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    Summary
    EudraCT Number:2022-000847-62
    Sponsor's Protocol Code Number:ATI-450-PsA-201
    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:2022-08-31
    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 number2022-000847-62
    A.3Full title of the trial
    A Phase 2a, Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Zunsemetinib vs Placebo in Patients with Moderate-to-Severe Active Psoriatic Arthritis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 2a, Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Zunsemetinib vs Placebo in Patients with Moderate-to-Severe Active Psoriatic Arthritis
    A.4.1Sponsor's protocol code numberATI-450-PsA-201
    A.5.4Other Identifiers
    Name:IND NumberNumber:139858
    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 SponsorAclaris Therapeutics, 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 supportAclaris Therapeutics, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAclaris Therapeutics, Inc.
    B.5.2Functional name of contact pointAjay Aggarwal
    B.5.3 Address:
    B.5.3.1Street Address640 Lee Rd, Ste 200
    B.5.3.2Town/ cityWayne
    B.5.3.3Post codePA 19087
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1484265-1610
    B.5.6E-mailaaggarwal@aclaristx.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.3.1Product nameZunsemetinib
    D.3.2Product code ATI-450
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNZunsemetinib
    D.3.9.1CAS number 1640282-42-3
    D.3.9.2Current sponsor codeATI-450
    D.3.9.3Other descriptive nameNA
    D.3.9.4EV Substance CodeSUB244963
    D.3.10 Strength
    D.3.10.1Concentration unit mg/g milligram(s)/gram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Moderate-to-Severe Active Psoriatic Arthritis
    E.1.1.1Medical condition in easily understood language
    Moderate-to-Severe Active Psoriatic Arthritis
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10037160
    E.1.2Term Psoriatic arthritis
    E.1.2System Organ Class 10028395 - Musculoskeletal and connective tissue disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the efficacy of zunsemetinib in patients with moderate-to-severe PsA as measured by 20% improvement in ACR20
    E.2.2Secondary objectives of the trial
    - To assess the effect of zunsemetinib on 50% and 70% improvement in ACR response criteria (ACR 50/70) in patients with moderate-to-severe PsA;
    - To assess the effect of zunsemetinib on ACR 20/50/70 response over time in patients with moderate-to-severe PsA;
    - To assess the effect of zunsemetinib on joint tenderness in patients with moderate-to severe PsA;
    - To assess the effect of zunsemetinib on joint swelling in patients with moderate-to severe PsA;
    - To assess the effect of zunsemetinib on physical functioning/disability in patients with moderate-to-severe PsA;
    - To assess the effect of zunsemetinib on overall patient disease assessment in patients with moderate-to-severe PsA;
    - To assess the effect of zunsemetinib on overall physician disease assessment in patients with moderate-to-severe PsA;
    - To assess the effect of zunsemetinib on pain in patients with moderate-to-severe PsA as measured by Pain visual analog scale (VAS)

    Please refer to the protocol for full list.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or non-pregnant, non-breastfeeding female patients aged 18 to 75 years, inclusive, at the time of signing the informed consent form (ICF).
    2. Able to comprehend and be willing to sign the institutional review board (IRB) approved patient ICF before administration of any study-related procedures.
    3. Diagnosis of PsA with symptom onset at least 6 months before the Screening Visit and fulfilment of the Classification Criteria for PsA at the time of Screening.
    4. Patient has moderate-to-severe PsA at Screening and Randomization Visits defined as:
    o ≥3 tender joints (based on 68 joint counts) and
    o ≥3 swollen joints (based on 66 joint counts).
