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

Primary Purpose

Ulcerative Colitis

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Efavaleukin alfa
Placebo
Sponsored by
Amgen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ulcerative Colitis focused on measuring Ulcerative colitis, UC, Moderately to severely active ulcerative colitis, Efavaleukin alfa, AMG 592

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Santa Maria Gastroenterology Medical GroupRecruiting
  • University of Kansas Medical CenterRecruiting
  • Centro de Investigaciones Medicas Mar del PlataRecruiting
  • Cer Instituto MedicoRecruiting
  • Tsujinaka Hospital KashiwanohaRecruiting
  • Nagasaki University HospitalRecruiting
  • Wonju Severance Christian HospitalRecruiting
  • Spitalul Clinic ColentinaRecruiting
  • Intesto BERecruiting
  • Kocaeli Universitesi Tip FakultesiRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Arm Label

Placebo

Efavaleukin Alfa Dose 1 (Low Dose)

Efavaleukin Alfa Dose 2 (Moderate Dose)

Efavaleukin Alfa Dose 3 (High Dose)

Arm Description

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Number of Participants with Clinical Response at Week 52
Number of Participants with Clinical Response at Week 104
Number of Participants with Clinical Remission at Week 52
Number of Participants with Clinical Remission at Week 104
Number of Participants with Durable Clinical Remission at Week 52
Number of Participants with Durable Clinical Remission at Week 104
Number of Participants with Endoscopic Remission at Week 52
Number of Participants with Endoscopic Remission at Week 104
Number of Participants with Histologic Remission at Week 52
Number of Participants with Histologic Remission at Week 104
Number of Participants with Corticosteroid-free Remission
Measured in participants receiving corticosteroids at randomization of parent Study 20170104.
Number of Participants with Corticosteroid-free Remission
Measured in participants receiving corticosteroids at randomization of parent Study 20170104.
Number of Participants with Combined Endoscopic and Histologic Remission at Week 52
Number of Participants with Combined Endoscopic and Histologic Remission at Week 104
Number of Participants with Symptomatic Remission at Week 52
Number of Participants with Symptomatic Remission at Week 104
Change from Baseline of Study 20170104 in Histological Score (Geboes) at Week 52
Change from Baseline of Study 20170104 in Histological Score (Geboes) at Week 104

Full Information

First Posted
January 3, 2023
Last Updated
October 18, 2023
Sponsor
Amgen
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1. Study Identification

Unique Protocol Identification Number
NCT05672199
Brief Title
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

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 28, 2023 (Actual)
Primary Completion Date
April 26, 2027 (Anticipated)
Study Completion Date
April 26, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Amgen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis
Keywords
Ulcerative colitis, UC, Moderately to severely active ulcerative colitis, Efavaleukin alfa, AMG 592

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Efavaleukin Alfa Dose 1 (Low Dose)
Arm Type
Experimental
Arm Description
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.
Arm Title
Efavaleukin Alfa Dose 2 (Moderate Dose)
Arm Type
Experimental
Arm Description
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.
Arm Title
Efavaleukin Alfa Dose 3 (High Dose)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Efavaleukin alfa
Other Intervention Name(s)
AMG 592
Intervention Description
Subcutaneous (SC) injection
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
SC injection
Primary Outcome Measure Information:
Title
Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Time Frame
Day 1 to Week 110
Secondary Outcome Measure Information:
Title
Number of Participants with Clinical Response at Week 52
Time Frame
Week 52
Title
Number of Participants with Clinical Response at Week 104
Time Frame
Week 104
Title
Number of Participants with Clinical Remission at Week 52
Time Frame
Week 52
Title
Number of Participants with Clinical Remission at Week 104
Time Frame
Week 104
Title
Number of Participants with Durable Clinical Remission at Week 52
Time Frame
Week 52
Title
Number of Participants with Durable Clinical Remission at Week 104
Time Frame
Week 104
Title
Number of Participants with Endoscopic Remission at Week 52
Time Frame
Week 52
Title
Number of Participants with Endoscopic Remission at Week 104
Time Frame
Week 104
Title
Number of Participants with Histologic Remission at Week 52
Time Frame
Week 52
Title
Number of Participants with Histologic Remission at Week 104
Time Frame
Week 104
Title
Number of Participants with Corticosteroid-free Remission
Description
Measured in participants receiving corticosteroids at randomization of parent Study 20170104.
Time Frame
Week 52
Title
Number of Participants with Corticosteroid-free Remission
Description
Measured in participants receiving corticosteroids at randomization of parent Study 20170104.
Time Frame
Week 104
Title
Number of Participants with Combined Endoscopic and Histologic Remission at Week 52
Time Frame
Week 52
Title
Number of Participants with Combined Endoscopic and Histologic Remission at Week 104
Time Frame
Week 104
Title
Number of Participants with Symptomatic Remission at Week 52
Time Frame
Week 52
Title
Number of Participants with Symptomatic Remission at Week 104
Time Frame
Week 104
Title
Change from Baseline of Study 20170104 in Histological Score (Geboes) at Week 52
Time Frame
Baseline of Study 20170104 to Week 52 of Long Term Extension Study (up to approximately 104 weeks)
Title
Change from Baseline of Study 20170104 in Histological Score (Geboes) at Week 104
Time Frame
Baseline of Study 20170104 to Week 104 of Long Term Extension Study (up to approximately 156 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amgen Call Center
Phone
866-572-6436
Email
medinfo@amgen.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MD
Organizational Affiliation
Amgen
Official's Role
Study Director
Facility Information:
Facility Name
Santa Maria Gastroenterology Medical Group
City
Santa Maria
State/Province
California
ZIP/Postal Code
93458
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Individual Site Status
Recruiting
Facility Name
Centro de Investigaciones Medicas Mar del Plata
City
Mar del Plata
State/Province
Buenos Aires
ZIP/Postal Code
B7600DHK
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Cer Instituto Medico
City
Quilmes
State/Province
Buenos Aires
ZIP/Postal Code
B1878DVB
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Tsujinaka Hospital Kashiwanoha
City
Kashiwa-shi
State/Province
Chiba
ZIP/Postal Code
277-0871
Country
Japan
Individual Site Status
Recruiting
Facility Name
Nagasaki University Hospital
City
Nagasaki-shi
State/Province
Nagasaki
ZIP/Postal Code
852-8501
Country
Japan
Individual Site Status
Recruiting
Facility Name
Wonju Severance Christian Hospital
City
Wonju-si, Gangwon-do
ZIP/Postal Code
26426
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Spitalul Clinic Colentina
City
Bucuresti
ZIP/Postal Code
020125
Country
Romania
Individual Site Status
Recruiting
Facility Name
Intesto BE
City
Bern
ZIP/Postal Code
3012
Country
Switzerland
Individual Site Status
Recruiting
Facility Name
Kocaeli Universitesi Tip Fakultesi
City
Kocaeli
ZIP/Postal Code
41001
Country
Turkey
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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 URL
http://www.amgen.com/datasharing
Links:
URL
http://www.amgentrials.com
Description
AmgenTrials clinical trials website

Learn more about this trial

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

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