Long-term Safety and Efficacy of Efavaleukin Alfa in Participants With Moderately to Severely Active Ulcerative Colitis
NCT ID: NCT05672199
Last Updated: 2025-10-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
25 participants
INTERVENTIONAL
2023-04-28
2024-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Placebo
Participants who were receiving the placebo during the dose-finding study (study 20170104) that decided to continue onto this long-term extension study will continue to receive the placebo.
Placebo
SC injection
Efavaleukin Alfa Dose 1 (Low Dose)
Participants who were receiving efavaleukin alfa dose 1 during the dose-finding study (study 20170104) that decided to continue onto this long-term extension study will continue to receive efavaleukin alfa dose 1.
Efavaleukin alfa
Subcutaneous (SC) injection
Efavaleukin Alfa Dose 2 (Moderate Dose)
Participants who were receiving efavaleukin alfa dose 2 during the dose-finding study (study 20170104) that decided to continue onto this long-term extension study will continue to receive efavaleukin alfa dose 2.
Efavaleukin alfa
Subcutaneous (SC) injection
Efavaleukin Alfa Dose 3 (High Dose)
Participants who were receiving efavaleukin alfa dose 3 during the dose-finding study (study 20170104) that decided to continue onto this long-term extension study will continue to receive efavaleukin alfa dose 3.
Efavaleukin alfa
Subcutaneous (SC) injection
Interventions
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Efavaleukin alfa
Subcutaneous (SC) injection
Placebo
SC injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Participant has completed the week 52 endoscopy in the phase 2 dose-finding parent study (20170104) and who in the opinion of the investigator may benefit from continued treatment.
Exclusion Criteria
* 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.
Disease Related:
* 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:
* Any history or current evidence of high-grade dysplasia.
* 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.
* Any history or current evidence of a nonadenoma like dysplasia associated lesions or masses, with or without evidence of dysplasia.
* Any current sporadic adenoma containing dysplasia or any current adenoma-like dysplasia-associated lesions or masses that has not been removed.
Other Medical Conditions:
* Any malignancy diagnosed during parent Study 20170104, including evidence of cutaneous basal or squamous cell carcinoma or melanoma
* 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).
* Required systemic corticosteroid use for any indication other than ulcerative colitis. The only exception is corticosteroids used for the treatment of adrenal insufficiency are allowed.
* 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 long term extension study.
Prior/Concurrent Clinical Study Experience:
* Currently receiving treatment in another investigational device or drug study. Other investigational procedures while participating in this study are excluded.
Other Exclusions:
* Female participants 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.
* Female participants 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.
* Participant has known sensitivity to any of the products to be administered during dosing with the exception of participants who exhibited sensitivity in parent Study 20170104 but did not result in treatment discontinuation.
* Participant 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 participant and investigator's knowledge.
* Participant 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 participant safety, or interfere with the study evaluation, procedures, or completion.
18 Years
80 Years
ALL
No
Sponsors
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Amgen
INDUSTRY
Responsible Party
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Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
Locations
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Santa Maria Gastroenterology Medical Group
Santa Maria, California, United States
Indian Health Service Health Research
Kissimmee, Florida, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
Centro de Investigaciones Medicas Mar del Plata
Mar del Plata, Buenos Aires, Argentina
Clinica Independencia
Munro, Buenos Aires, Argentina
Cer Instituto Medico
Quilmes, Buenos Aires, Argentina
Diagnostic-Consultative Center Convex EOOD
Sofia, , Bulgaria
Herlev Hospital
Herlev, , Denmark
Universitaetsklinikum Ulm
Ulm, , Germany
MIND Klinika Kft
Budapest, , Hungary
Clinexpert Kft
Budapest, , Hungary
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont Altalanos Orvostudomanyi Kar
Szeged, , Hungary
Tsujinaka Hospital Kashiwanoha
Kashiwa-shi, Chiba, Japan
Nagasaki University Hospital
Nagasaki, Nagasaki, Japan
Ome Medical Center
Ome-shi, Tokyo, Japan
Clinica de Investigacion en Reumatologia y Obesidad SC
Guadalajra, Jalisco, Mexico
NZOZ Twoje Zdrowie EL Spzoo
Elblag, , Poland
Centrum Medyczne Melita Medical
Wroclaw-Krzyki, , Poland
Clinica Medicum
Bucharest, , Romania
Memorial Healthcare International SRL
Bucharest, , Romania
Spitalul Clinic Colentina
Bucharest, , Romania
Wonju Severance Christian Hospital
Wonju-si, Gangwon-do, , South Korea
Intesto BE
Bern, , Switzerland
Kocaeli Universitesi Tip Fakultesi Hastanesi
Kocaeli, , Turkey (Türkiye)
Mersin Universitesi Tip Fakultesi Hastanesi
Mersin, , Turkey (Türkiye)
Countries
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Related Links
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AmgenTrials clinical trials website
Other Identifiers
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2022-001686-12
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
20210210
Identifier Type: -
Identifier Source: org_study_id
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