    5. Creatine kinase (CK) is ≤ 3 times upper limit of normal (ULN) at screening.
    6. Diagnosis of active plaque psoriasis or documented history of plaque psoriasis.
    7. Patient had an inadequate response (lack of efficacy after a minimum 12-week duration of therapy) to previous or current treatment with at least 1 non-biologic DMARD at maximally tolerated dose (MTX, sulfasalazine, leflunomide, cyclosporine, hydroxychloroquine, apremilast, bucillamine, or iguratimod), or patient has an intolerance, or contraindication for DMARDs as determined by the investigator. Note: Prior exposure to a biological or a JAK inhibitor treatment for PsA is allowed in ≤40% of study participants, but not required.
    8. Patient who is on current treatment with concomitant non-biologic DMARDs at study entry must be on ≤1 non-biologic DMARDs. The following non-biologic DMARDs are allowed: MTX, sulfasalazine, or leflunomide, and must have been ongoing for ≥12 weeks and at stable dose for ≥4 weeks prior to the Randomization Visit. No other DMARDs are permitted during the study.
    9. Anti-cyclic citrullinated peptide antibodies negative at screening.
    10. Patient is agreeable to following contraception requirements:
    o Heterosexually active female patients who are of childbearing potential must use 2 methods of highly effective contraception, 1 of which must be a physical barrier for the duration of the study and for 30 days after the last dose. If they are on a DMARD, they should follow any additional contraception guidance consistent with that product label.
    o Heterosexually active fertile male patients with a female partner of childbearing potential must agree to use a condom plus another highly effective form of birth control for the duration of the study and for 90 days after the last dose.
    11. Female patients of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test prior to dosing on Day 1.
    12. Screening laboratory evaluations (hematology, coagulation, chemistry, and urinalysis) must fall within the normal range of the central laboratory’s reference ranges unless the results have been determined by the investigator to not be clinically significant.
    E.4Principal exclusion criteria
    1. Any arthritis with onset before age 16 years, or current diagnosis of inflammatory joint disease other than PsA, or other immunological disease (including, but not limited to RA, gout, overlap connective tissue diseases, scleroderma, polymyositis, dermatomyositis, systemic lupus erythematosus).
    2. Current diagnosis of reactive arthritis or axial spondyloarthritis including ankylosing spondylitis and nonradiographic axial spondyloarthritis, is exclusionary. However, prior history of reactive arthritis or axial spondyloarthritis, including ankylosing spondylitis and nonradiographic axial spondyloarthritis, is permitted if documentation of change in diagnosis to PsA or additional diagnosis of PsA is provided, as determined by the investigator.
    3. Current diagnosis of fibromyalgia is exclusionary. However, the prior history of fibromyalgia is permitted if documentation of change in diagnosis to PsA or documentation that the diagnosis of fibromyalgia was made incorrectly incorrectly is there, as determined by the investigator.
    4. Patient has an uncontrolled non-immunoinflammatory disease that may place the patient at increased risk during the study or impact the interpretation of results, e.g., cirrhosis, previous malignancy, previous venous thromboembolism.
    5. History or evidence of active tuberculosis (TB), irrespective of prior, or current treatment status, or untreated latent TB. Note: Treated latent TB is not an exclusion.
    6. Positive QuantiFERON®-TB Gold at Screening Visit. If the QuantiFERON®-TB Gold test result is indeterminate, the test should be repeated once. Positive and Indeterminate results exclude the patient unless patient has been treated for latent tuberculosis (documented) and there is no evidence of active tuberculosis (as per investigator’s judgment).
    7. Known hypersensitivity to zunsemetinib (ATI-450) or any components of the formulation.
    8. Patient is an alcoholic, or has a history of alcoholism, alcoholic liver disease, or other chronic liver disease.
    9. Current or any recent (within last 12 months before screening) substance abuse disorder. Note: Marijuana use is allowed if not considered substance abuse by investigator. If a patient uses marijuana, patient should refrain from all marijuana use for 24 hours prior to any study site visit.
