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

Part of paid clinical trials in Ann Arbor, Michigan.

Sponsor
Galderma R&D
Study ID
NCT07047690
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Nemolizumab — DRUG
    Subcutaneous Injection
  • Placebo — DRUG
    Subcutaneous Injection

Study Details

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.

Key Dates

Start date
Feb 20, 2026
Status verified
Nov 2025
Primary completion
May 28, 2028
Completion
Jul 23, 2028

Study Design

Enrollment
162 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Nemolizumab Dose 1
  • Experimental: Nemolizumab Dose 2
  • Placebo Comparator: Placebo

Primary Outcome Measure

Change From Baseline (BL) in Modified Rodnan Skin Score (mRSS) at Week 52 [ Time Frame: Baseline, at Week 52 ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Galderma Investigational Site # 8743Ann ArborMichigan48109-5000
Galderma Project Manager
Galderma Investigational Site#7096ArlingtonTexas76012
Galderma Project Manager

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