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Phase 2 Safety and Efficacy Study of Tulisokibart (MK-7240/PRA023) in Subjects With Systemic Sclerosis Associated With Interstitial Lung Disease (SSc-ILD) (MK-7240-007)

NCT05270668 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 154

Last updated 2026-05-18

No results posted yet for this study

Summary

The purpose of this study is to assess the safety and efficacy of tulisokibart in participants with SSc-ILD.

Conditions

Interventions

DRUG

Tulisokibart

Tulisokibart administered at timepoints as directed by the protocol

DIAGNOSTIC_TEST

Companion diagnostic ( CDx)

CDx+ or CDx-

DRUG

Placebo

Placebo

Sponsors & Collaborators

  • Prometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

    lead INDUSTRY

Principal Investigators

  • Prometheus Biosciences · Clinical Trials Call Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-29
Primary Completion
2026-04-16
Completion
2029-07-31
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Belgium
  • Canada
  • Chile
  • France
  • Germany
  • Hungary
  • Israel
  • Italy
  • Mexico
  • Netherlands
  • Norway
  • Peru
  • Poland
  • Spain
  • Switzerland
  • Ukraine
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT05270668 on ClinicalTrials.gov