RecruitingPhase 1interventionalRules rewrite

Phase 1: testing Aletekitug (GSK1070806) for Colitis, Ulcerative

This study will look at how safe and tolerable different treatments are for adults who have moderate to severe ulcerative colitis (UC). The platform design uses one single master protocol that explains how the overall study is organized, whereas each treatment, as sub-study will be tested to see how well the study drug works and how it affects participants.

Official registry: https://clinicaltrials.gov/study/NCT07747467 · GlaxoSmithKline · enrollment listed as 8

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 (GSK1070806). The registry lists allocation as na. This study will look at how safe and tolerable different treatments are for adults who have moderate to severe ulcerative colitis (UC).

They plan to enroll about 8 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 Utilizing a Master Protocol to Investigate the Safety and Tolerability of Multiple Study Interventions in Advanced Therapy Naïve Participants With Moderate to Severe Ulcerative Colitis

Interventions: Aletekitug (GSK1070806)

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, in the assessment of the investigator, 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

Who the registry excludes

Participants with current diagnosis of Crohn's disease (CD) or Inflammatory bowel disease-unclassified (IBD-U) or a history of radiation colitis, microscopic colitis or ischemic colitis
Have currently known complications of UC such as fulminant colitis, or toxic megacolon, stoma, or stricture/stenosis within the small bowel or colon
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 (

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 NCT07747467 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 NCT07747467?

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 NCT07747467?

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