Ulcerative ColitisPhase 2NCT05672199
Long-term Safety and Efficacy of Efavaleukin Alfa in Participants With Moderately to Severely Active Ulcerative Colitis
A Phase 2 study testing Efavaleukin alfa in people with Ulcerative Colitis, run by Amgen at 25 sites in 13 countries.
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). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- Efavaleukin alfa
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 25 sitesin 13 countries
- Study dates
- 28 Apr 2023to 31 Oct 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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:
Show all 24Show fewer
- 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.
Trial locations and contacts
25 sites in 13 countries.
25 sites in 13 countries
United States3 sites
University of Kansas Medical Center
Kansas City, Kansas, 66160
Indian Health Service Health Research
Kissimmee, Florida, 34741
Santa Maria Gastroenterology Medical Group
Santa Maria, California, 93458
Argentina3 sites
Centro de Investigaciones Medicas Mar del Plata
Mar del Plata, Buenos Aires, B7600DHK
Clinica Independencia
Munro, Buenos Aires, 1605
Cer Instituto Medico
Quilmes, Buenos Aires, B1878DVB
Hungary3 sites
MIND Klinika Kft
Budapest, 1024
Clinexpert Kft
Budapest, 1033
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont Altalanos Orvostudomanyi Kar
Szeged, 6725
Japan3 sites
Tsujinaka Hospital Kashiwanoha
Kashiwa-shi, Chiba, 277-0871
Nagasaki University Hospital
Nagasaki, Nagasaki, 852-8501
Ome Medical Center
Ome-shi, Tokyo, 198-0042
Romania3 sites
Clinica Medicum
Bucharest, 012015
Memorial Healthcare International SRL
Bucharest, 013812
Spitalul Clinic Colentina
Bucharest, 020125
Poland2 sites
NZOZ Twoje Zdrowie EL Spzoo
Elblag, 82-300
Centrum Medyczne Melita Medical
Wroclaw-Krzyki, 50-449
Turkey (Türkiye)2 sites
Kocaeli Universitesi Tip Fakultesi Hastanesi
Kocaeli, 41001
Mersin Universitesi Tip Fakultesi Hastanesi
Mersin, 33343
Mexico1 site
Clinica de Investigacion en Reumatologia y Obesidad SC
Guadalajra, Jalisco, 44650
South Korea1 site
Wonju Severance Christian Hospital
Wonju-si, Gangwon-do, 26426
About this study
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
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
- Being tested
- Efavaleukin alfa, Placebo
- Keywords
- Ulcerative colitis, UC, Moderately to severely active ulcerative colitis, Efavaleukin alfa, AMG 592
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Efavaleukin alfaDrug
Also called AMG 592
Subcutaneous (SC) injection
PlaceboDrug
SC injection
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Drug: Efavaleukin alfa |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Measured: Day 1 to Week 110
Secondary outcomes (18)
Number of Participants with Clinical Response at Week 52
Measured: Week 52
Number of Participants with Clinical Response at Week 104
Measured: Week 104
Number of Participants with Clinical Remission at Week 52
Measured: Week 52
Number of Participants with Clinical Remission at Week 104
Measured: Week 104
Number of Participants with Durable Clinical Remission at Week 52
Measured: Week 52
Number of Participants with Durable Clinical Remission at Week 104
Measured: Week 104
Number of Participants with Endoscopic Remission at Week 52
Measured: Week 52
Number of Participants with Endoscopic Remission at Week 104
Measured: Week 104
Number of Participants with Histologic Remission at Week 52
Measured: Week 52
Number of Participants with Histologic Remission at Week 104
Measured: Week 104
Number of Participants with Corticosteroid-free Remission
Measured in participants receiving corticosteroids at randomization of parent Study 20170104.
Measured: Week 52
Number of Participants with Corticosteroid-free Remission
Measured in participants receiving corticosteroids at randomization of parent Study 20170104.
