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    Summary
    EudraCT Number:2021-005206-10
    Sponsor's Protocol Code Number:PR200-104(MK-7240-007)
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-04-07
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedGermany - PEI
    A.2EudraCT number2021-005206-10
    A.3Full title of the trial
    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)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study of MK-7240/PRA023 in patients with Systemic Sclerosis Associated with Interstitial Lung Disease
    A.3.2Name or abbreviated title of the trial where available
    The ATHENA-SSc-ILD Study
    A.4.1Sponsor's protocol code numberPR200-104(MK-7240-007)
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT05270668
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorPrometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, NJ, USA)
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportPrometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, NJ, USA)
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPrometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, NJ, USA)
    B.5.2Functional name of contact pointClinical Operations
    B.5.3 Address:
    B.5.3.1Street Address3050 Science Park Road
    B.5.3.2Town/ citySan Diego
    B.5.3.3Post codeCA 92121
    B.5.3.4CountryUnited States
    B.5.6E-mailAthenaMM@prometheusbiosciences.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.2Product code MK-7240/PRA023
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNtulisokibart
    D.3.9.1CAS number 2648504-55-4
    D.3.9.2Current sponsor codeMK-7240/PRA023
    D.3.9.3Other descriptive nameMK-7240/PRA023
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number60
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Systemic sclerosis associated with interstitial lung disease
    E.1.1.1Medical condition in easily understood language
    Systemic sclerosis is a disease characterized by abnormal and excess fibrosis, a hardening of tissues and organs.
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10025109
    E.1.2Term Lung involvement in systemic sclerosis
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    • To assess the safety and tolerability of MK-7240/PRA023 in SSc-ILD
    • To compare the annual rate of change from Baseline in forced vital capacity (FVC) in mL of MK-7240/PRA023 vs. placebo over 50 weeks
    E.2.2Secondary objectives of the trial
    • To compare the change from Baseline in FVC in mL of MK-7240/PRA023 vs. placebo at Week 50
    • To compare the change from Baseline in high-resolution computer tomography (HRCT) quantitative interstitial lung disease - whole lung (QILD-WL) of MK-7240/PRA023 vs. placebo at Week 50
    • To compare proportion of subjects with an improvement in the revised Composite Response Index in Systemic Sclerosis (CRISS) score of MK-7240/PRA023 vs. placebo at Week 50
    • To assess the change from Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) of MK-7240/PRA023 vs. placebo at Week 50
    • To assess the change from Baseline in Living with Pulmonary Fibrosis (L-PF) patient-reported quality of life (QoL) outcome of MK-7240/PRA023 vs. placebo at Week 50
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Skin Biopsy Substudy: to assess change in histology and protein expression
    Pharmacokinetic Substudy: Fully characterize PK of MK-7240/PRA023 in subjects with SSc-ILD
    E.3Principal inclusion criteria
    1. Male or female ≥ 18 years of age.
    2. Subjects must meet the 2013 ACR/EULAR definition of SSc.
    3. Subjects must have had SSc onset (defined by first non-Raynaud symptom) ≤ 5 years (60 months) prior to screening.
    4. Subjects must have diffuse cutaneous scleroderma defined as any level of skin thickening proximal to the elbows and knees exclusive of the face and neck. Total mRSS must be 10 to 35 units, inclusive.
    5. Subjects must have SSc-related ILD of fibrotic disease in lung confirmed by HRCT ≥ 10% extent of involvement, assessed by central reading.
    6. FVC ≥ 45% of predicted normal.
    7. Diffusing capacity of lung for carbon monoxide (DLCO) ≥ 45% of predicted normal (corrected for hemoglobin [Hgb]).
    8. Meet at least one of the following criteria:
    a. C-reactive protein (CRP) > upper limit of normal (ULN)
    b. Erythrocyte sedimentation rate (ESR) > 28 mm/hr
    c. Positive for anti-topoisomerase (anti-Scl-70) antibody
    9. Background therapy is not required, but subjects receiving background therapy must meet drug stabilization requirements, as applicable:
    a. Either mycophenolate mofetil (not to exceed 3 g/day) or oral or subcutaneous methotrexate (not to exceed 25 mg/week) or azathioprine (not to exceed 150 mg/day) for ≥ 4 months prior to randomization (not more than 1 therapy) and on a stable dose for 4 weeks prior to randomization
    b. Subjects who have been on nintedanib for ≥ 6 months (and stable dose for at least 4 weeks) prior to randomization may enter the study provided that there has not been any improvement in FVC (% and absolute) from prior to the initiation of nintedanib therapy
    c. A stable dose of oral corticosteroids (≤ 10 mg/day prednisone equivalent) for 2 weeks prior to randomization. Inhaled and topical corticosteroids are permitted.
    10. A female subject is eligible to participate if not pregnant or breastfeeding, and at least one of the following conditions applies:
    • Is not a woman of childbearing potential (WOCBP)
    OR
    • Is a WOCBP and:
    - Uses an acceptable contraceptive method, or is abstinent from penilevaginal intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis),from at least 4 weeks prior to Day 1/Week 0, during the intervention period, and for at least 12 weeks after the last dose of study intervention. The Investigator should evaluate the potential for contraceptive method failure (i.e., noncompliance, recently initiated) in relationship to the first dose of study intervention.
    Contraceptive use by WOCBP should be consistent with local regulations regarding the methods of contraception for those participating in clinical
    studies. For any background medications, the local label should be followed for contraception.
    - Has a negative highly sensitive pregnancy test (urine or serum) as required by local regulations within 24 hours (for a urine test) or 72 hours (for a serum test) before the first dose of study intervention. If a urine test cannot be confirmed as negative (e.g., an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive.
