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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) (ATHENA-SSc-ILD)

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ClinicalTrials.gov Identifier: NCT05270668
Recruitment Status : Recruiting
First Posted : March 8, 2022
Last Update Posted : April 25, 2024
Sponsor:
Information provided by (Responsible Party):
Prometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

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

Condition or disease Intervention/treatment Phase
Diffuse Cutaneous Systemic Sclerosis Interstitial Lung Disease Drug: Tulisokibart Diagnostic Test: Companion diagnostic ( CDx) Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 152 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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)
Actual Study Start Date : July 13, 2022
Estimated Primary Completion Date : December 19, 2025
Estimated Study Completion Date : December 30, 2028

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Tulisokibart
Tulisokibart IV administered by IV infusion
 Drug: Tulisokibart
Tulisokibart administered at timepoints as directed by the protocol
Other Names:
  • PRA023
  • MK-7240

Diagnostic Test: Companion diagnostic ( CDx)
CDx+ or CDx-
Placebo Comparator: Placebo
Placebo administered by IV infusion
 Diagnostic Test: Companion diagnostic ( CDx)
CDx+ or CDx-

Drug: Placebo
Placebo


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05270668


Contacts
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Contact: Toll Free Number 1-888-577-8839 Trialsites@merck.com

Locations
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Sponsors and Collaborators
Prometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Investigators
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Study Director: Prometheus Biosciences Clinical Trials Call Center
More Information
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Additional Information:

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Responsible Party: Prometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
ClinicalTrials.gov Identifier: NCT05270668    
Other Study ID Numbers: 7240-007
PR200-104 ( Other Identifier: PrometheusBio )
MK-7240-007 ( Other Identifier: Merck )
2021-005206-10 ( EudraCT Number )
First Posted: March 8, 2022    Key Record Dates
Last Update Posted: April 25, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
URL: http://engagezone.msd.com/ds_documentation.php

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Keywords provided by Prometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA):
ATHENA SSc-ILD
ATHENA
Diffuse Cutaneous Scleroderma
Interstitial Lung Disease
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Interstitial
Scleroderma, Systemic
Scleroderma, Diffuse
Sclerosis
 Pathologic Processes
Respiratory Tract Diseases
Connective Tissue Diseases
Skin Diseases