Measured: Week 104
Number of Participants with Combined Endoscopic and Histologic Remission at Week 52
Measured: Week 52
Number of Participants with Combined Endoscopic and Histologic Remission at Week 104
Measured: Week 104
Number of Participants with Symptomatic Remission at Week 52
Measured: Week 52
Number of Participants with Symptomatic Remission at Week 104
Measured: Week 104
Change from Baseline of Study 20170104 in Histological Score (Geboes) at Week 52
Measured: 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
Measured: Baseline of Study 20170104 to Week 104 of Long Term Extension Study (up to approximately 156 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2023
- Study start28 Apr 2023
- Primary completion31 Oct 2024
- Study completion31 Oct 2024
Why it stopped: The parent study 20170104 was terminated due to the study meeting a prespecified futility rule. Consequently, this study was terminated.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- More trials run by AmgenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05672199
- Sponsor's protocol ID
- 20210210
- Other IDs
- 2022-001686-12
- Status last verified
- Oct 2025
- First submitted
- 3 Jan 2023
- Last updated
- 15 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05672199
- Acronym / sponsor ID
- 20210210
- Conditions
- Ulcerative Colitis
- Keywords
- Ulcerative colitis, UC, Moderately to severely active ulcerative colitis, Efavaleukin alfa, AMG 592
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The parent study 20170104 was terminated due to the study meeting a prespecified futility rule. Consequently, this study was terminated.
- Enrolment
- 25 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 28 Apr 2023 (actual)
- Primary completion
- 31 Oct 2024 (actual)
- Study completion
- 31 Oct 2024 (actual)
- First posted
- 5 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboParticipants 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. |
| Efavaleukin Alfa Dose 1 (Low Dose) | Experimental | Drug: Efavaleukin alfaParticipants 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. |
| Efavaleukin Alfa Dose 2 (Moderate Dose) | Experimental | Drug: Efavaleukin alfaParticipants 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. |
| Efavaleukin Alfa Dose 3 (High Dose) | Experimental | Drug: Efavaleukin alfaParticipants 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (24 listed)
- 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.
- Adenoma and dysplasia exclusion criteria:
- Any history or current evidence of high-grade dysplasia.
- Any history or current evidence of dysplasia occurring in flat mucosa.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Efavaleukin alfaAlso: AMG 592Subcutaneous (SC) injection | Drug | Efavaleukin Alfa Dose 1 (Low Dose), Efavaleukin Alfa Dose 2 (Moderate Dose), Efavaleukin Alfa Dose 3 (High Dose) |
| PlaceboSC injection | Drug | Placebo |
Primary outcome
Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Time frame: Day 1 to Week 110
18 secondary outcomes
Number of Participants with Clinical Response at Week 52
Time frame: Week 52
Number of Participants with Clinical Response at Week 104
Time frame: Week 104
Number of Participants with Clinical Remission at Week 52
Time frame: Week 52
Number of Participants with Clinical Remission at Week 104
Time frame: Week 104
Number of Participants with Durable Clinical Remission at Week 52
Time frame: Week 52
Number of Participants with Durable Clinical Remission at Week 104
Time frame: Week 104
Number of Participants with Endoscopic Remission at Week 52
Time frame: Week 52
Number of Participants with Endoscopic Remission at Week 104
Time frame: Week 104
Number of Participants with Histologic Remission at Week 52
Time frame: Week 52
Number of Participants with Histologic Remission at Week 104
Time frame: Week 104
Number of Participants with Corticosteroid-free Remission
Time frame: Week 52
Number of Participants with Corticosteroid-free Remission
Time frame: Week 104
Number of Participants with Combined Endoscopic and Histologic Remission at Week 52
Time frame: Week 52
Number of Participants with Combined Endoscopic and Histologic Remission at Week 104
Time frame: Week 104
Number of Participants with Symptomatic Remission at Week 52
Time frame: Week 52
Number of Participants with Symptomatic Remission at Week 104
Time frame: Week 104
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)
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)
Results and safety
The study was stopped early (reason given: The parent study 20170104 was terminated due to the study meeting a prespecified futility rule. Consequently, this study was terminated.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2025.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MD study director
Amgen
25 sites in 13 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Efavaleukin alfa in people with Ulcerative Colitis, run by Amgen at 25 sites in 13 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in United States, Argentina, Hungary, Japan, Romania and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: The parent study 20170104 was terminated due to the study meeting a prespecified futility rule. Consequently, this study was terminated.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Treatment-emergent Adverse Events (TEAEs) (time frame: Day 1 to Week 110). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2025.