Pulmonary SarcoidosisPhase 2NCT07867938
A Clinical Trial of Tulisokibart (MK-7240) in Participants With Pulmonary Sarcoidosis (MK-7240-016)
A Phase 2 study testing Tulisokibart and Background prednisone therapy in people with Pulmonary Sarcoidosis, run by Merck Sharp & Dohme LLC.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pulmonary Sarcoidosis
- What is being tested?
- Tulisokibart and Background prednisone therapy
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 158 participants
- Where
- No sites listed yet
- Study dates
- 6 Nov 2026to 11 Jan 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
About this study
Official title: 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
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
- Being tested
- Tulisokibart, Placebo, Background prednisone therapy
- Medical subject headings
- Sarcoidosis, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TulisokibartDrug
Also called MK-7240, PRA023
Subcutaneous (SC) administration
PlaceboOther
SC administration
Background prednisone therapyDrug
Oral administration
| Study group | Role | What they receive |
|---|---|---|
| Tulisokibart | Experimental | Participants receive background therapy of prednisone plus tulisokibart. Receives: Drug: Tulisokibart; Drug: Background prednisone therapy |
| Placebo | Placebo comparator | Participants receive background therapy of prednisone plus placebo. Receives: Other: Placebo; Drug: Background prednisone therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to approximately 52 weeks
Secondary outcomes (3)
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.
Measured: Up to approximately 52 weeks
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.
Measured: Up to approximately 66 weeks
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.
Measured: Up to approximately 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2026
- Study start6 Nov 2026 (estimated)
- Primary completion5 Oct 2029 (estimated)
- Study completion11 Jan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary SarcoidosisStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 158 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07867938
- Sponsor's protocol ID
- 7240-016
- Other IDs
- MK-7240-016, U1111-1330-0840, 2025-524270-42-00, 2025
- Status last verified
- Sep 2026
- First submitted
- 5 Oct 2026
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07867938
- Acronym / sponsor ID
- 7240-016
- Conditions
- Pulmonary Sarcoidosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 158 participants (estimated)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 6 Nov 2026 (estimated)
- Primary completion
- 5 Oct 2029 (estimated)
- Study completion
- 11 Jan 2030 (estimated)
- First posted
- 9 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tulisokibart | Experimental | Drug: Tulisokibart, Drug: Background prednisone therapyParticipants receive background therapy of prednisone plus tulisokibart. |
| Placebo | Placebo comparator | Other: Placebo, Drug: Background prednisone therapyParticipants receive background therapy of prednisone plus placebo. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TulisokibartAlso: MK-7240, PRA023Subcutaneous (SC) administration | Drug | Tulisokibart |
| PlaceboSC administration | Other | Placebo |
| Background prednisone therapyOral administration | Drug | Placebo, Tulisokibart |
Primary outcome
Time to First Worsening of Pulmonary Sarcoidosis (PS)
Time frame: 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.
3 secondary outcomes
Number of Participants Experiencing Worsening of PS
Time frame: Up to approximately 52 weeks
Number of Participants With One or More Adverse Events (AEs)
Time frame: Up to approximately 66 weeks
Number of Participants Who Discontinue Study Drug Due to One or More AEs
Time frame: Up to approximately 52 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- Merck Clinical Trials InformationLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Medical Director study director
Merck Sharp & Dohme LLC
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tulisokibart and Background prednisone therapy in people with Pulmonary Sarcoidosis, run by Merck Sharp & Dohme LLC.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to First Worsening of Pulmonary Sarcoidosis (PS) (time frame: Up to approximately 52 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026.