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Not yet recruitingNCT07747467PEGASUSUpdated Aug 5, 2026

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

A Phase 1 interventional study of Aletekitug (GSK1070806) in Colitis, Ulcerative, sponsored by GlaxoSmithKline. Not yet recruiting. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-08-05.

Sponsored by GlaxoSmithKline · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
16
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
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Study 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.

02

Conditions studied

  • Colitis, Ulcerative

Keywords

  • Ulcerative Colitis
  • Anti-Interleukin-18 (anti-IL-18)
  • Inflammatory bowel disease
  • aletekitug
  • GSK1070806
  • Gastrointestinal Diseases
03

In context

Colitis, Ulcerative

1,492 studies on the registry are indexed under Colitis, Ulcerative; 399 are open to participants now.

This study's planned enrollment of 16 is below the median of 71 across 1,042 interventional studies indexed under Colitis, Ulcerative.

Browse Colitis, Ulcerative studies →

Lead sponsor

GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.

Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
16 participants (estimated)

Study arms

  • Experimental
    Aletekitug

    Participants will receive Aletekitug.

    Biological: Aletekitug (GSK1070806)

Interventions

  • BiologicalAletekitug (GSK1070806)

    Aletekitug will be administered.

    Also known as: GSK1070806

06

What researchers measure

Primary outcomes

  1. Number of Participants with Adverse Events (AEs)

    Adverse events will be collected.

    Time frame: Up to 34 weeks

  2. Number of Participants with Serious AEs (SAEs)

    Serious AEs will be collected.

    Time frame: Up to 34 weeks

  3. Number of Participants who Discontinue Study Intervention due to AEs

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

    Time frame: Up to 34 weeks

  4. Number of Participants with Clinically Significant Changes in Laboratory Readings

    Hematology, clinical chemistry, and urinalysis will be collected.

    Time frame: Up to 34 weeks

  5. Number of Participants with Clinically Significant Changes in Vital Signs

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

    Time frame: Up to 34 weeks

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

    ECG readings will be collected.

    Time frame: Up to 34 weeks

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Yes — Study Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/gsk-patient-level-data-sharing-july2025.pdf

Supporting information: Study protocol, Sap, Icf, Csr

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 5, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07747467
Lead sponsor
GlaxoSmithKline
Responsible party
Sponsor
First posted
Aug 5, 2026
Start date
Aug 10, 2026 (estimated)
Primary completion
Jul 31, 2028 (estimated)
Completion
Dec 4, 2028 (estimated)
Last update
Aug 5, 2026

Study contacts

US GSK Clinical Trials Call Center
Contact
GSKClinicalSupportHD@gsk.com
877-379-3718
EU GSK Clinical Trials Call Center
Contact
GSKClinicalSupportHD@gsk.com
+44 (0) 20 89904466
GSK Clinical Trials
study director · GlaxoSmithKline

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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