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    Summary
    EudraCT Number:2021-005713-13
    Sponsor's Protocol Code Number:21102
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2022-04-19
    Trial results View 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 - BfArM
    A.2EudraCT number2021-005713-13
    A.3Full title of the trial
    A Phase 2b Pivotal Study to Evaluate the Efficacy and Safety of Izokibep in Subjects with Moderate to Severe Hidradenitis Suppurativa
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Evaluate the Efficacy and Safety of Izokibep in Subjects with Moderate to Severe Hidradenitis Suppurativa
    A.4.1Sponsor's protocol code number21102
    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 SponsorACELYRIN, 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 supportACELYRIN, INC.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationACELYRIN, INC.
    B.5.2Functional name of contact pointClinical Trial Information Desk
    B.5.3 Address:
    B.5.3.1Street Address4149 Liberty Canyon Rd
    B.5.3.2Town/ cityAgoura Hills
    B.5.3.3Post codeCA 91301
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1-805-456-4393
    B.5.6E-mailclinicaltrials@acelyrin.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 nameIzokibep
    D.3.2Product code ABY-035
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNIzokibep
    D.3.9.1CAS number 2226130-02-3
    D.3.9.2Current sponsor codeABY-035
    D.3.9.3Other descriptive nameRecombinant protein comprising two IL-17A binding domains and an albumin binding domain
    D.3.9.4EV Substance CodeSUB201240
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number80
    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 Yes
    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 injection
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Hidradenitis Suppurativa
    E.1.1.1Medical condition in easily understood language
    Hidradenitis Suppurativa
    E.1.1.2Therapeutic area Diseases [C] - Skin and Connective Tissue Diseases [C17]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 27.1
    E.1.2Level LLT
    E.1.2Classification code 10020041
    E.1.2Term Hidradenitis suppurativa
    E.1.2System Organ Class 10040785 - Skin and subcutaneous tissue disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Part A
    - To explore the efficacy of izokibep as measured by HiSCR75 at Week 12
    Part B
    - To demonstrate that one or both treatment regimens of izokibep is efficacious compared to placebo, as measured by HiSCR75 at Week 16
    E.2.2Secondary objectives of the trial
    Part A
    -Explore the safety & tolerability
    -Explore the immunogenicity of izokibep as measured by the presence of ADAs
    Part B
    -Demonstrate that one or both regimens of izokibep is efficacious, as measured by:
    •Percentage of subjects achieving HiSCR90 at Week 16
    •Percentage of subjects achieving HiSCR100 at Week 16
    •Percentage of subjects achieving HiSCR50 at Week 16
    •Percentage of subjects that experience ≥ 1 disease flare through 16 weeks of treatment
    •Percentage of subjects with baseline Hurley Stage II who achieve AN count of 0, 1, or 2 at Week 16
    • Percentage of subjects achieving at least 3 point reduction from baseline in NRS in Patient Global Assessment of Skin Pain at its worst at Week 16 among participants with baseline NRS ≥4
    -Assess the safety and tolerability of izokibep as measured by the incidence of TEAEs, events of interest, SAEs, and clin. significant laboratory values and vital signs
    -Assess the immunogenicity of izokibep as measured by the presence of ADAs
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Subject (male and female) must be ≥ 18 and ≤ 75 years
    - Diagnosis of HS for ≥ 1 year
    - HS lesions present in ≥ 2 distinct anatomic areas, one of Hurley Stage II
    or Hurley Stage III
    - A total AN count of ≥ 5 at screening
    - Subject must have had an inadequate response to oral antibiotics (defined as ≥ 3-month treatment with an oral antibiotic for treatment of HS) OR exhibited recurrence after discontinuation to, OR demonstrated intolerance to, OR have a contraindication to oral antibiotics for treatment of their HS
    - Subject must agree to use daily (throughout the duration of the study) one of the following over-the-counter topical antiseptics on their body areas affected with HS suppurativa lesions: chlorhexidine gluconate, triclosan, benzoyl peroxide, or diluted bleach in bathwater.
    - Subject must be willing to complete a daily skin pain diary 7 consecutive days prior to Day 1
    - No known history of active tuberculosis
    - Subject has a negative tuberculosis test at screening
    - Male and Female participants of childbearing potential must use effective methods of contraception

