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

NCT07867938 — Phase 2, Not yet recruiting, 158 participants, Merck Sharp & Dohme LLC

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A Phase 2 Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of Tulisokibart in Participants With Active Pulmonary Sarcoidosis

Registry	NCT07867938
Status	Not yet recruiting
Phase	Phase 2
Study type	Interventional; randomized, parallel, masking: quadruple, treatment
Enrollment	158 (Estimated)
Sponsor	Merck Sharp & Dohme LLC (Industry)
Conditions	Pulmonary Sarcoidosis
Interventions	Tulisokibart, Placebo, Background prednisone therapy (Drug, other)
Dates	start 2026-11-06 (estimated), primary completion 2029-10-05 (estimated), completion 2030-01-11 (estimated), first posted 2026-10-09, last updated 2026-10-09

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Tulisokibart	Experimental	Drug: Tulisokibart; Drug: Background prednisone therapy	Participants receive background therapy of prednisone plus tulisokibart.
Placebo	Placebo comparator	Other: Placebo; Drug: Background prednisone therapy	Participants receive background therapy of prednisone plus placebo.

Tulisokibart (Drug), also known as MK-7240, PRA023: Subcutaneous (SC) administration
Placebo (Other): SC administration
Background prednisone therapy (Drug): Oral administration

+Outcome measures

Primary outcomes

Time to First Worsening of Pulmonary Sarcoidosis (PS) [Up to approximately 52 weeks]: 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.

Secondary outcomes

Number of Participants Experiencing Worsening of PS [Up to approximately 52 weeks]: 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 KSQ-lung score. The number of participants with worsening of PS will be reported.
Number of Participants With One or More Adverse Events (AEs) [Up to approximately 66 weeks]: An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants with one or more adverse events will be reported.
Number of Participants Who Discontinue Study Drug Due to One or More AEs [Up to approximately 52 weeks]: An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinue study drug due to one or more AEs will be reported.

+Eligibility

Sex: All, ages: 18 Years to 75 Years

Inclusion Criteria:

The main inclusion criteria include but are not limited to the following:

* 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

Exclusion Criteria:

The main exclusion criteria include but are not limited to the following:

* 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

+Investigators

Medical Director, Study director, Merck Sharp & Dohme LLC

+Funding

NIH grants: 2025

My Notes

Public

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