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
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.
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 →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.
Exclusion Criteria:
Have received any of the following for treatments of UC:
Participants will receive Aletekitug.
Biological: Aletekitug (GSK1070806)
Aletekitug will be administered.
Also known as: GSK1070806
Number of Participants with Adverse Events (AEs)
Adverse events will be collected.
Time frame: Up to 34 weeks
Number of Participants with Serious AEs (SAEs)
Serious AEs will be collected.
Time frame: 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.
Time frame: Up to 34 weeks
Number of Participants with Clinically Significant Changes in Laboratory Readings
Hematology, clinical chemistry, and urinalysis will be collected.
Time frame: Up to 34 weeks
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
Number of Participants with Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Readings
ECG readings will be collected.
Time frame: Up to 34 weeks
No study locations are listed for this record.
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.
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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GlaxoSmithKline