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    Summary
    EudraCT Number:2022-001686-12
    Sponsor's Protocol Code Number:20210210
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-11-18
    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 ConcernedAustria - BASG
    A.2EudraCT number2022-001686-12
    A.3Full title of the trial
    A Phase 2 Long-Term Extension (LTE) Study to Evaluate The Safety and Efficacy of Efavaleukin Alfa in Subjects with Moderately to Severely Active Ulcerative Colitis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Long-term Safety and Efficacy of Efavaleukin Alfa in Subjects With Moderately to Severely Active Ulcerative Colitis
    A.4.1Sponsor's protocol code number20210210
    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 SponsorAmgen 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 supportAmgen Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAmgen GmbH
    B.5.2Functional name of contact pointMedical Information
    B.5.3 Address:
    B.5.3.1Street AddressFranz-Josefs-Kai 47
    B.5.3.2Town/ cityWien
    B.5.3.3Post code1010
    B.5.3.4CountryAustria
    B.5.4Telephone number+43150217
    B.5.6E-mailmedinfo-at@amgen.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 nameEfavaleukin Alfa
    D.3.2Product code AMG 592
    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 INNEfavaleukin alfa
    D.3.9.2Current sponsor codeAMG 592
    D.3.9.4EV Substance CodeSUB195522
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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
    Moderate to Severe Active Ulcerative Colitis (UC)
    E.1.1.1Medical condition in easily understood language
    Ulcerative Colitis (UC)
    E.1.1.2Therapeutic area Body processes [G] - Immune system processes [G12]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10045365
    E.1.2Term Ulcerative colitis
    E.1.2System Organ Class 10017947 - Gastrointestinal 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 evaluate the long-term safety and tolerability of efavaleukin alfa in subjects with moderate to severe ulcerative colitis (UC)
    E.2.2Secondary objectives of the trial
    - To evaluate the effect of efavaleukin alfa long-term treatment on clinical response
    - To evaluate the effect of efavaleukin alfa long-term treatment on clinical remission
    - To evaluate the effect of efavaleukin alfa long-term treatment on durable clinical remission
    - To evaluate the effect of efavaleukin alfa long-term treatment on endoscopic remission
    - To evaluate the effect of efavaleukin alfa long-term treatment on histologic remission
    - To evaluate the effect of efavaleukin alfa long-term treatment on corticosteroid-free remission
    - To evaluate the effect of efavaleukin alfa long-term treatment on combined endoscopic and histologic remission
    - To evaluate the effect of efavaleukin alfa long-term treatment on symptomatic remission
    - To evaluate the effect of efavaleukin alfa long-term treatment on change in histological score
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    101 Subject has provided informed consent prior to initiation of any study specific activities/procedures.
    102 Subject has completed the week 52 endoscopy in the phase 2 parent dose finding study (20170104) and who in the opinion of the investigator may benefit from continued treatment.
    E.4Principal exclusion criteria
    201 Permanent discontinuation of investigational product during the 52-week phase 2 dose finding study (20170104) for any reason.

    Disease Related
    202 Adenoma and dysplasia exclusion criteria:
    - Any current sporadic adenoma without dysplasia (adenomatous polyps occurring proximal to known areas of colitis) that has not been removed.
    - Dysplasia occurring in flat mucosa, sporadic adenomas containing dysplasia, and dysplasia-associated lesions or masses will be managed as follows:
    1. Any history or current evidence of high-grade dysplasia.
    2. Any history or current evidence of dysplasia occurring in flat mucosa. This includes histopathology reporting indefinite for dysplasia, low-grade dysplasia, and high-grade dysplasia.
    3. Any history or current evidence of a non-adenoma like dysplasia associated lesions or masses, with or without evidence of dysplasia.
    4. Any current sporadic adenoma containing dysplasia or any current adenoma-like dysplasia-associated lesions or masses that has not been
    removed.

