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NCT Number: NCT05270668

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)

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

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Diffuse Cutaneous Systemic Sclerosis Connective Tissue Diseases Interstitial Lung Disease Lung Diseases Lung Diseases, Interstitial Respiratory Tract Diseases Scleroderma, Diffuse Scleroderma, Systemic Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Consultorios Médicos Dr. Doreski ( Site 4800), CABA, Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tulisokibart

Drug

Tulisokibart administered at timepoints as directed by the protocol

Other names: PRA023, MK-7240

Companion diagnostic ( CDx)

Diagnostic Test

CDx+ or CDx-

Placebo

Drug

Placebo

Primary outcomes

  1. Number of Participants who Experience an Adverse Event (AE)

    Time frame: Up to Week 50

    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.

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

    Time frame: Up to Week 50

    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.

  3. Number of Participants who Discontinue due to an AE

    Time frame: Up to Week 50

    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.

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

    Time frame: Baseline and up to 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.

Secondary outcomes

  1. Change from Baseline in FVC at Week 50

    Time frame: Baseline and 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.

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

    Time frame: Baseline and Week 50

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

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

    Time frame: Baseline and 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.

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

    Time frame: Baseline and 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.

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

    Time frame: Baseline and 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.

Sponsors and collaborators

Lead sponsor

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

Industry

Registry information

Official study title

A Double Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MK-7240/PRA023 in Subjects With Systemic Sclerosis Associated With Interstitial Lung Disease (SSc-ILD)

Acronym: ATHENA-SSc-ILD

Important dates

Study start
2022
Primary completion
2026
Study completion
2029
First posted
Mar 8, 2022
Registry last updated
May 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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