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)

Phase 2Active Not RecruitingNCT05270668

Prometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)154 enrolled

Overview

The purpose of this study is to assess the safety and efficacy of tulisokibart in participants with SSc-ILD.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

154

Conditions

Diffuse Cutaneous Systemic Sclerosis Interstitial Lung Disease

Interventions

TulisokibartDRUG

Tulisokibart administered at timepoints as directed by the protocol

Companion diagnostic ( CDx)DIAGNOSTIC_TEST

CDx+ or CDx-

PlaceboDRUG

Placebo

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (95)

Outcomes

Primary Outcomes

Number of Participants who Experience an Adverse Event (AE)

An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. The number of participants who experience an AE will be reported.

Time frame: Up to Week 50

Number of Participants who Experience a Serious Adverse Event (SAE)

An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. The number of participants who experience an SAE will be reported.

Time frame: Up to Week 50

Number of Participants who Discontinue due to an AE

An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. The number of participants who discontinue due to an AE will be reported.

Time frame: Up to Week 50

Change from Baseline in the Annual Rate of Change in Forced Vital Capacity (FVC) at Week 50

FVC, as measured in milliliters by spirometry, is the amount of air forcibly exhaled from the lungs after taking the deepest breath possible.

Time frame: Baseline and up to Week 50

Secondary Outcomes

Change from Baseline in FVC at Week 50

FVC, as measured in milliliters by spirometry, is the amount of air forcibly exhaled from the lungs after taking the deepest breath possible.

Time frame: Baseline and Week 50

Change from Baseline in High-Resolution Computer Tomography (HRCT) Quantitative Interstitial Lung Disease - Whole Lung (QILD-WL) at Week 50

QILD-WL will be measured as percent lung involvement using HRCT.

Data from ClinicalTrials.gov

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Mayo Clinic - Scottsdale ( Site 4014)

Phoenix, Arizona, United States

Pacific Arthritis Care Center ( Site 4008)

Los Angeles, California, United States

Cedars Sinai Medical Center ( Site 4010)

Los Angeles, California, United States

UCLA School of Medicine ( Site 4006)

Los Angeles, California, United States

Stanford Health Care ( Site 4009)

Palo Alto, California, United States

National Jewish Health Medical Center ( Site 4015)

Denver, Colorado, United States

Yale University ( Site 4017)

New Haven, Connecticut, United States

MedStar Georgetown University Hospital ( Site 4005)

Washington D.C., District of Columbia, United States

Johns Hopkins Asthma and Allergy Center [Baltimore, MD] ( Site 4018)

Baltimore, Maryland, United States

Massachusetts General Hospital ( Site 4003)

Boston, Massachusetts, United States

...and 85 more locations

Time frame: Baseline and Week 50

Percentage of Participants with an Improvement in the Revised Composite Response Index in Systemic Sclerosis (CRISS) Score at Week 50

The Revised CRISS is a two-step process designed to evaluate the likelihood of improvement in early SSc. The first step assesses worsening or incident cases of internal organ involvement (scleroderma renal crisis, pulmonary arterial hypertension, congestive heart failure, ILD, severe gastrointestinal dysmotility requiring parenteral or enteral nutrition, and digital ischemia requiring hospitalization, gangrene, or amputation). The second step assesses changes from baseline in five core set measures: modified Rodnan skin score (mRSS), percent predicted forced vital capacity (FVC%), health assessment questionnaire-disability index (HAQ-DI), patient (PGA), and physician (PhGA) global assessments.

Time frame: Baseline and Week 50

Change from Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 50

HAQ is an instrument to assess physical function. It consists of 20 questions, covering eight types of activities. For each question, scores range from 0 to 3 (0 = without any difficulty; 1 = with some difficulty; 2 = with much difficulty or with assistance; 3 = unable to do). HAQ Disability Index (HAQ-DI) score is the average of the highest score in each of the eight categories.

Time frame: Baseline and Week 50

Change from Baseline in Living with Pulmonary Fibrosis (L-PF) Quality of Life (QoL) Outcome at Week 50

The L-PF is a questionnaire designed to assess the quality of life of patients with pulmonary fibrosis. It contains 44 questions (items) split into two modules, 23 which assess symptoms (including shortness of breath, cough, and fatigue) and 21 which assess impacts to quality of life. Individual items are scored on a 5-point scale (0 = Not at All to 4 = Extremely). Overall scores range from 0 to 100 with higher scores indicating a greater impairment.

Time frame: Baseline and Week 50