    Other Medical Conditions
    203 Any malignancy diagnosed during Study 20170104, including evidence of cutaneous basal or squamous cell carcinoma or melanoma
    204 Active infection (including chronic, acute, recurrent, opportunistic infections) at the time of eligibility evaluation requiring intravenous (IV) anti-infectives or hospitalization (infections requiring oral and/or topical anti-infective[s] for > 7 days may be allowed in consultation with the Amgen physician).
    205 Required systemic corticosteroid use for any indication other than UC. The only exception is corticosteroids used for the treatment of adrenal insufficiency are allowed.

    Prior/Concomitant Therapy
    206 Plan to receive a live (attenuated) vaccine during the treatment period and up to 6 weeks after the last dose of investigational product in the LTE study.

    Prior/Concurrent Clinical Study Experience
    207 Currently receiving treatment in another investigational device or drug study. Other investigational procedures while participating in this study are excluded.

    Other Exclusions
    208 Female subjects who are pregnant or breastfeeding or planning to become pregnant or breastfeed during study and for an additional 6 weeks after the last dose of investigational product.
    209 Female subjects of childbearing potential unwilling to use protocol specified method of contraception see Appendix 5 (Section 11.5) during treatment and for an additional 6 weeks after the last dose of investigational product.
    210 Subject has known sensitivity to any of the products to be administered during dosing with the exception of subjects who exhibited sensitivity in Study 20170104 but did not result in treatment discontinuation.
    211 Subject likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures (e.g., Clinical Outcome Assessments) to the best of the subject and investigator’s knowledge.
    212 Subject has a history or evidence of any other clinically significant disorder (including laboratory abnormalities), condition, or disease that, in the opinion of the investigator or Amgen physician, if consulted would pose a risk to subject safety, or interfere with the study evaluation, procedures, or completion.
    214 Female subjects of reproductive potential must agree not to donate eggs during the study and for 6 weeks after receiving the last dose of investigational product.
    E.5 End points
    E.5.1Primary end point(s)
    Treatment-emergent adverse events
    E.5.1.1Timepoint(s) of evaluation of this end point
    Throughout the study
    E.5.2Secondary end point(s)
    - Clinical response at week 52 and 104
    - Clinical remission at week 52 and 104
    - Durable clinical remission at week 52 and 104
    - Endoscopic remission at week 52 and 104
    - Histologic remission at week 52 and 104
    - Corticosteroid-free remission at week 52 and 104 in subjects receiving Corticosteroid receiving corticosteroids at randomization of the phase 2 parent study (Study 20170104)
    - Combined endoscopic and histologic remission at week 52 and 104
    - Symptomatic remission at week 52 and 104
    - Change from baseline of Study 20170104 in histological score (Geboes) at week 52 and 104
    E.5.2.1Timepoint(s) of evaluation of this end point
    Weeks 52 and 104
    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 No
    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 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 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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA64
    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
    Argentina
    Switzerland
    Taiwan
    Canada
    Japan
    Korea, Republic of
    Mexico
    United States
    Austria
    Belgium
    Bulgaria
    Czechia
    Denmark
    Finland
    France
    Germany
    Greece
    Hungary
    Italy
    Latvia
    Netherlands
    Poland
    Romania
    Slovakia
    Spain
    Türkiye
    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
    The end of study date is defined as the date when the last subject across all sites is assessed or receives an intervention for evaluation in the study (ie, last subject last visit), including any additional parts in the study (eg, long-term follow-up, antibody testing), as applicable.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months1
    E.8.9.1In the Member State concerned days4
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months1
    E.8.9.2In all countries concerned by the trial days4
    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: 94
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 46
    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 state6
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 70
    F.4.2.2In the whole clinical trial 140
    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)
    After last patient last visit an individual subject will enter in a safety follow-up of 6 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 Decision2023-01-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2023-07-05
    P. End of Trial
    P.End of Trial StatusOngoing
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