    For a complete overview of the inclusion criteria refer to the protocol.
    E.4Principal exclusion criteria
    - Draining fistula count of > 20 at screening or Day 1 prior to enrollment/randomization
    - Outpatient surgery ≤ 8 weeks prior or inpatient surgery ≤ 12 weeks prior to enrollment/randomization
    - Other active skin disease or condition (eg, bacterial, fungal or viral infection) that could interfere with study assessments
    - Active inflammatory bowel disease (IBD) within 3 years prior to enrollment
    - Chronic pain not associated with HS (eg, fibromyalgia).
    - Uncontrolled, clinically significant system disease such as diabetes mellitus, cardiovascular disease including moderate to severe heart failure (New York Heart Association class III/IV), moderate to severe renal disease, moderate to severe liver disease or hypertension
    - History of demyelinating disease (including myelitis) or neurological symptoms suggestive of demyelinating disease
    - Malignancy within 5 years except treated and considered cured cutaneous squamous or basal cell carcinoma, in situ cervical cancer, or in situ breast ductal carcinoma
    - The subject is at risk of self-harm or harm to others as evidenced by past suicidal behavior or endorsing items 4 or 5 on the Columbia-Suicide Severity Rating Scale (C-SSRS) assessed at screening. Subjects with major depressive disorder are permitted in the study if they are considered by the investigator to be stable and are taking no more than 1 medication. Subjects must have been on a stable dose within the 3 months prior to the first dose of study drug
    - History or evidence of any clinically significant disorder (including psychiatric), condition, or disease that, in the opinion of the Investigator, may pose a risk to subject safety or interfere with the study evaluation, procedures, or completion
    - Any active infection for which oral anti-infectives (antibiotics, antivirals, antifungals) were used ≤ 14 days prior to first dose of study drug (except for the use of a stable dose allowable antibiotics [doxycycline or minocycline only] for HS)
    - A serious infection requiring hospitalization or IV anti-infectives (antibiotics, antivirals, antifungals) ≤ 30 days prior to first dose of study drug
    - Recurrent or chronic infections or other active infections that in the opinion of the investigator might cause this study to be detrimental to the subject
    - Candida infection requiring systemic treatment ≤ 3 months prior to first dose of study drug
    - Tuberculosis or fungal infection seen on available chest x-ray taken ≤ 3 months of screening or at screening
    - Known history of human immunodeficiency virus (HIV)
    - Previous exposure to izokibep or any other IL-17 receptor inhibitors (eg, secukinumab, ixekizumab, bimekizumab, brodalumab)
    - Prior exposure to biologics that have a potential for or known association with progressive multifocal leukoencephalopathy (ie, natalizumab [Tysabri ®], rituximab [Rituxan®], or efalizumab [Raptiva®])
    - Exposure to TNF-α inhibitors, IL-1, IL-12, IL-23, or IL-12/23 receptor inhibitors within 5 half-lives prior to first dose of study drug
    - Exposure to the following ≤ 12 weeks prior to first dose of study drug
    • Other experimental or commercially available biologic or biosimilar therapies (within 12 weeks or 5 half-lives, whichever is longer)
    • IV gamma-globulin or Prosorba column therapy
    • Exposure to the following ≤ 4 weeks prior to first dose of study drug
    • JAK inhibitors (eg, tofacitinib, upadacitinib)
    • Oral or injectable corticosteroids (including intralesional injections)
    • Cyclosporine, azathioprine, tacrolimus
    • Other systemic treatments for autoimmune/inflammatory conditions not listed above or below (eg, mycophenolate mofetil, retinoids, fumarates, apremilast, or phototherapy [eg, PUVA, UVA, UVB]), except for allowable stable dose antibiotics (doxycycline or minocycline)
    • Laser or intense pulse light therapy in anatomic areas of HS lesions
    - For subjects entering study with a permitted oral antibiotic treatment (doxycycline or minocycline only) for HS: not on a stable dose for ≥ 4 weeks prior to first dose of study drug
    - For subjects entering study with oral, non-opioid analgesics: not on a stable dose for ≥5 days prior to first dose of study drug
    - Required or is expected to require, opioid analgesics for any reason (excluding tramadol) during the study
    - Received live vaccination ≤ 12 weeks prior to dosing or scheduled to receive a live vaccine ≤ 12 weeks following the last dose of study drug
    - Positive hepatitis B surface antigen (HBsAg) or detected sensitivity on the hepatitis B virus DNA polymerase chain reaction (PCR) qualitative test for hepatitis B core antibodies (HBcAB)/Hepatitis B surface antibodies (HBsAb) positive subjects OR positive Hepatitis C virus antibody test at screening
    - Laboratory abnormalities at screening as described

    For a complete overview of the exclusion criteria refer to the protocol.
    E.5 End points
    E.5.1Primary end point(s)
    Part A
    HiSCR75 = hidradenitis suppurativa clinical response at week 12
    Part B
    HiSCR75 at week 16
    E.5.1.1Timepoint(s) of evaluation of this end point
    Part A
    HiSCR75 - at Week 12
    Part B
    HiSCR75 - at Week 16
    E.5.2Secondary end point(s)
    Part A
    - TEAEs and SAEs
    - Laboratory values and vital signs at collected timepoints
    - ADAs (= anti-drug antibodies)
    Part B
    - HiSCR90 at Week 16
    - HiSCR100 at Week 16
    - HiSCR50 at Week 16
    - HS flares through Week 16

    - AN count of 0, 1, or 2 at Week 16
    - NRS30 in Patient Global Assessment of Skin Pain at its worst at Week 16
    - TEAEs, events of interest, and SAEs
    - Laboratory values and vital signs at collected timepoints
    -ADAs
    E.5.2.1Timepoint(s) of evaluation of this end point
    Part A and Part B
    - TEAEs and SAEs events of interest
    - Laboratory values and vital signs at collected timepoints
    - ADAs (= anti-drug antibodies)
    From start of treatment to end of study.

    - HiSCR90 at Week 16
    - HiSCR100 at Week 16
    - HiSCR50 at Week 16
    - HS flares through Week 16
    - AN count of 0, 1, or 2 at Week 16
    - NRS30 in Patient Global Assessment of Skin Pain at its worst at Week 16
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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
    Immunogenecity
    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 Yes
    E.8.1.7.1Other trial design description
    Part A proof-of-concept, single-arm, open-label part
    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 trial4
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA25
    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
    Canada
    United States
    Germany
    Hungary
    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
    LVLS
    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 days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months2
    E.8.9.2In all countries concerned by the trial days0
    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: 202
    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 state28
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 98
    F.4.2.2In the whole clinical trial 206
    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)
    There is no plan to continue access to study intervention after the end of study. The choice of further therapy for HS at the end of the clinical trial depends on the patient's individual needs and is left at the physician's discretion, based on available therapies approved for such use.
    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 Decision2022-08-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-08-16
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2024-02-21
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