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)

• ClinicalTrials.gov Identifier: NCT05270668
• Recruitment Status: Recruiting
• First Posted: March 8, 2022
• Last Update Posted: May 7, 2024
• Sponsor: Prometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
• Information provided by (Responsible Party): Prometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Tracking Information

• First Submitted Date: February 27, 2022
• First Posted Date: March 8, 2022
• Last Update Posted Date: May 7, 2024
• Actual Study Start Date: July 13, 2022
• Estimated Primary Completion Date: December 19, 2025 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: December 20, 2023)

• 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.
• 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.
• 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.
• 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.

Original Primary Outcome Measures (submitted: March 7, 2022)

• Incidence of AE, SAE and AE leading to discontinuation [ Time Frame: Week 50 ]
  Safety and tolerability
• Annual change of forced vital capacity (FVC) [ Time Frame: Week 50 ]
  Comparison of annual rate of change in FVC

Current Secondary Outcome Measures (submitted: December 20, 2023)

• 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.
• 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.
• 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.
• 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.
• 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.

Original Secondary Outcome Measures (submitted: March 7, 2022)

• Change of FVC [ Time Frame: Week 50 ]
  Comparison of change in FVC
• Annual rate of change in percent predicted FVC [ Time Frame: Week 50 ]
  Comparison of annual rate of change in FVC in percent predicted
• Change in high-resolution computer tomography (HRCT) [ Time Frame: Week 50 ]
  Comparison of change in HRCT quantitative ILD
• Change in American College of Rheumatology Combined Response Index in Systemic Sclerosis (ACR CRISS) [ Time Frame: Week 50 ]
  Proportion of subjects with improvement of ACR CRISS

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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)
• 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)
• Brief Summary: The purpose of this study is to assess the safety and efficacy of tulisokibart in participants with SSc-ILD.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment

Condition

• Diffuse Cutaneous Systemic Sclerosis
• Interstitial Lung Disease

Intervention

• Drug: Tulisokibart
  Tulisokibart administered at timepoints as directed by the protocol
  Other Names:

  • PRA023
  • MK-7240
• Diagnostic Test: Companion diagnostic ( CDx)
  CDx+ or CDx-
• Drug: Placebo
  Placebo

Study Arms

• Experimental: Tulisokibart
  Tulisokibart IV administered by IV infusion
  Interventions:

  • Drug: Tulisokibart
  • Diagnostic Test: Companion diagnostic ( CDx)
• Placebo Comparator: Placebo
  Placebo administered by IV infusion
  Interventions:

  • Diagnostic Test: Companion diagnostic ( CDx)
  • Drug: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: December 20, 2023): 152
• Original Estimated Enrollment (submitted: March 7, 2022): 100
• Estimated Study Completion Date: December 30, 2028
• Estimated Primary Completion Date: December 19, 2025 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

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

• Listed Location Countries: Australia, Belgium, Canada, France, Germany, Hungary, Israel, Italy, Netherlands, Norway, Poland, Spain, Switzerland, United Kingdom, United States

Administrative Information

• NCT Number: NCT05270668
• Other Study ID Numbers: 7240-007; PR200-104 ( Other Identifier: PrometheusBio ); MK-7240-007 ( Other Identifier: Merck ); 2021-005206-10 ( EudraCT Number )
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• 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

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

• Current Responsible Party: Prometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
• Original Responsible Party: Same as current
• Current Study Sponsor: Prometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Prometheus Biosciences; Clinical Trials Call Center

• PRS Account: Prometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
• Verification Date: May 2024