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

NCT07047690 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: SPR207796
• Study Type: interventional
• Target: 162
• Locations: 2 countries
• Sites: 3

Brief 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.

Conditions

Systemic Sclerosis

Keywords

Limited Cutaneous Systemic Sclerosis; Diffuse Cutaneous Systemic Sclerosis; Interstitial Lung Disease

Outcome Measures

Primary Outcomes (1)

• Change From Baseline (BL) in Modified Rodnan Skin Score (mRSS) at Week 52

  mRSS is the assessment of skin involvement includes semiquantitative estimation of skin thickness, pliability (hardness), and fixation to underlying structures (tethering).Cutaneous thickness is assessed in 17 body surface areas using a 0-3 scale, where mRSS of score 0="normal" with fine wrinkles but no skin thickness; score 1="mild" skin thickness; score 2= "moderate" skin thickness with difficulty in making skin folds and no wrinkles; and score 3="severe" skin thickness with inability to make skin folds between 2 examining fingers. Where higher score indicating more severe disease.

  Baseline, at Week 52

Secondary Outcomes (13)

• Change From Baseline in Forced Vital Capacity (FVC) at Week 52

  Baseline, at Week 52

• Proportion of Responders to the Treatment Based on the Revised Composite Response Index in Systemic Sclerosis (rCRISS) at Week 52

  At Week 52

• Change From Baseline in mRSS at Weeks 8, 12, 24, 28, 36, 44, 52

  Baseline, at Week 8, 12, 24, 28, 36, 44, 52

• Percent change from Baseline in mRSS at Week 52

  Baseline, at Week 52

• Change from Baseline in Percent Predicted FVC (ppFVC) at Week 52

  Baseline, at Week 52

Study Arms (3)

Nemolizumab Dose 1

EXPERIMENTAL

Drug: Nemolizumab

Nemolizumab Dose 2

EXPERIMENTAL

Drug: Nemolizumab

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Nemolizumab DRUG

Subcutaneous Injection

Also known as: CD14152

Nemolizumab Dose 1; Nemolizumab Dose 2

Placebo DRUG

Subcutaneous Injection

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• One of the following:
• Methotrexate (MTX) (\<25mg weekly) or
• Mycophenolate mofetil (MMF), mycophenolate sodium (MPS), or mycophenolic acid (MPA) (\<3000mg daily MMF, \<2160mg daily for MPS or MPA) NOTE: MTX should not be used in combination with MMF/MPS/MPA
• Participants with evidence for active or progressive disease.
• Men (whose female partner can become pregnant) and women of childbearing potential will be required to use effective means of contraception or commit to true abstinence, when this is in line with preferred and usual lifestyle of the participant, during the study and for at least 12 weeks after receiving the last study treatment.
• Female participants of non-childbearing potential
• Signed informed consent

You may not qualify if:

• Anti-centromere antibody positive at screening for participants with LcSSc.
• Anti-RNA polymerase 3 antibody positive for participants with a disease duration \>18months.
• 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.
• History of myocardial infarction in the last 6 months prior to screening.
• Pulmonary hypertension WHO Functional Class III or higher (as defined by WHO 2009) requiring treatment.
• Clinical signs of severe malabsorption in the opinion of the investigator or needing parenteral nutrition.
• History of scleroderma renal crisis (SRC) 6 months prior to screening.
• Participants with underlying chronic liver disease (Child Pugh A, B, C hepatic impairment).
• Body weight of \<30.0 kilogram (Kg) at screening or BL
• Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed, or unwilling to use appropriate contraception measures during the study period

Sponsors & Collaborators

• Galderma R&D: lead

Study Sites (3)

Galderma Investigational Site # 8743

Ann Arbor, Michigan, 48109-5000, United States

RECRUITING

Galderma Investigational Site#7096

Arlington, Texas, 76012, United States

RECRUITING

Galderma Investigational Site # 6213

Sankt Gallen, 9007, Switzerland

RECRUITING

MeSH Terms

Conditions

Scleroderma, Systemic; Scleroderma, Limited; Scleroderma, Diffuse; Lung Diseases, Interstitial

Interventions

nemolizumab

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Galderma Research and Development

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2025
• First Posted: July 2, 2025
• Study Start: February 20, 2026
• Primary Completion (Estimated): May 28, 2028
• Study Completion (Estimated): July 23, 2028
• Last Updated: March 31, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (2); CH (1)