A Study to Investigate the Safety and Tolerability of Multiple Study Interventions in Participants With Moderate to Severe Ulcerative Colitis

NCT07747467 | Not Yet Recruiting Phase 1

• 1 other identifier: 300227
• Study Type: interventional
• Target: 16
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Colitis, Ulcerative

Keywords

Ulcerative Colitis; Anti-Interleukin-18 (anti-IL-18); Inflammatory bowel disease; aletekitug; GSK1070806; Gastrointestinal Diseases

Outcome Measures

Primary Outcomes (6)

• Number of Participants with Adverse Events (AEs)

  Adverse events will be collected.

  Up to 34 weeks

• Number of Participants with Serious AEs (SAEs)

  Serious AEs will be collected.

  Up to 34 weeks

• Number of Participants who Discontinue Study Intervention due to AEs

  Participants who discontinue study intervention due to AEs will be reported.

  Up to 34 weeks

• Number of Participants with Clinically Significant Changes in Laboratory Readings

  Hematology, clinical chemistry, and urinalysis will be collected.

  Up to 34 weeks

• Number of Participants with Clinically Significant Changes in Vital Signs

  Blood pressure, temperature and pulse rate readings will be collected.

  Up to 34 weeks

• Number of Participants with Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Readings

  ECG readings will be collected.

  Up to 34 weeks

Study Arms (1)

Aletekitug

EXPERIMENTAL

Participants will receive Aletekitug.

Biological: Aletekitug (GSK1070806)

Interventions

Aletekitug (GSK1070806) BIOLOGICAL

Aletekitug will be administered.

Also known as: GSK1070806

Aletekitug

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

MeSH Terms

Conditions

Colitis, Ulcerative; Inflammatory Bowel Diseases; Gastrointestinal Diseases

Interventions

GSK1070806

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Digestive System Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Central Study Contacts

US GSK Clinical Trials Call Center

CONTACT

877-379-3718; GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Center

CONTACT

+44 (0) 20 89904466; GSKClinicalSupportHD@gsk.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Masking Details: The study will be open label.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2026
• First Posted: August 5, 2026
• Study Start: August 10, 2026
• Primary Completion (Estimated): July 31, 2028
• Study Completion (Estimated): December 4, 2028
• Last Updated: August 5, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or asset(s) with development terminated across all indications.
• Access Criteria: Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months, but an extension may be granted, when justified, for up to 6 months.