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Not yet recruitingNCT07867938Updated Oct 9, 2026

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

A Phase 2 interventional study of Tulisokibart and Placebo in Pulmonary Sarcoidosis, sponsored by Merck Sharp & Dohme LLC. Not yet recruiting. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-10-09.

Sponsored by Merck Sharp & Dohme LLC (part of Merck & Co., Inc) · Phase 2, Interventional, and Treatment

Updated Oct 9, 2026Newly registeredGo to Updates ↓
Phase
Phase 2
Study type
Interventional
Enrollment
158
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Pulmonary Sarcoidosis

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03

In context

Sarcoidosis, Pulmonary

67 studies on the registry are indexed under Sarcoidosis, Pulmonary; 17 are open to participants now.

This study's planned enrollment of 158 is above the median of 55 across 51 interventional studies indexed under Sarcoidosis, Pulmonary.

Browse Sarcoidosis, Pulmonary studies →

Lead sponsor

Merck Sharp & Dohme LLC is the lead sponsor of 2,160 studies on the registry; 134 are open to participants now.

Of its 497 completed or terminated interventional studies of FDA-regulated products, 369 (74%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
158 participants (estimated)

Study arms

  • Experimental
    Tulisokibart

    Participants receive background therapy of prednisone plus tulisokibart.

    Drug: Tulisokibart · Drug: Background prednisone therapy

  • Placebo comparator
    Placebo

    Participants receive background therapy of prednisone plus placebo.

    Other: Placebo · Drug: Background prednisone therapy

Interventions

  • Subcutaneous (SC) administration

    Also known as: MK-7240, PRA023

  • OtherPlacebo

    SC administration

  • DrugBackground prednisone therapy

    Oral administration

06

What researchers measure

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.

    Time frame: Up to approximately 52 weeks

Secondary outcomes

  1. Number of Participants Experiencing Worsening of 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 KSQ-lung score. The number of participants with worsening of PS will be reported.

    Time frame: Up to approximately 52 weeks

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

    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.

    Time frame: Up to approximately 66 weeks

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

    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.

    Time frame: Up to approximately 52 weeks

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Yes — https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Data sharing details ↗ · externaldatasharing-msd.com

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Nov 2026; primary completion for Oct 2029, 34 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 5, 2026
First posted
Oct 9, 2026
StartEst.
Nov 6, 2026
Primary completionEst.
Oct 5, 2029
CompletionEst.
Jan 11, 2030
Last update
Oct 9, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Oct 9, 2026
Show all 1 update
  1. Oct 9, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07867938
Responsible party
Sponsor
First posted
Oct 9, 2026
Start date
Nov 6, 2026 (estimated)
Primary completion
Oct 5, 2029 (estimated)
Completion
Jan 11, 2030 (estimated)
Last update
Oct 9, 2026

Study contacts

Medical Director
study director · Merck Sharp & Dohme LLC

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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