Recruiting
Phase 2

Tulisokibart

Sponsor:

Merck Sharp & Dohme LLC

Code:

NCT07867938

Conditions

Pulmonary Sarcoidosis

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Tulisokibart

Placebo

Background prednisone therapy

Study Details

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

Study ID

NCT07867938

Start date

Nov 3, 2026

Status verified date

Nov, 2026

Completion date

Jan 11, 2030

Anticipated

Primary completion date

Oct 5, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

158 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Tulisokibart

Participants receive background therapy of prednisone plus tulisokibart.

placebo comparator: Placebo

Participants receive background therapy of prednisone plus placebo.

Interventions

Tulisokibart

Subcutaneous (SC) administration

Placebo

SC administration

Background prednisone therapy

Oral administration

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Toll Free Number

1-888-577-8839Trialsites@msd.com

Locations

Care Access Research Llc ( Site 2725)

Recruiting

Shreveport, Louisiana, United States, 71105

Contacts

Study Coordinator

318-209-3290

More Information

Sponsor

Merck Sharp & Dohme LLC

Last update posted

Nov 9, 2026

Last verified

Nov, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-10. This information was provided to ClinicalTrials.gov by Merck Sharp & Dohme LLC on 2026-11-09. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.