Treatment study to test multiple interventions for moderate to severe ulcerative colitis
Official title: 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
Run by GlaxoSmithKline · NCT07747467 · Data updated 2026-11-12
This study tests whether a single master protocol can safely test the anti-IL-18 treatment Aletekitug (GSK1070806) in adults with moderate to severe ulcerative colitis to see if it is tolerable and potentially beneficial.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 8 (estimated) |
| Sponsor | GlaxoSmithKline Industry-sponsored |
| Drugs / interventions | rituximab, radiation |
| Locations | 1 site (Oxford) |
| Status | Recruiting |
| Started | September 3, 2026 |
| Main results expected | March 21, 2029 |
| Study ends | March 21, 2029 |
| Registry record updated | October 28, 2026 |
| Trial ID | NCT07747467 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with active moderate to severe ulcerative colitis (mMS 5-9, endoscopy subscore 2-3) who have had inadequate response or intolerance to conventional therapy.
✕Probably not a fit
Patients with disease outside the eligibility window or who do not respond to the study drug in the sub-studies may not experience benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This early-phase study uses a master protocol to evaluate multiple sub-studies under one framework. The focus is on safety and tolerability of Aletekitug (GSK1070806) in adults with active ulcerative colitis. Eligible participants have a documented UC diagnosis for at least three months and active disease despite conventional therapy. The trial will measure safety signals, tolerability, and preliminary signals of efficacy across sub-studies, with centralized monitoring under a single protocol structure. Lead sponsor is GlaxoSmithKline, conducting at least one investigational site in Oxford, UK.
Why it matters
Potential benefit: If successful, participants may experience relief from symptoms and gain insight into a new therapeutic option for ulcerative colitis.
How similar studies have gone: Prior studies in this area have shown safety signals for anti-IL-18 strategies in inflammatory bowel disease, though this exact master-protocol approach is relatively novel for UC.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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). * Documentation of a surveillance colonoscopy (performed according to local standard) within 12 months before screening (may be performed during screening) for participants with pancolitis of \>8 years duration or left-sided colitis of \>12 years duration, or primary sclerosing cholangitis * 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 Exclusion Criteria: * 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 ( * Have history or presence of significant medical illness including but not limited to cardiovascular, respiratory, gastrointestinal (excluding UC), hepatic, renal, endocrine, hematologic, neurological, and psychiatric disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention or interfering with the interpretation of the data. * 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. * Have clinically significant multiple or severe drug allergies, intolerance to topical corticosteroids, or severe post-treatment hypersensitivity reactions . * Have had previous colectomy (total or subtotal), or any other manifestation that might require surgery while enrolled in the trial. * Have ostomy or ileoanal pouch. * Have received any of the following for treatments of UC: * Immunomodulatory medications, including cyclosporine, tacrolimus, mycophenolate mofetil, thalidomide, within 4 weeks before screening endoscopy. * Topical (rectal) treatment of 5-ASA or corticosteroid enemas/suppositories within 2 weeks of screening endoscopy. * Have received approved or investigational advanced therapy (ATs) (i.e., biologics or small molecules including biosimilars). * Interferon therapy within 8 weeks before screening endoscopy. * Agents that deplete B- or T-cells (e.g., rituximab) within 12 months of baseline. Participants remain excluded if there is evidence of persistent targeted lymphocyte depletion at the time of screening endoscopy. * Had Clostridium difficile infection within 30 days of screening endoscopy or have a positive test result at screening, or other intestinal pathogen within 30 days before screening endoscopy. * Participant must not have signs of an ongoing infection related to an intestinal pathogen. * In the investigator's opinion, any clinically significant abnormalities of laboratory results from chemistry, hematology or urinalysis tests obtained at the screening visit that cannot be attributed to the underlying moderate-to-severe UC. * Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study. * History of a significant allergic reaction (anaphylaxis, urticaria) or significant sensitivity to study intervention or any constituents of the study interventions (including excipients). * Positive for hepatitis B or C, HIV (Human Immunodeficiency Virus), as assessed by method available at each site.
Where it's running
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GSK Investigational Site
Oxford, United Kingdom Recruiting
Study contacts
- Study coordinator: US GSK Clinical Trials Call Center
- Email: GSKClinicalSupportHD@gsk.com
- Phone: 877-379-3718
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.