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    Summary
    EudraCT Number:2020-004964-25
    Sponsor's Protocol Code Number:ABY-035-203
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2021-02-25
    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 number2020-004964-25
    A.3Full title of the trial
    A phase 2 trial of the efficacy and safety of the interleukin-17A inhibitor ABY-035 in
    the treatment and prevention of relapse/recurrence of non-infectious intermediate,
    posterior or pan-uveitis (LINNAEA)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Multinational, multicenter, phase 2 study of the efficacy and safety of ABY-035 in treating and preventing relapse/recurrence of disease activity in subjects with non-infectious intermediate, posterior or pan-uveitis.
    A.3.2Name or abbreviated title of the trial where available
    LINNAEA
    A.4.1Sponsor's protocol code numberABY-035-203
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04706741
    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 SponsorAffibody AB
    B.1.3.4CountrySweden
    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 supportAffibody AB
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAffibody AB
    B.5.2Functional name of contact pointRegulatory Affairs
    B.5.3 Address:
    B.5.3.1Street AddressScheeles väg 2
    B.5.3.2Town/ citySolna
    B.5.3.3Post codeSE-171 65
    B.5.3.4CountrySweden
    B.5.4Telephone number+46 (0) 763495849
    B.5.5Fax number+46 8 59 88 38 01
    B.5.6E-mailcamilla.sandell@affibody.se
    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 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    non-infectious intermediate, posterior, or pan-uveitis
    E.1.1.1Medical condition in easily understood language
    non-infectious intermediate, posterior, or pan-uveitis
    E.1.1.2Therapeutic area Diseases [C] - Eye Diseases [C11]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10046851
    E.1.2Term Uveitis
    E.1.2System Organ Class 10015919 - Eye disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Primary objective:
    To evaluate the efficacy of ABY-035 in treating active uveitis from Baseline (BL) up to week 10 (W10).
    E.2.2Secondary objectives of the trial
    • To evaluate the efficacy of ABY-035 in preventing relapse/recurrence in inactive uveitis beyond W10 up to W50
    • To evaluate the safety of ABY-035
    • To characterize the exposure of ABY-035 in plasma
    • To assess the immunogenicity of ABY-035 as measured by the presence of anti-drug antibodies (ADA)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1] Signed informed consent and signed data protection declaration
    2] ≥18 years of age at SCR
    3] Previously documented medical history with diagnosed unilateral or bilateral NIIPPU
    4] Active disease at BL defined by the presence of at least 1 of the following criteria in at least one eye
    despite treatment with stable doses of corticosteroids for at least 2 weeks:
    a) Active, inflammatory, chorioretinal and/or inflammatory retinal vascular lesion by Dilated
    Indirect Ophthalmoscopy (DIO),Fundus Photography, and Fluorescein angiography (FA) Spectral-Domain Optical Coherence Tomography (SD-OCT) to
    determine whether a lesion is active or inactive (the central reader’s assessment using FA and/or Fundus Photography and/or SD-OCT is required to confirm eligibility).
    b) ≥2+ vitreous haze ( NEI/SUN criteria) by DIO and Fundus Photography (the central reader’s
    assessment using Fundus Photography is required to confirm eligibility).
    5] On treatment with oral corticosteroids (≥7 to ≤40 mg/day oral prednisolone/pre dnisone or
    equivalent) at a stable dose for at least 2 weeks before BL
    6] For females of non-childbearing potential: Post-menopausal or surgically sterile
    7] For females of childbearing potential: Negative human chorionic gonadotropin (hCG) test at SCR
    visit AND practicing adequate contraception (see section 7.1.7) from SCR to FU PK/ADA/preg (section 6.2.6)
    8] For males: if having a female partner, the partner should be of non-childbearing potential (see
    inclusion criteria 6) OR using an adequate method of contraception (see section 7.1.7) from SCR to
    FU PK/ADA/preg (see 6.2.6)
    9] Able and willing to comply with the trial directives (as per the investigator's judgment)
    E.4Principal exclusion criteria
    1] History of hypersensitivity or allergy to ABY-035 or its excipients
    2] History of hypersensitivity or allergy to fluorescein dye
    3] Previous enrollment or randomization in the trial
    4] Participation in another interventional clinical trial within 30 days before SCR or administration of
    another IMP within 5 half-lives (for experimental biologics: 6 months or 5 half-lives, whichever is
    longer) before BL
    5] Evidence or suspicion of social drug and/or alcohol abuse or dependence, according to the judgment
    of the investigator
    6] Females who are currently pregnant, who intend to become pregnant during the trial, or who are
    breastfeeding
    7] The subject is an investigator or belongs to the personnel of the trial site, the sponsor or involved
    service providers and/or their immediate families (partner, spouse, parent, child, or sibling, whether
    biological or legally adopted)
    8] Subject with any medical or psychiatric condition which, in the investigator's opinion, would
    preclude the subject from adhering to the protocol or completing the clinical trial per protocol
    9] The subject is considered to belong to a vulnerable population (e.g. placed under guardianship,
    imprisoned, other)
    Criteria that relate to ocular conditions (and the etiology thereof)
    10] Subject with isolated anterior uveitis
