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New drug shows promise for Long-Term ulcerative colitis control

NCT ID NCT05672199

Disease control Sponsor: Amgen Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested a drug called efavaleukin alfa in people with moderate to severe ulcerative colitis who had already completed a previous study. The goal was to see if the drug is safe and works over a longer period, up to 104 weeks. The study was terminated early and enrolled only 25 participants.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
efavaleukin alfa (AMG 592)
What this could lead to
If it works, this could provide a new long-term treatment option for people with moderate to severe ulcerative colitis.
What could go wrong
This is a small, early-phase extension study that was terminated, so results may be limited. The drug may not prove effective or safe over the long term.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

25 people

The number who actually took part.

Started

Apr 2023

Finished

Oct 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

ulcerative colitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Ulcerative colitis

Contacts and locations

Locations

  • Centro de Investigaciones Medicas Mar del Plata

    Mar del Plata, Buenos Aires, B7600DHK, Argentina

  • Centrum Medyczne Melita Medical

    Wroclaw-Krzyki, 50-449, Poland

  • Cer Instituto Medico

    Quilmes, Buenos Aires, B1878DVB, Argentina

  • Clinexpert Kft

    Budapest, 1033, Hungary

  • Clinica Independencia

    Munro, Buenos Aires, 1605, Argentina

  • Clinica Medicum

    Bucharest, 012015, Romania

  • Clinica de Investigacion en Reumatologia y Obesidad SC

    Guadalajra, Jalisco, 44650, Mexico

  • Diagnostic-Consultative Center Convex EOOD

    Sofia, 1680, Bulgaria

  • Herlev Hospital

    Herlev, 2730, Denmark

  • Indian Health Service Health Research

    Kissimmee, Florida, 34741, United States

  • Intesto BE

    Bern, 3012, Switzerland

  • Kocaeli Universitesi Tip Fakultesi Hastanesi

    Kocaeli, 41001, Turkey (Türkiye)

  • MIND Klinika Kft

    Budapest, 1024, Hungary

  • Memorial Healthcare International SRL

    Bucharest, 013812, Romania

  • Mersin Universitesi Tip Fakultesi Hastanesi

    Mersin, 33343, Turkey (Türkiye)

  • NZOZ Twoje Zdrowie EL Spzoo

    Elblag, 82-300, Poland

  • Nagasaki University Hospital

    Nagasaki, Nagasaki, 852-8501, Japan

  • Ome Medical Center

    Ome-shi, Tokyo, 198-0042, Japan

  • Santa Maria Gastroenterology Medical Group

    Santa Maria, California, 93458, United States

  • Spitalul Clinic Colentina

    Bucharest, 020125, Romania

  • Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont Altalanos Orvostudomanyi Kar

    Szeged, 6725, Hungary

  • Tsujinaka Hospital Kashiwanoha

    Kashiwa-shi, Chiba, 277-0871, Japan

  • Universitaetsklinikum Ulm

    Ulm, 89081, Germany

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160, United States

  • Wonju Severance Christian Hospital

    Wonju-si, Gangwon-do, 26426, South Korea

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