Diffuse Cutaneous Systemic Sclerosis, Interstitial Lung Disease
Conditions
Keywords
ATHENA SSc-ILD, ATHENA, Diffuse Cutaneous Scleroderma, Interstitial Lung Disease
Brief summary
The purpose of this study is to assess the safety and efficacy of tulisokibart in participants with SSc-ILD.
Interventions
DRUGTulisokibart
Tulisokibart administered at timepoints as directed by the protocol
DIAGNOSTIC_TESTCompanion diagnostic ( CDx)
CDx+ or CDx-
DRUGPlacebo
Placebo
Sponsors
Prometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants who Experience an Adverse Event (AE) | 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) | 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 | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in FVC at Week 50 | 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 | 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 | 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 | 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 | 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. |
Countries
Argentina, Australia, Belgium, Canada, Chile, France, Germany, Hungary, Israel, Italy, Mexico, Netherlands, Norway, Peru, Poland, Spain, Switzerland, Ukraine, United Kingdom, United States
Contacts
STUDY_DIRECTORPrometheus Biosciences
Clinical Trials Call Center
Outcome results
None listed