    10. Documented infection or known exposure to an individual with SARS-CoV-2 within 4 weeks before screening.
    11. A swab test positive for SARS-CoV-2 virus at screening and/or randomization visit.
    12. Active infection requiring treatment with systemic antibiotics within 4 weeks prior to randomization.
    13. Positive for HIV, hepatitis B, or C serological tests at screening. Note: Patients with hepatitis B surface antibody without the presence of hepatitis B surface antigen will be allowed to participate. Patients with positive hepatitis C antibody with undetectable hepatitis C viral load can be included in the study if they have been off hepatitis C antiviral treatment for at least 6 months before screening.
    14. Tests performed at a central laboratory at screening that meet any of the criteria defined in the protocol (out-of-range laboratory tests may be rechecked once, after consultation with the medical monitor, before patient is considered a screen failure).
    15. Any clinically significant laboratory abnormality that would affect interpretation of study data or safety of the patient’s participation in the study, per judgment of the investigator.
    16. Clinically significant abnormal findings other than PsA from PE conducted at Screening Visit (Visit 1) and at Randomization Visit (Visit 2) that may affect the interpretation of study data or the safety of the patient’s participation in the study, per the judgment of the investigator.
    17. Clinically important history of a medical disorder that would compromise patient safety or data quality, per the judgment of the investigator.
    18. Blood pressure (BP) levels (in semi-supine position after at least 5 minutes rest) <90 mm Hg or >150 mm Hg for systolic BP or <40 mm Hg or >90 mm Hg for diastolic BP at randomization.
    19. Has taken any of the following within the defined period below before randomization:
    o Cyclosporine, azathioprine apremilast, and all others oral DMARDs for PsA: 4 weeks or within 5 half-lives (whichever is longer)
    o Etanercept, anakinra: 4 weeks
    o Adalimumab, certolizumab pegol, sarilumab, tocilizumab, brodalumab: 6 weeks
    o Secukinumab, ixekizumab: 8 weeks
    o Ustekinumab, guselkumab, risankizumab, tildrakizumab: 16 weeks
    o Other biologic DMARDs (eg, infliximab, golimumab, abatacept): 12 weeks
    o JAK or TYK2 inhibitors: 4 weeks
    o Rituximab or other B cell inhibitors: 12 months
    o Investigational small molecules: 4 weeks
    o Investigational biologics: 3 months or five half-lives, whichever is longer
    o Intra-articular corticosteroid injection: 4 weeks

    Please refer to protocol for the full list.
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of patients achieving ACR20 at Week 12
    E.5.1.1Timepoint(s) of evaluation of this end point
    Please refer to the above primary end point(s) section
    E.5.2Secondary end point(s)
    - Proportion of patients with ACR 50/70 at Week 12;
    - Proportion of patients with ACR 20/50/70 response at Weeks 2, 4, 6, 8;
    - Change from baseline in tender joint count (TJC) 68 at Weeks 1, 2, 4, 6, 8, 12;
    - Change from baseline in swollen joint count (SJC) 66 at Weeks 1, 2, 4, 8, 12;
    - Change from baseline in HAQ-DI at Weeks 2, 4, 8, 12;
    - Change from baseline in patient’s global assessment of disease activity (PtGA) at Weeks 2, 4, 8, 12;
    - Change from baseline in physician's global assessment of disease activity (PhGA) at Weeks 2, 4, 8, 12;
    - Change from baseline in Patients Pain VAS assessment at Weeks 2, 4, 8, 12

    Please refer to the protocol for full list.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Please refer to the above secondary end point(s) section
    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 No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Tolerability
    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 concerned12
    E.8.5The trial involves multiple Member States No
    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
    United States
    Poland
    E.8.7Trial has a data monitoring committee No
    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
    The end of the study is defined as the date of the last visit or date of last procedure of the last patient in the study.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days4
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months20
    E.8.9.2In all countries concerned by the trial days18
    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: 66
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 4
    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 state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 50
    F.4.2.2In the whole clinical trial 70
    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)
    None
    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 Decision2022-10-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-07-26
    P. End of Trial
    P.End of Trial StatusOngoing
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