as defined by WHO 2009) requiring treatment.
+16 more criteria

Key Dates

Start Date

December 15, 2025

Primary Completion Date

May 28, 2028

Completion Date

July 23, 2028

Last Updated

December 17, 2025

Enrollment

162

ESTIMATED participants

Conditions

Systemic Sclerosis

Interventions

Nemolizumab

DRUG

Placebo

DRUG

Contacts

Galderma Research and Development

CONTACT

817-961-5000 clinical.studies@galderma.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 17, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

A Study of Nemolizumab for the Treatment of Adults With Systemic Sclerosis

Inclusion Criteria

Exclusion Criteria

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