Phase 2 Safety and Efficacy Study of Tulisokibart (MK-7240/PRA023) in Subjects With Systemic Scle… (NCT05270668) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Phase 2 Safety and Efficacy Study of Tulisokibart (MK-7240/PRA023) in Subjects With Systemic Sclerosis Associated With Interstitial Lung Disease (SSc-ILD) (MK-7240-007)
United States154 participantsStarted 2022-03-29
Plain-language summary
The purpose of this study is to assess the safety and efficacy of tulisokibart in participants with SSc-ILD.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Has confirmed diagnosis of systemic sclerosis with onset of disease ≤ 5 years ago.
* Has diffuse cutaneous scleroderma
* Has systemic sclerosis related interstitial lung disease confirmed by HRCT
* FVC ≥ 45% of predicted normal
* Diffusing capacity of lung for carbon monoxide (DLCO)≥ 45% of predicted normal
* If on background therapy, meets stable dosing requirements for nintedanib, mycophenolate mofetil (MMF), methotrexate (MTX) OR azathioprine, and corticosteroids
* Women of childbearing potential are eligible to participate if not pregnant or breastfeeding and either willing to use an acceptable contraceptive method or sexually abstinent
* Able to provide written informed consent and understand and comply with the requirements of the study
Exclusion Criteria:
* Has an airway obstruction per pulmonary function test (PFT) or clinically significant pulmonary arterial hypertension
* Has current clinical diagnosis of another inflammatory connective tissue disease
* Has any active infections, a serious infection within the past 3 months, or chronic bacterial infection
* Is a current smoker or smoking within 6 months of screening
* Has any concomitant medical conditions that, in the opinion of the investigator, might place them in unacceptable risk for participation in the study
* Meets the protocol criteria for important laboratory exclusion criteria
What they're measuring
1
Number of Participants who Experience an Adverse Event (AE)
Timeframe: Up to Week 50
2
Number of Participants who Experience a Serious Adverse Event (SAE)
Timeframe: Up to Week 50
3
Number of Participants who Discontinue due to an AE
Timeframe: Up to Week 50
4
Change from Baseline in the Annual Rate of Change in Forced Vital Capacity (FVC) at Week 50
Timeframe: Baseline and up to Week 50
Trial details
NCT IDNCT05270668
SponsorPrometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)