    11] Subject with Occlusive Behçet's disease, Acute Posterior Multifocal Placoid Pigment
    Epitheliopathy, Acute Posterior Pigment Epithelitis, Multiple Evanescent White Dot Syndrome,
    Punctate Inner Choroiditis or serpiginous choroidopathy
    12] Subject with confirmed or suspected infectious uveitis, including but not limited to infectious uveitis
    due to TB, syphilis, cytomegalovirus, Lyme disease, toxoplasmosis, Human T-Lymphotropic Virus
    Type 1 infection, Whipple's disease, herpes zoster virus, and herpes simplex virus
    13] Subject with corneal or lens opacity that precludes visualization of the fundus or that likely requires
    cataract surgery during the duration of the trial
    14] Planned (elective) eye surgery within 80 weeks after BL
    15] History of prior refractive laser surgery, retinal laser photocoagulation, or neodymium-doped
    yttrium aluminium garnet posterior capsulotomy within 30 days before BL
    16] History of any other prior ocular surgery within 90 days before BL
    17] Subject with intraocular pressure (IOP) of ≥25 mmHg while on ≥2 glaucoma medications or
    evidence of glaucomatous optic nerve injury
    18] Subject with severe vitreous haze that precludes visualization of the fundus at BL
    19] Subject has a contraindication for mydriatic eye drops OR subject cannot be dilatated sufficiently
    well to permit good fundus visualization
    20] Subject with BCVA <20 letters (ETDRS) in at least one eye at BL
    21] Subject with intermediate uveitis or panuveitis who has presence or history of whitish exudates on
    the inferior pars plana (snowbanking) or vitreal inflammatory aggregates (snowballs) in combination
    with a medical history or signs or symptoms suggestive of a demyelinating disease such as multiple
    sclerosis
    22] Subject with proliferative or severe non-proliferative diabetic retinopathy or clinically significant
    macular edema due to diabetic retinopathy
    23] Subject with neovascular/wet age-related macular degeneration
    24] Subject with an abnormality of the vitreo-retinal interface (i.e., vitreomacular traction, epiretinal
    membranes, etc.) with the potential for macular structural damage independent of the inflammatory
    process
    25] Subject with a history of active scleritis within 12 months of SCR
    Criteria that relate to comorbidity
    26] Uncontrolled inflammatory bowel disease
    27] Infection requiring treatment with IV anti-infectives within 30 days before BL or oral anti-infectives
    within 14 days before BL
    28] Subject with any active infection that based on the investigator's clinical assessment makes the
    subject an unsuitable candidate for the trial
    29] History or any signs of lymphoproliferative disease, or a known malignancy or a history of
    malignancy within the previous 3 years (except for basal cell or squamous cell carcinoma of the skin
    that had been fully excised with no evidence of recurrence)
    E.5 End points
    E.5.1Primary end point(s)
    Primary: The number and proportion of subjects with Complete Response at W10
    E.5.1.1Timepoint(s) of evaluation of this end point
    W10
    E.5.2Secondary end point(s)
    Secondary endpoints (Efficacy) supporting the primary objective related to the treatment of active disease (≤W10):
    •Change in ACC grade from BL to W10 or to discontinuation of IMP, if earlier
    •Change in vitreous haze grade (NEI/SUN criteria) from BL to W10 or to discontinuation of IMP, if earlier
    •Change in BCVA using logMAR calculation from BL to W10 or to discontinuation of IMP, if earlier
    •Change in central retinal thickness (by SD-OCT) from BL to W10 or to discontinuation of IMP, if earlier
    •Change in excess CST from BL to W10 or to discontinuation of IMP, if earlier
    •Change in the NEI VFQ-25 score from BL to W10 or to discontinuation of IMP, if earlier
    •Change in the EQ-5D-3L questionnaire score from BL to W10 or to discontinuation of IMP, if earlier

    Time to Treatment Failure (TTF) (beyond W10) for the preventive phase is set as the secondary efficacy criterion. At any visit beyond W10 (including unscheduled visits if applicable), "Treatment Failure" is defined as Y/N by visit by meeting at least 1 of the following criteria in at least one eye (please see protocol section 2.2 Trial Endpoints).
    E.5.2.1Timepoint(s) of evaluation of this end point
    • Secondary endpoints related to the treatment of active disease: BL to W10
    • Other Secondary Endpoints related to the preventive phase: beyond W10
    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 Yes
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    immunogenicity of ABY-035
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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 No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA10
    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
    Austria
    Germany
    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
    Last Subject Last Visit (LSLV)
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    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: 18
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 2
    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 state8
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 10
    F.4.2.2In the whole clinical trial 20
    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)
    When subjects complete the study, continuing treatment according to clinical routine will be provided as judged by the Investigator or treating physician.
    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 Decision2021-05-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-04-07
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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