    - Medical history, menstrual history, and recent sexual activity has been reviewed by the investigator to decrease the risk for inclusion of a WOCBP with an early undetected pregnancy.
    11. Able to provide written informed consent and understand and comply with the requirements of the study.
    E.4Principal exclusion criteria
    1. Subjects with a history of cancer within the last 5 years (other than non-melanoma skin cell cancers cured by local resection or cervical carcinoma in situ). Existing non-melanoma skin cell cancers must be removed prior to enrollment. Subjects with carcinoma in situ or localized cervical cancer, treated with definitive surgical intervention, are allowed.
    2. Subject has active TB or meets TB exclusionary parameters
    3. Subjects with chronic or recurrent infection (such as chronic pyelonephritis, osteomyelitis, and bronchiectasis).
    4. Subjects with any active infections (excluding fungal infections of nail beds) including, but not limited to, those that require IV or IM antimicrobial treatment 4 weeks or oral antimicrobial treatment 2 weeks prior to randomization.
    5.Subjects known to be infected with HBV, HCV, or HIV
    • Participants with positive HBsAg are excluded from the study.
    Participants with negative HBsAg and positive HBcAb must have further testing for HBV-DNA. Participants with HBV-DNA ≥LLOQ are not eligible
    for the study. Participants with HBV-DNA <LLOQ are eligible.
    • Participants with positive HCV Abs at Screening must have further testing for HCV RNA. Participants with HCV RNA ≥LLOQ are not eligible for the study. Participants with positive HCV Abs but HCV RNA <LLOQ are eligible. Subjects with successfully treated Hepatitis C with no recurrence for ≥ 1 year are allowed.
    • Participants with a history of HIV infection or who have a positive Ab test are not eligible for the study.
    6. Subjects with confirmed or suspected COVID-19 infection.
    Note: Subjects with recent confirmed or suspected COVID-19 infection may participate under the following conditions:
    • Subjects with COVID-19 infection confirmed by a PCR or an antigen test:
    - For asymptomatic subjects, randomization must be at least 10 days
    after the positive COVID-19 test.
    - For symptomatic subjects, randomization must be at least 10 days after onset of symptoms and at least 3 days after resolution of fever without the use of fever-reducing medications, and the participant must have a clinically meaningful improvement in symptoms.
    • Subjects with suspected COVID-19 infection:
    - For subjects with signs/symptoms suggestive of COVID-19 infection, a molecular (i.e., PCR) test must be performed to rule out COVID-19 infection before randomization.
    OR
    - Randomization must be at least 10 days after onset of symptoms and at least 3 days after resolution of fever without the use of fever-reducing
    medications, and the participant must have clinically meaningful improvement in symptoms
    7. Treatment with:
    a. Tofacitinib, upadacitinib, baricitinib, abrocitinib, or filgotinib within 4 weeks of randomization
    b. D-penicillamine, sulfasalazine, cyclosporine, or pirfenidone within 8 weeks of randomization
    c. Cyclophosphamide, tocilizumab, abatacept, leflunomide, tacrolimus, or any other approved biologics for rheumatic diseases within 3 months of randomization
    d. Intravenous immunoglobulin within 5 months of randomization
    e. Rituximab within 6 months of randomization.
    8. Prior exposure to MK-7240/PRA023 or other TL1A antagonists.
    E.5 End points
    E.5.1Primary end point(s)
    _ The proportion of subjects reporting adverse events (AEs), serious adverse events (SAEs), AEs leading to discontinuation, and markedly abnormal laboratory values
    _ To compare the annual rate of change from Baseline in FVC in mL of MK-7240/PRA023 vs. placebo over 50 weeks.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 50
    E.5.2Secondary end point(s)
    _To compare the change from Baseline in FVC in mL of MK-7240/PRA023 vs. placebo at Week 50.
    _To compare the change from Baseline in HRCT QILD-WL of MK-7240/PRA023 vs. placebo at Week 50
    _To compare proportion of subjects with an improvement in the revised CRISS score of MK-7240/PRA023 vs. placebo at Week 50
    _To assess the change from Baseline in HAQ-DI of MK-7240/PRA023 vs. placebo at Week 50
    _To assess the change from Baseline in L-PF patient-reported quality of life (QoL) outcome of MK-7240/PRA023 vs. placebo at Week 50
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 50
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA45
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Switzerland
    Australia
    Canada
    Israel
    United Kingdom
    United States
    Belgium
    France
    Germany
    Hungary
    Italy
    Netherlands
    Norway
    Poland
    Spain
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    EoT participation in a Member State of the EU is defined as the time at which it is deemed that a sufficient number of subjects have been recruited and completed the study as stated in the regulatory application (i.e., clinical trial application) and ethics application in the Member State. Poor recruitment (recruiting less than the anticipated number in the CTA) by a Member State is not a reason for premature termination but is considered a normal conclusion to the study in that
    Member State.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years7
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days16
    E.8.9.2In all countries concerned by the trial years7
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days16
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 114
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 38
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 92
    F.4.2.2In the whole clinical trial 152
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Subjects who complete the 50-week Treatment Period, irrespective of treatment assignment, will enter an OLE that will last 52 weeks, or until relevant country/region drug market authorization or
    access, starting at Week 50 visit after completion of all week 50 assessments. If the primary analysis following the last subject's Week 50 Visit does not support continued development in SSc-ILD, the study will be terminated.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2022-07-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-07-19
    P. End of Trial
    P.End of Trial StatusOngoing
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