Aletekitug
BiologicalAletekitug will be administered.
Other names: GSK1070806
NCT Number: NCT07747480
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.
Trial opening soon.
Get Notified18 year–75 year
All sexes
Interventional
Phase 1
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Aletekitug will be administered.
Other names: GSK1070806
Time frame: Up to 34 weeks [End of sub-study (EOSS)]
Adverse events will be collected.
Time frame: Up to 34 weeks (EOSS)
Serious AEs will be collected.
Time frame: Up to 34 weeks (EOSS)
Participants who discontinue study intervention due to AEs will be reported.
Time frame: Up to 34 weeks (EOSS)
Hematology, clinical chemistry, and urinalysis will be collected.
Time frame: Up to 34 weeks (EOSS)
Blood pressure, temperature and pulse rate readings will be collected.
Time frame: Up to 34 weeks (EOSS)
ECGs readings will be collected.
Contact information is provided by the study sponsor or research team.
EU GSK Clinical Trials Call Center
CONTACT
US GSK Clinical Trials Call Center
CONTACT
GlaxoSmithKline
Industry
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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