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

Ulcerative Colitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05672199
• Other study ID #: 20210210
• Secondary ID: 2022-001686-12
• Status: Recruiting
• Phase: Phase 2
• Start date: April 28, 2023
• Est. completion date: January 27, 2028

Study information

• Verified date: June 2024
• Source: Amgen
• Contact: Amgen Call Center
• Phone: 866-572-6436
• Email: medinfo[@]amgen.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: January 27, 2028
• Est. primary completion date: January 27, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

Drug:
• Efavaleukin alfa
Subcutaneous (SC) injection
• Placebo
SC injection

Locations

Country	Name	City	State
Argentina	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
Bulgaria	Diagnostic-Consultative Center Convex EOOD	Sofia
Denmark	Herlev Hospital	Herlev
Germany	Universitaetsklinikum Ulm	Ulm
Hungary	Clinexpert Kft	Budapest
Hungary	MIND Klinika Kft	Budapest
Hungary	Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont Altalanos Orvostudomanyi Kar	Szeged
Japan	Tsujinaka Hospital Kashiwanoha	Kashiwa-shi	Chiba
Japan	Nagasaki University Hospital	Nagasaki-shi	Nagasaki
Korea, Republic of	Wonju Severance Christian Hospital	Wonju-si, Gangwon-do
Mexico	Clinica de Investigacion en Reumatologia y Obesidad SC	Guadalajra	Jalisco
Poland	NZOZ Twoje Zdrowie EL Spzoo	Elblag
Poland	Centrum Medyczne Melita Medical	Wroclaw-Krzyki
Romania	Clinica Medicum	Bucuresti
Romania	Spitalul Clinic Colentina	Bucuresti
Romania	Spitalul de Oncologie Monza SRL	Bucuresti
Switzerland	Intesto BE	Bern
Turkey	Kocaeli Universitesi Tip Fakultesi Hastanesi	Kocaeli
Turkey	Mersin Universitesi Tip Fakultesi Hastanesi	Mersin
United States	University of Kansas Medical Center	Kansas City	Kansas
United States	Indian Health Service Health Research	Kissimmee	Florida
United States	Santa Maria Gastroenterology Medical Group	Santa Maria	California

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Countries where clinical trial is conducted

United States,  Argentina,  Bulgaria,  Denmark,  Germany,  Hungary,  Japan,  Korea, Republic of,  Mexico,  Poland,  Romania,  Switzerland,  Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with Treatment-emergent Adverse Events (TEAEs)		Day 1 to Week 110
Secondary	Number of Participants with Clinical Response at Week 52		Week 52
Secondary	Number of Participants with Clinical Response at Week 104		Week 104
Secondary	Number of Participants with Clinical Remission at Week 52		Week 52
Secondary	Number of Participants with Clinical Remission at Week 104		Week 104
Secondary	Number of Participants with Durable Clinical Remission at Week 52		Week 52
Secondary	Number of Participants with Durable Clinical Remission at Week 104		Week 104
Secondary	Number of Participants with Endoscopic Remission at Week 52		Week 52
Secondary	Number of Participants with Endoscopic Remission at Week 104		Week 104
Secondary	Number of Participants with Histologic Remission at Week 52		Week 52
Secondary	Number of Participants with Histologic Remission at Week 104		Week 104
Secondary	Number of Participants with Corticosteroid-free Remission	Measured in participants receiving corticosteroids at randomization of parent Study 20170104.	Week 52
Secondary	Number of Participants with Corticosteroid-free Remission	Measured in participants receiving corticosteroids at randomization of parent Study 20170104.	Week 104
Secondary	Number of Participants with Combined Endoscopic and Histologic Remission at Week 52		Week 52
Secondary	Number of Participants with Combined Endoscopic and Histologic Remission at Week 104		Week 104
Secondary	Number of Participants with Symptomatic Remission at Week 52		Week 52
Secondary	Number of Participants with Symptomatic Remission at Week 104		Week 104
Secondary	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)
Secondary	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)

External Links

•   AmgenTrials clinical trials website