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Platform Clinical Study for Conquering Scleroderma

NCT06195072 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2026-02-04

No results posted yet for this study

Summary

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.

Conditions

  • Interstitial Lung Disease Due to Systemic Disease
  • Scleroderma

Interventions

DRUG

Amlitelimab

IP will be administered subcutaneously by the Investigator or designee as follows: * Amlitelimab or * Matching placebo

DRUG

BI 1015550 (Nerandomilast)

Study participants will take the active investigational product BI 1015550 (Nerandomilast) or matching placebo provided as film-coated tablets, administered orally BID.

DRUG

Placebo

see Experimental Arm intervention description

Sponsors & Collaborators

Principal Investigators

  • Kevin O'Shea · Scleroderma Research Foundation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-15
Primary Completion
2026-11-30
Completion
2026-11-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06195072 on ClinicalTrials.gov