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Aletekitug

Phase 1

Colitis, Ulcerative | Monoclonal antibody | Gastrointestinal |GSK plc|Last Updated: Aug 5, 2026

Target and mechanism

ModalityMonoclonal antibody

Also known as Aletekitug (GSK1070806)

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials2
Total Enrollment32

FDA Designations

No designations recorded

Clinical trial landscape

Aletekitug · 2 trials · 1 indication

Phase 1 2
NCT07747467A Study to Investigate the Safety and Tolerability of Multiple Study Interventions in Participants With Moderate to Severe Ulcerative ColitisColitis, Ulcerative
NOT YET_RECRUITING16 Analytics
NCT07747480A Sub Study to Investigate the Safety and Tolerability of Aletekitug in Participants With Moderate To Severe Ulcerative ColitisColitis, Ulcerative
NOT YET_RECRUITING16 Analytics
PHASE1NOT YET_RECRUITING
A Study to Investigate the Safety and Tolerability of Multiple Study Interventions in Participants With Moderate to Severe Ulcerative Colitis
Colitis, UlcerativeUnlock trial analytics
PHASE1NOT YET_RECRUITING
A Sub Study to Investigate the Safety and Tolerability of Aletekitug in Participants With Moderate To Severe Ulcerative Colitis
Colitis, UlcerativeUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of Participants with Adverse Events (AEs)
Up to 34 weeks

Adverse events will be collected.

Number of Participants with Serious AEs (SAEs)
Up to 34 weeks

Serious AEs will be collected.

Number of Participants who Discontinue Study Intervention due to AEs
Up to 34 weeks

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

Number of Participants with Clinically Significant Changes in Laboratory Readings
Up to 34 weeks

Hematology, clinical chemistry, and urinalysis will be collected.

Number of Participants with Clinically Significant Changes in Vital Signs
Up to 34 weeks

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

Number of Participants with Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Readings
Up to 34 weeks

ECG readings will be collected.

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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
AletekitugEXPERIMENTALParticipants will receive Aletekitug.
Aletekitug (GSK1070806)EXPERIMENTALParticipants will receive Aletekitug.

Interventions

NameTypeDescription
Aletekitug (GSK1070806)BIOLOGICALAletekitug will be administered.
AletekitugBIOLOGICALAletekitug will be administered.
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Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersNo

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...

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Recent Changes (Last 90 Days)

LOWAug 5, 2026NCT07747467NEW_TRIAL: changed
LOWAug 5, 2026NCT07747480NEW_TRIAL: changed

Frequently asked questions about Aletekitug

What is Aletekitug used for?

Aletekitug is an investigational monoclonal antibody being developed for the treatment of ulcerative colitis, specifically moderate to severe cases. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.

Who makes Aletekitug?

Aletekitug is being developed by GSK plc, a global biopharmaceutical company listed on the stock exchange under the ticker GSK. The drug is in early-stage clinical trials for ulcerative colitis.

What phase is Aletekitug in?

Aletekitug is in Phase 1 clinical development. It is an investigational drug, meaning it has not yet been approved for any use. Two Phase 1 trials are planned but have not yet started recruiting participants.

What clinical trials is Aletekitug in?

Aletekitug is involved in two Phase 1 trials: NCT07747467, a study of multiple interventions in moderate to severe ulcerative colitis, and NCT07747480, a substudy focusing on Aletekitug alone. Both trials are not yet recruiting and each plans to enroll 16 participants.

Is Aletekitug the same as GSK1070806?

Yes, Aletekitug is also known as GSK1070806. Both names refer to the same investigational monoclonal antibody being studied for ulcerative colitis.