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    Summary
    EudraCT Number:2021-005206-10
    Sponsor's Protocol Code Number:PR200-104
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-04-01
    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 ConcernedPoland - Office for Medicinal Products
    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 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 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
    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.
    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.
    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.
    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 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.3.9.2Current sponsor codePRA023
    D.3.9.3Other descriptive namePRA023
    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 100000004855
    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 PRA023 in SSc-ILD
    • To compare the annual rate of change from Baseline in forced vital capacity (FVC), of PRA023 vs. placebo over 50 weeks
    E.2.2Secondary objectives of the trial
    • To compare the change from Baseline in FVC at Week 50
    • To compare the change from Baseline in high-resolution computer tomography (HRCT) at Week 50
    • To compare the annual rate of change in percent predicted FVC
    • To compare proportion of subjects with an improvement in the American College of Rheumatology Combined Response Index in Systemic Sclerosis (ACR CRISS) score 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 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 15 to 35 units, inclusive.
    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. CRP > upper limit of normal (ULN)
    b. Erythrocyte sedimentation rate (ESR) > 28 mm/hr
    c. Positive for anti-topoisomerase (anti-Scl-70) antibody
    9. 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.For subjects who are women of childbearing potential (WOCBP) involved in any sexual intercourse that could lead to pregnancy, the subject has used two highly effective methods of contraception for at least 4 weeks prior to Day 1 and agrees to continue to use two highly effective methods of contraception until at least 12 weeks after the last dose of study drug.
    11. Male subjects and/or their partners must use two highly effective methods of contraception from screening to 12 weeks after the last dose of study drug.
    12. Male subjects must refrain from sperm donation or banking from randomization to 12 weeks after the last dose of study drug.
    13. Able to provide written informed consent and understand and comply with the requirements of the study.
    E.4Principal exclusion criteria
    1. WOCBP and men with female partners of childbearing potential who are unwilling or unable to use two highly effective methods of contraception to avoid pregnancy for the entire study period and for up to 12 weeks after the last dose of study drug.
    2.Women who are pregnant or breastfeeding.
    3.Women with a positive pregnancy test on enrollment or prior to randomization.
    4. Airway obstruction (pre-bronchodilator Forced Expiratory Volume in 1 second (FEV1)/FVC < 0.65).
    5.Clinically significant pulmonary arterial hypertension (PAH) on right heart catheterization and requiring 2 oral or inhaled therapies or 1 parenteral therapy.
    6.Other clinically significant pulmonary abnormalities.
    7.History of autologous stem cell or lung transplantation.
    8.Positive for serum anti-centromere antibody.
    9.Current clinical diagnosis of another inflammatory connective tissue disease (e.g., systemic lupus erythematosus, rheumatoid arthritis, mixed connective tissue disease, or dermato/polymyositis). Concomitant scleroderma-associated myopathy, fibromyalgia, and secondary Sjögren's are allowed.
    10.Subjects who are scheduled or anticipate the need for surgery, aside from dermatologic procedures.
    11.Subjects who have a history of clinically significant drug or alcohol abuse.
    12.Subjects who are current smoker (including e-cigarettes) / smoking within 6 months of screening.
    13.Current symptoms of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal (including severe recurrent aspiration), cardiac, neurological, ophthalmologic, or cerebral disease. Concomitant medical conditions that in the opinion of the Investigator might place the subject at unacceptable risk for participation in this study.
    14.Subjects with a history of cancer within the last 5 years (other than non-melanoma skin cell cancers cured by local resection or cervical 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.
    15. Subjects at risk for tuberculosis (TB). Specifically, subjects with:
    a.A history of active TB which was not successfully treated with completion of treatment;b.Current clinical, radiographic, or laboratory evidence of active TB;c.Latent TB which was not successfully treated. Subjects with a positive TB screening test indicative of latent TB will not be eligible for the study unless active TB infection has been ruled out, and an appropriate course of intervention for latent TB has been initiated at least 2 weeks prior to randomization, and no evidence of active TB during screening.
    16.Subjects with any serious infection within the last 3 months, or any chronic bacterial infection (such as chronic pyelonephritis, osteomyelitis, and bronchiectasis).
    17.Female subjects who have had a breast cancer screening that is suspicious for malignancy, and in whom the possibility of malignancy cannot be reasonably excluded following additional clinical, laboratory, or other diagnostic evaluations.
    18.Subjects with any active infections (excluding fungal infections of nail beds) including, but not limited to, those that require IV antimicrobial treatment 4 weeks or oral antimicrobial treatment 2 weeks prior to randomization. Subjects with evidence of Human Immunodeficiency Virus (HIV), Hepatitis B, or Hepatitis C infection detected during screening are also excluded, but subjects with successfully treated Hepatitis C with no recurrence for ≥ 1 year are allowed. Subjects with active documented or suspected COVID-19 infection within 4 weeks of randomization or asymptomatic positive severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) polymerase chain reaction (PCR) test within 2 weeks of randomization are excluded.
    19.Subjects who have received any live vaccines within 3 months of the anticipated first dose of study medication or who will have need of a live vaccine at any time during the study or within 12 weeks after the last dose;20. Any of the following lab values: Hgb < 8.0 g/dL (80 g/L);White blood cell (WBC) < 2,500/mm3 (2.5 x 109/L);Neutrophils < 1,000/mm3 (1 x 109/L);Platelets < 100,000/mm3 (100 x 109/L);Serum creatinine > 2 times upper limit of normal (ULN) or estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73m2;Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2 times ULN;Any other laboratory test results that, in the opinion of the Investigator, might place the subject at unacceptable risk for participation in this study.
    21.Treatment with: a. D-penicillamine, sulfasalazine, cyclosporine, tofacitinib or pirfenidone within 8 weeks of randomization;b.Cyclophosphamide, tocilizumab, abatacept, leflunomide, tacrolimus, or any other approved biologics for rheumatic diseases within 3 months of randomization;c.Rituximab within 6 months of randomization.22.Investigational chemical agent within 30 days or other investigational biologic agent within 8 weeks or 5 half-lives (whichever is longer) of randomization.23.Prior exposure to PRA023.
    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
    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
    _To compare the annual rate of change in percent predicted FVC
    _To compare the change from Baseline in HRCT
    _To compare proportion of subjects with an improvement of the ACR CRISS score
    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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA39
    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
    Belgium
    Canada
    France
    Germany
    Hungary
    Israel
    Italy
    Netherlands
    Norway
    Poland
    Spain
    United Kingdom
    United States
    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
    End of trial in all other participating countries is defined as last subject last visit (LSLV) or the last study procedure, whichever occurs last.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months1
    E.8.9.1In the Member State concerned days14
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months3
    E.8.9.2In all countries concerned by the trial days14
    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: 80
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 61
    F.4.2.2In the whole clinical trial 100
    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 have the option to enter an OLE that will last 52 weeks, starting at Week 50 visit after completion of all Week 50 assessments. Subjects in the double-blind phase of the study who do not enter the OLE will undergo a post treatment follow up of 12 weeks. Subjects in the OLE who discontinue study treatment with PRA023 before Week 52 will enter the post treatment follow up period of 12 weeks
    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 Decision2022-04-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-03-24
    P. End of Trial
    P.End of Trial StatusOngoing
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