Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||18 Years and Over|
- - Males, or non-pregnant, non-lactating females, at least 18 years of age based on the date of the screening visit.
- - UC of at least 3 months duration before randomization confirmed by endoscopy and histology at any time in the past AND a minimum disease extent of 15 cm from the anal verge.
- - Moderately to severely active UC as determined during screening by a centrally read endoscopy score ≥ 2, a Rectal Bleeding subscore ≥ 1, a Stool Frequency subscore ≥ 1 and Physicians Global Assessment (PGA) of ≥ 2 as defined by the Mayo Clinic Score; total MCS must be between 6 and 12, inclusive.
- - Previously demonstrated an inadequate response (primary non-response) or loss of response (secondary non-response) to a tumor necrosis factor-alpha (TNFα) inhibitor (ie, infliximab, adalimumab, golimumab, or biosimilars).
- - Infliximab: 5 mg/kg at Weeks 0, 2, and 6 - Adalimumab: 160 mg on Day 1 (given in 1 day or split over consecutive days), followed by 80 mg 2 weeks later (Day 15), 40 mg 2 weeks later (Day 29) and every 2 weeks thereafter until Day 57 - Golimumab: 200 mg on Day 1 followed by 100 mg at Week 2 - May be receiving concomitant therapy for UC at the time of enrollment as specified in the protocol, provided the dose prescribed has been stable as indicated prior to randomization.
- - Meet the following Tuberculosis (TB) screening criteria: - No evidence of active TB, latent TB, or inadequately treated TB as evidenced by 1 of the following: - A negative QuantiFERON test or equivalent assay reported by the central lab at screening or within 90 days prior to randomization date.
- - A history of fully treated active or latent TB according to local standard of care.
- - A chest radiograph (views as per local guidelines with the report or films available for investigator review) taken at screening or within the 4 months prior to randomization without evidence of active or latent TB infection.
- - Laboratory assessments at screening within the following parameters: - Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) and total bilirubin ≤ 2 X ULN (upper limit of normal) - Estimated glomerular filtration rate (eGFR) ≥ 60 ml/min (1.0 mL/sec) as calculated by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) Cystatin C formula as described in protocol.
- - Hemoglobin ≥ 8 g/dL (≥ 80 g/L)
- Absolute neutrophil count (ANC) ≥ 1.5 × 10^3/μL (≥ 1.5 GI/L)
- Platelets ≥ 100 × 10^3/μL (≥ 100 GI/L)
- White blood cells (WBC) ≥ 3 × 10^3/μL (≥ 3 GI/L)
- Absolute lymphocyte count ≥ 0.75 × 10^3/μL (≥ 0.75 GI/L)
Exclusion Criteria:- Currently displaying clinical signs of acute severe colitis, fulminant colitis, or toxic megacolon.
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Gilead Study Director|
|Principal Investigator Affiliation||Gilead Sciences|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
Experimental: GS-4875 300 mg
Participants will receive blinded GS-4875 300 mg for up to 10 weeks. An efficacy assessment will be performed at Week 10. Participants who achieve MCS response will continue on the blinded treatment for up to 50 weeks.
Experimental: GS-4875 100 mg
Participants will receive blinded GS-4875 100 mg for up to 10 weeks. An efficacy assessment will be performed at Week 10. Participants who achieve MCS response will continue on the blinded treatment for up to 50 weeks.
Placebo Comparator: Placebo
Participants will receive blinded GS-4875 placebo for up to 10 weeks. An efficacy assessment will be performed at Week 10. Participants who achieve MCS response will continue on the blinded treatment for up to 50 weeks.
Experimental: Open-label Treatment Phase
Based on the efficacy assessment results at Week 10, participants who do not achieve MCS response will have the option to receive open-label GS-4875 300 mg for up to 50 weeks.
Drug: - GS-4875
Tablets administered orally once daily
Drug: - Placebo
Tablets administered orally once daily
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.