Clinical trial NCT05672199: Long-term Safety and Efficacy of Efavaleukin Alfa in Participants With Moderately to Severely Active Ulcerative Colitis
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Ulcerative Colitis
Keywords: Ulcerative colitis
UC
Moderately to severely active ulcerative colitis
Efavaleukin alfa
AMG 592
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2023-01-05
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants with Treatment-emergent Adverse Events (TEAEs)
timeFrame: Day 1 to Week 110
Secondary outcomes:
measure: Number of Participants with Clinical Response at Week 52
timeFrame: Week 52
measure: Number of Participants with Clinical Response at Week 104
timeFrame: Week 104
measure: Number of Participants with Clinical Remission at Week 52
timeFrame: Week 52
measure: Number of Participants with Clinical Remission at Week 104
timeFrame: Week 104
measure: Number of Participants with Durable Clinical Remission at Week 52
timeFrame: Week 52
measure: Number of Participants with Durable Clinical Remission at Week 104
timeFrame: Week 104
measure: Number of Participants with Endoscopic Remission at Week 52
timeFrame: Week 52
measure: Number of Participants with Endoscopic Remission at Week 104
timeFrame: Week 104
measure: Number of Participants with Histologic Remission at Week 52
timeFrame: Week 52
measure: Number of Participants with Histologic Remission at Week 104
timeFrame: Week 104
measure: Number of Participants with Corticosteroid-free Remission
timeFrame: Week 52
measure: Number of Participants with Corticosteroid-free Remission
timeFrame: Week 104
measure: Number of Participants with Combined Endoscopic and Histologic Remission at Week 52
timeFrame: Week 52
measure: Number of Participants with Combined Endoscopic and Histologic Remission at Week 104
timeFrame: Week 104
measure: Number of Participants with Symptomatic Remission at Week 52
timeFrame: Week 52
measure: Number of Participants with Symptomatic Remission at Week 104
timeFrame: Week 104
measure: Change from Baseline of Study 20170104 in Histological Score (Geboes) at Week 52
timeFrame: Baseline of Study 20170104 to Week 52 of Long Term Extension Study (up to approximately 104 weeks)
measure: Change from Baseline of Study 20170104 in Histological Score (Geboes) at Week 104
timeFrame: Baseline of Study 20170104 to Week 104 of Long Term Extension Study (up to approximately 156 weeks)
Other outcomes:
Locations:
city: Santa Maria
country: United States
facility: Santa Maria Gastroenterology Medical Group
state: California
city: Kissimmee
country: United States
facility: Indian Health Service Health Research
state: Florida
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Mar del Plata
country: Argentina
facility: Centro de Investigaciones Medicas Mar del Plata
state: Buenos Aires
city: Munro
country: Argentina
facility: Clinica Independencia
state: Buenos Aires
city: Quilmes
country: Argentina
facility: Cer Instituto Medico
state: Buenos Aires
city: Sofia
country: Bulgaria
facility: Diagnostic-Consultative Center Convex EOOD
city: Herlev
country: Denmark
facility: Herlev Hospital
city: Ulm
country: Germany
facility: Universitaetsklinikum Ulm
city: Budapest
country: Hungary
facility: MIND Klinika Kft
city: Budapest
country: Hungary
facility: Clinexpert Kft
city: Szeged
country: Hungary
facility: Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont Altalanos Orvostudomanyi Kar
city: Kashiwa-shi
country: Japan
facility: Tsujinaka Hospital Kashiwanoha
state: Chiba
city: Nagasaki-shi
country: Japan
facility: Nagasaki University Hospital
state: Nagasaki
city: Ome-shi
country: Japan
facility: Ome Medical Center
state: Tokyo
city: Wonju-si, Gangwon-do
country: Korea, Republic of
facility: Wonju Severance Christian Hospital
city: Guadalajra
country: Mexico
facility: Clinica de Investigacion en Reumatologia y Obesidad SC
state: Jalisco
city: Elblag
country: Poland
facility: NZOZ Twoje Zdrowie EL Spzoo
city: Wroclaw-Krzyki
country: Poland
facility: Centrum Medyczne Melita Medical
city: Bucuresti
country: Romania
facility: Clinica Medicum
city: Bucuresti
country: Romania
facility: Memorial Healthcare International SRL
city: Bucuresti
country: Romania
facility: Spitalul Clinic Colentina
city: Bern
country: Switzerland
facility: Intesto BE
city: Kocaeli
country: Turkey
facility: Kocaeli Universitesi Tip Fakultesi Hastanesi
city: Mersin
country: Turkey
facility: Mersin Universitesi Tip Fakultesi Hastanesi
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References: