Tulisokibart for active pulmonary sarcoidosis: a phase 2 trial

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the safety and effectiveness of tulisokibart compared with placebo in participants with active pulmonary sarcoidosis. Enrolled adults have had sarcoidosis for at least six months with lung involvement and recent worsening disease. Participants may also be on background prednisone therapy. The trial aims to determine if tulisokibart can extend the time to disease progression. It is conducted at a single site in Shreveport, Louisiana under Merck Sharp & Dohme's oversight.

Why it matters

Who can join: the full rules

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

Where it's running

• Care Access Research Llc ( Site 2725)
  Shreveport, Louisiana, United States Recruiting

Study contacts

• Study coordinator: Toll Free Number
• Email: Trialsites@msd.com
• Phone: 1-888-577-8839

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Exploring genetic factors in lung disease development

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  Recruiting National Institutes of Health Clinical Center (CC) · Bethesda, Maryland and 1 other locations · NCT00001532

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.