A Clinical Trial of Tulisokibart (MK-7240) in Participants With Pulmonary Sarcoidosis (MK-7240-016)

NCT07867938 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 5 other identifiers: 7240-016MK-7240-016U1111-1330-08402025-524270-42-002025
• Study Type: interventional
• Target: 158
• Locations: 0 countries
• Sites: N/A

Brief Summary

Researchers are looking for new ways to treat active pulmonary sarcoidosis (PS). This trial will help researchers learn if a trial medicine called tulisokibart can treat symptoms of active PS. The goal of this trial is to learn if tulisokibart works better than placebo to increase the length of time until PS gets worse.

Conditions

Pulmonary Sarcoidosis

Outcome Measures

Primary Outcomes (1)

• Time to First Worsening of Pulmonary Sarcoidosis (PS)

  Worsening of PS is based on clinical judgment of worsening PS, along with pulmonary function tests and/or impaired or unacceptable loss of quality of life as measured by the King's Sarcoidosis Questionnaire (KSQ)-lung score. The time to first worsening of PS will be reported.

  Up to approximately 52 weeks

Secondary Outcomes (3)

• Number of Participants Experiencing Worsening of PS

  Up to approximately 52 weeks

• Number of Participants With One or More Adverse Events (AEs)

  Up to approximately 66 weeks

• Number of Participants Who Discontinue Study Drug Due to One or More AEs

  Up to approximately 52 weeks

Study Arms (2)

Tulisokibart

EXPERIMENTAL

Participants receive background therapy of prednisone plus tulisokibart.

Drug: Tulisokibart; Drug: Background prednisone therapy

Placebo

PLACEBO COMPARATOR

Participants receive background therapy of prednisone plus placebo.

Other: Placebo; Drug: Background prednisone therapy

Interventions

Tulisokibart DRUG

Subcutaneous (SC) administration

Also known as: MK-7240, PRA023

Tulisokibart

Placebo OTHER

SC administration

Placebo

Background prednisone therapy DRUG

Oral administration

Placebo; Tulisokibart

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Has a diagnosis of sarcoidosis of ≥6 months before Screening confirmed by tissue biopsy
• Has lung parenchymal involvement consistent with pulmonary sarcoidosis (PS) by chest X-ray or chest high-resolution computed tomography (HRCT) either via historical evidence or at Screening
• Has active PS within 3 months before Screening

You may not qualify if:

• Has a history of cancer and is disease free for \<5 years
• Has cardiac, ocular, neurosarcoidosis, or other manifestations of sarcoidosis that requires systemic treatment that may interfere with protocol specifications, or has a clinically significant electrocardiogram abnormality that requires evaluation or intervention
• Is receiving treatment for pulmonary hypertension
• Has a history of fungal respiratory infection within 12 months before screening without documentation of completed treatment
• Has a diagnosis of or currently has a clinical presentation consistent with Löfgren syndrome
• Has active tuberculosis (TB) or history of active TB
• Has any condition that may interfere with the ability to adhere to oral corticosteroid therapy or taper
• Is a current smoker defined as smoking or vaping of inhaled preparations of nicotine, tobacco, or cannabis preparations within 6 months before Screening

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Links

• Merck Clinical Trials Information

MeSH Terms

Conditions

Sarcoidosis, Pulmonary

Condition Hierarchy (Ancestors)

Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases; Sarcoidosis; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Hypersensitivity, Delayed; Hypersensitivity; Immune System Diseases

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

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: October 5, 2026
• First Posted: October 9, 2026
• Study Start (Estimated): November 6, 2026
• Primary Completion (Estimated): October 5, 2029
• Study Completion (Estimated): January 11, 2030
• Last Updated: October 9, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share