Long-term Safety and Efficacy of Efavaleukin Alfa in Participants With Moderately to Severely Active Ulcerative Colitis

NCT05672199 | Terminated Phase 2 DMC FDA Drug

• 2 other identifiers: 202102102022-001686-12
• Study Type: interventional
• Target: 25
• Locations: 13 countries
• Sites: 25

Brief Summary

The primary objective of this study is to evaluate the long-term safety and tolerability of efavaleukin alfa in participants with moderate to severe ulcerative colitis (UC).

Conditions

Ulcerative Colitis

Keywords

Ulcerative colitis; UC; Moderately to severely active ulcerative colitis; Efavaleukin alfa; AMG 592

Outcome Measures

Primary Outcomes (1)

• Number of Participants with Treatment-emergent Adverse Events (TEAEs)

  Day 1 to Week 110

Secondary Outcomes (18)

• Number of Participants with Clinical Response at Week 52

  Week 52

• Number of Participants with Clinical Response at Week 104

  Week 104

• Number of Participants with Clinical Remission at Week 52

  Week 52

• Number of Participants with Clinical Remission at Week 104

  Week 104

• Number of Participants with Durable Clinical Remission at Week 52

  Week 52

Study Arms (4)

Placebo

PLACEBO COMPARATOR

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.

Drug: Placebo

Efavaleukin Alfa Dose 1 (Low Dose)

EXPERIMENTAL

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.

Drug: Efavaleukin alfa

Efavaleukin Alfa Dose 2 (Moderate Dose)

EXPERIMENTAL

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.

Drug: Efavaleukin alfa

Efavaleukin Alfa Dose 3 (High Dose)

EXPERIMENTAL

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.

Drug: Efavaleukin alfa

Interventions

Efavaleukin alfa DRUG

Subcutaneous (SC) injection

Also known as: AMG 592

Efavaleukin Alfa Dose 1 (Low Dose); Efavaleukin Alfa Dose 2 (Moderate Dose); Efavaleukin Alfa Dose 3 (High Dose)

Placebo DRUG

SC injection

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant has provided informed consent prior to initiation of any study specific activities/procedures.
• 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.

You may not qualify if:

• Permanent discontinuation of investigational product during the 52- week phase 2 dose finding parent study (20170104) for any reason
• 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.

Sponsors & Collaborators

• Amgen: lead

Study Sites (25)

Santa Maria Gastroenterology Medical Group

Santa Maria, California, 93458, United States

Location

Indian Health Service Health Research

Kissimmee, Florida, 34741, United States

Location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Centro de Investigaciones Medicas Mar del Plata

Mar del Plata, Buenos Aires, B7600DHK, Argentina

Location

Clinica Independencia

Munro, Buenos Aires, 1605, Argentina

Location

Cer Instituto Medico

Quilmes, Buenos Aires, B1878DVB, Argentina

Location

Diagnostic-Consultative Center Convex EOOD

Sofia, 1680, Bulgaria

Location

Herlev Hospital

Herlev, 2730, Denmark

Location

Universitaetsklinikum Ulm

Ulm, 89081, Germany

Location

MIND Klinika Kft

Budapest, 1024, Hungary

Location

Clinexpert Kft

Budapest, 1033, Hungary

Location

Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont Altalanos Orvostudomanyi Kar

Szeged, 6725, Hungary

Location

Tsujinaka Hospital Kashiwanoha

Kashiwa-shi, Chiba, 277-0871, Japan

Location

Nagasaki University Hospital

Nagasaki, Nagasaki, 852-8501, Japan

Location

Ome Medical Center

Ome-shi, Tokyo, 198-0042, Japan

Location

Clinica de Investigacion en Reumatologia y Obesidad SC

Guadalajra, Jalisco, 44650, Mexico

Location

NZOZ Twoje Zdrowie EL Spzoo

Elblag, 82-300, Poland

Location

Centrum Medyczne Melita Medical

Wroclaw-Krzyki, 50-449, Poland

Location

Clinica Medicum

Bucharest, 012015, Romania

Location

Memorial Healthcare International SRL

Bucharest, 013812, Romania

Location

Spitalul Clinic Colentina

Bucharest, 020125, Romania

Location

Wonju Severance Christian Hospital

Wonju-si, Gangwon-do, 26426, South Korea

Location

Intesto BE

Bern, 3012, Switzerland

Location

Kocaeli Universitesi Tip Fakultesi Hastanesi

Kocaeli, 41001, Turkey (Türkiye)

Location

Mersin Universitesi Tip Fakultesi Hastanesi

Mersin, 33343, Turkey (Türkiye)

Location

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2023
• First Posted: January 5, 2023
• Study Start: April 28, 2023
• Primary Completion: October 31, 2024
• Study Completion: October 31, 2024
• Last Updated: October 15, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
• Access Criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.

Locations

US (3); DE (1); JP (3); ME (1); CH (1); TU (2); BU (1); AR (3); PL (2); HU (3); RO (3); KR (1); DK (1)