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

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

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).

Study Overview

• Status: Recruiting
• Conditions: Ulcerative Colitis
• Intervention / Treatment: Drug: Placebo; Drug: Efavaleukin alfa

• Study Type: Interventional
• Enrollment (Estimated): 140
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Amgen Call Center; Phone Number: 866-572-6436; Email: medinfo@amgen.com

Study Locations

• Argentina
  • Buenos Aires
    • Mar del Plata, Buenos Aires, Argentina, B7600DHK
      • Recruiting
      • Centro de Investigaciones Medicas Mar del Plata
    • Quilmes, Buenos Aires, Argentina, B1878DVB
      • Recruiting
      • Cer Instituto Medico
• Bulgaria
  • Sofia, Bulgaria, 1680
    • Recruiting
    • Diagnostic-Consultative Center Convex EOOD
• Denmark
  • Herlev, Denmark, 2730
    • Recruiting
    • Herlev Hospital
• Germany
  • Ulm, Germany, 89081
    • Recruiting
    • Universitaetsklinikum Ulm
• Hungary
  • Budapest, Hungary, 1024
    • Recruiting
    • MIND Klinika Kft
  • Budapest, Hungary, 1033
    • Recruiting
    • Clinexpert Kft
  • Szeged, Hungary, 6725
    • Recruiting
    • Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont Altalanos Orvostudomanyi Kar
• Japan
  • Chiba
    • Kashiwa-shi, Chiba, Japan, 277-0871
      • Recruiting
      • Tsujinaka Hospital Kashiwanoha
  • Nagasaki
    • Nagasaki-shi, Nagasaki, Japan, 852-8501
      • Recruiting
      • Nagasaki University Hospital
• Korea, Republic of
  • Wonju-si, Gangwon-do, Korea, Republic of, 26426
    • Recruiting
    • Wonju Severance Christian Hospital
• Mexico
  • Jalisco
    • Guadalajra, Jalisco, Mexico, 44650
      • Recruiting
      • Clinica de Investigacion en Reumatologia y Obesidad SC
• Poland
  • Elblag, Poland, 82-300
    • Recruiting
    • NZOZ Twoje Zdrowie EL Spzoo
  • Wroclaw-Krzyki, Poland, 50-449
    • Recruiting
    • Centrum Medyczne Melita Medical
• Romania
  • Bucuresti, Romania, 020125
    • Recruiting
    • Spitalul Clinic Colentina
  • Bucuresti, Romania, 012015
    • Recruiting
    • Clinica Medicum
  • Bucuresti, Romania, 013812
    • Recruiting
    • Spitalul de Oncologie Monza Srl
• Switzerland
  • Bern, Switzerland, 3012
    • Recruiting
    • Intesto BE
• Turkey
  • Kocaeli, Turkey, 41001
    • Recruiting
    • Kocaeli Universitesi Tip Fakultesi Hastanesi
  • Mersin, Turkey, 33343
    • Recruiting
    • Mersin Universitesi Tip Fakultesi Hastanesi
• United States
  • California
    • Santa Maria, California, United States, 93458
      • Recruiting
      • Santa Maria Gastroenterology Medical Group
  • Florida
    • Kissimmee, Florida, United States, 34741
      • Recruiting
      • Indian Health Service Health Research
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • Recruiting
      • University of Kansas Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion criteria:

• 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:

• 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:
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 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.	Drug: Placebo; SC injection
Experimental: 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.	Drug: Efavaleukin alfa; Subcutaneous (SC) injection; Other Names: AMG 592
Experimental: 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.	Drug: Efavaleukin alfa; Subcutaneous (SC) injection; Other Names: AMG 592
Experimental: 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.	Drug: Efavaleukin alfa; Subcutaneous (SC) injection; Other Names: AMG 592

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of Participants with Treatment-emergent Adverse Events (TEAEs)	Day 1 to Week 110

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Number of Participants with Durable Clinical Remission at Week 104		Week 104
Number of Participants with Endoscopic Remission at Week 52		Week 52
Number of Participants with Endoscopic Remission at Week 104		Week 104
Number of Participants with Histologic Remission at Week 52		Week 52
Number of Participants with Histologic Remission at Week 104		Week 104
Number of Participants with Combined Endoscopic and Histologic Remission at Week 52		Week 52
Number of Participants with Combined Endoscopic and Histologic Remission at Week 104		Week 104
Number of Participants with Symptomatic Remission at Week 52		Week 52
Number of Participants with Symptomatic Remission at Week 104		Week 104
Change from Baseline of Study 20170104 in Histological Score (Geboes) at Week 52		Baseline of Study 20170104 to Week 52 of Long Term Extension Study (up to approximately 104 weeks)
Change from Baseline of Study 20170104 in Histological Score (Geboes) at Week 104		Baseline of Study 20170104 to Week 104 of Long Term Extension Study (up to approximately 156 weeks)
Number of Participants with Corticosteroid-free Remission	Measured in participants receiving corticosteroids at randomization of parent Study 20170104.	Week 52
Number of Participants with Corticosteroid-free Remission	Measured in participants receiving corticosteroids at randomization of parent Study 20170104.	Week 104

Collaborators and Investigators

• Sponsor: Amgen
• Investigators: Study Director: MD, Amgen

Publications and helpful links

Helpful Links

• AmgenTrials clinical trials website

Study record dates

Study Major Dates

• Study Start (Actual): April 28, 2023
• Primary Completion (Estimated): May 31, 2028
• Study Completion (Estimated): May 31, 2028

Study Registration Dates

• First Submitted: January 3, 2023
• First Submitted That Met QC Criteria: January 3, 2023
• First Posted (Actual): January 5, 2023

Study Record Updates

• Last Update Posted (Actual): March 15, 2024
• Last Update Submitted That Met QC Criteria: March 13, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Ulcerative colitis; UC; Moderately to severely active ulcerative colitis; Efavaleukin alfa; AMG 592
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Intestinal Diseases; Inflammatory Bowel Diseases; Ulcer; Colitis; Colitis, Ulcerative
• Other Study ID Numbers: 20210210; 2022-001686-12 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
• IPD Sharing 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.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No