Colitis, UlcerativePhase 1NCT07747480
A Sub Study to Investigate the Safety and Tolerability of Aletekitug in Participants With Moderate To Severe Ulcerative Colitis
A Phase 1 study testing Aletekitug in people with Colitis, Ulcerative, run by GlaxoSmithKline at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colitis, Ulcerative
- What is being tested?
- Aletekitug
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 3 Sep 2026to 5 Mar 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
- 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.
- Must meet contraception requirements if a female participant is a woman of childbearing potential (WOCBP)
Who cannot join
- 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
Show all 24Show fewer
- 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.
- Positive for hepatitis B or C, HIV (Human Immunodeficiency Virus), as assessed by method available at each site;
- Uncontrolled hypertension (i.e., blood pressure consistently measures >=140/90 millimeters of mercury (mmHg) while actively taking 1 or more antihypertensive medications).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
GSK Investigational Site
Oxford, OX3 7LE
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
About this study
Official title: 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
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.
- Conditions
- Colitis, Ulcerative
- Being tested
- Aletekitug
- Keywords
- Ulcerative Colitis, Anti-Interleukin-18 (anti-IL-18), Inflammatory bowel disease, Aletekitug, GSK1070806, Gastrointestinal Diseases
- Medical subject headings
- Colitis, Ulcerative, Inflammatory Bowel Diseases, Gastrointestinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AletekitugBiological
Also called GSK1070806
Aletekitug will be administered.
| Study group | Role | What they receive |
|---|---|---|
| Aletekitug (GSK1070806) | Experimental | Participants will receive Aletekitug. Receives: Biological: Aletekitug |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Adverse events (AEs)
Adverse events will be collected.
Measured: Up to 34 weeks [End of sub-study (EOSS)]
Number of Participants with Serious AEs (SAEs)
Serious AEs will be collected.
Measured: Up to 34 weeks (EOSS)
Number of Participants who Discontinue Study Intervention due to AEs
Participants who discontinue study intervention due to AEs will be reported.
Measured: Up to 34 weeks (EOSS)
Number of Participants with Clinically Significant Changes in Laboratory Readings
Hematology, clinical chemistry, and urinalysis will be collected.
Measured: Up to 34 weeks (EOSS)
Number of Participants with Clinically Significant Changes in Vital Signs
Blood pressure, temperature and pulse rate readings will be collected.
Measured: Up to 34 weeks (EOSS)
Number of Participants with Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Readings
ECGs readings will be collected.
Measured: Up to 34 weeks (EOSS)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2026
- Study start3 Sep 2026
- Primary completion5 Mar 2028 (estimated)
- Study completion5 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colitis, UlcerativeStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07747480
- Sponsor's protocol ID
- 300227 Sub-study 1
- Status last verified
- Nov 2026
- First submitted
- 31 Jul 2026
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07747480
- Acronym / sponsor ID
- 300227 Sub-study 1
- Conditions
- Colitis, Ulcerative
- Keywords
- Ulcerative Colitis, Anti-Interleukin-18 (anti-IL-18), Inflammatory bowel disease, Aletekitug, GSK1070806, Gastrointestinal Diseases
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 3 Sep 2026 (actual)
- Primary completion
- 5 Mar 2028 (estimated)
- Study completion
- 5 Mar 2028 (estimated)
- First posted
- 5 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Aletekitug (GSK1070806) | Experimental | Biological: AletekitugParticipants will receive Aletekitug. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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).
- 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).
Key exclusion criteria (24 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AletekitugAlso: GSK1070806Aletekitug will be administered. | Biological | Aletekitug (GSK1070806) |
Primary outcome
Number of Participants with Adverse events (AEs)
Time frame: Up to 34 weeks [End of sub-study (EOSS)]
Adverse events will be collected.
Number of Participants with Serious AEs (SAEs)
Time frame: Up to 34 weeks (EOSS)
Serious AEs will be collected.
Number of Participants who Discontinue Study Intervention due to AEs
Time frame: Up to 34 weeks (EOSS)
Participants who discontinue study intervention due to AEs will be reported.
Number of Participants with Clinically Significant Changes in Laboratory Readings
Time frame: Up to 34 weeks (EOSS)
Hematology, clinical chemistry, and urinalysis will be collected.
Number of Participants with Clinically Significant Changes in Vital Signs
Time frame: Up to 34 weeks (EOSS)
Blood pressure, temperature and pulse rate readings will be collected.
Number of Participants with Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Readings
Time frame: Up to 34 weeks (EOSS)
ECGs readings will be collected.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Individual participant dataSharing planned: 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
GSK Clinical Trials study director
GlaxoSmithKline
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Aletekitug in people with Colitis, Ulcerative, run by GlaxoSmithKline at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact US GSK Clinical Trials Call Center (877-379-3718, GSKClinicalSupportHD@gsk.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Adverse events (AEs) (time frame: Up to 34 weeks [End of sub-study (EOSS)]). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.