RecruitingPhase 1interventionalRules rewrite

Phase 1: testing Aletekitug for Colitis, Ulcerative

This goal of this sub-study is to learn how safe and tolerable the study drug, aletekitug (anti-IL-18), in participants with moderately to severely active ulcerative colitis (UC). This study is the sub-study of the platform trial.

Official registry: https://clinicaltrials.gov/study/NCT07747480 · GlaxoSmithKline · enrollment listed as 16

What this phase means

Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Aletekitug. The registry lists allocation as na. This goal of this sub-study is to learn how safe and tolerable the study drug, aletekitug (anti-IL-18), in participants with moderately to severely active ulcerative colitis (UC).

They plan to enroll about 16 people at Oxford. Taking part typically means an infusion or injection of a biologic plus check-ins.

Official title (unrewritten)

A Phase 1b, Non-Randomized, Open-Label, Repeat-Dose, Single Center Study to Investigate the Safety and Tolerability of Aletekitug in Advanced Therapy Naïve Participants With Moderate to Severe Ulcerative Colitis

Interventions: Aletekitug

Primary outcome (registry wording): Number of Participants with Adverse events (AEs)

Who it is for (from inclusion criteria)

Ages 18 Years to 75 Years
Diagnosis of UC for greater than or equal (\>=) 3 months before screening. Appropriate documentation of endoscopy and biopsy results consistent with the diagnosis of UC must be available
Active UC with a modified Mayo score (mMS) of 5 to 9 points and endoscopy sub score of 2 to 3 within 14 days before baseline biopsy collection
Active disease beyond the rectum (greater than \[\>\]15 centimeter \[cm\] of active disease from the anal verge at the screening colonoscopy)
Demonstrated an inadequate response to, loss of response to, or intolerance to conventional therapy (e.g., oral 5- aminosalicyclic acid \[5-ASA\] compounds, corticosteroids, thiopurines)
May have been receiving a conventional therapy if the prescribed dose has been stable for the required time period before the screening endoscopy
Must meet contraception requirements if a female participant is a woman of childbearing potential (WOCBP)

Who the registry excludes

Have prior history of dysplasia of the gastrointestinal tract or found to have dysplasia, other than completely removed low-grade dysplastic lesions, in any biopsy performed during the screening endoscopy
Have a history of malignant neoplasm within the last 5 years
Have history of lymphoproliferative disorder, including lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease
Have any active, chronic, or recurrent infections based on the investigator's assessment
Have history of opportunistic infections within 1 year of screening
Have evidence of active or latent Tuberculosis (TB) as documented by medical history, examination, and TB testing at Screening:
Have significant allergies to humanized monoclonal antibodies

Public study contact (from the registry)

US GSK Clinical Trials Call Center

877-379-3718

GSKClinicalSupportHD@gsk.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

1 listed

GSK Investigational Site — Oxford, United Kingdom (recruiting)

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FAQ about this NCT record

Is NCT07747480 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07747480?

Phase 1. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07747480?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary