Study to Evaluate the Efficacy and Safety of GS-4875 in Adults With Moderately to Severely Active Ulcerative Colitis

Study Purpose

The primary objective of this study is to demonstrate the efficacy of GS-4875 compared with placebo control in achieving clinical remission per modified Mayo Clinic score (MCS) in adults with moderately to severely active ulcerative colitis (UC).

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

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.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - 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.
Documentation of endoscopy and histology consistent with the diagnosis of UC must be available in the source documents prior to the initiation of screening.
  • - 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).
The induction treatment regimen resulting in inadequate response or loss of response should have been in accordance with local prescribing information/guidelines or as outlined below.
  • - 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.
OR
  • - A history of fully treated active or latent TB according to local standard of care.
Investigator must verify adequate previous anti-TB treatment and provide documentation; these individuals do not require QuantiFERON testing and eligibility must be approved by the sponsor prior to enrollment in the study. AND
  • - 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.

Trial Details

Trial ID:

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.

NCT04130919
Phase

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.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Gilead Sciences
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Gilead Study Director
Principal Investigator Affiliation Gilead Sciences
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Ulcerative Colitis
Arms & Interventions

Arms

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.

Interventions

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.

United Medical Doctors, Murrieta, California

Status

Recruiting

Address

United Medical Doctors

Murrieta, California, 92563

Alliance Medical Research, Coral Springs, Florida

Status

Recruiting

Address

Alliance Medical Research

Coral Springs, Florida, 33071

Encore Borland-Groover Clinical Research, Jacksonville, Florida

Status

Recruiting

Address

Encore Borland-Groover Clinical Research

Jacksonville, Florida, 32256

BRCR Medical Center Inc., Plantation, Florida

Status

Recruiting

Address

BRCR Medical Center Inc.

Plantation, Florida, 33322

Advanced Medical Research Center, Port Orange, Florida

Status

Recruiting

Address

Advanced Medical Research Center

Port Orange, Florida, 32127

Gastrointestinal Specialists of Georgia, Marietta, Georgia

Status

Recruiting

Address

Gastrointestinal Specialists of Georgia

Marietta, Georgia, 30060

Atlanta Gastroenterology Specialists, PC, Suwanee, Georgia

Status

Recruiting

Address

Atlanta Gastroenterology Specialists, PC

Suwanee, Georgia, 30024

Louisiana Research Center, LLC, Shreveport, Louisiana

Status

Recruiting

Address

Louisiana Research Center, LLC

Shreveport, Louisiana, 71105

Kansas City Research Institute, Kansas City, Missouri

Status

Recruiting

Address

Kansas City Research Institute

Kansas City, Missouri, 64131

Advanced Biomedical Research of America, Las Vegas, Nevada

Status

Recruiting

Address

Advanced Biomedical Research of America

Las Vegas, Nevada, 89123

Orangeburg, South Carolina

Status

Recruiting

Address

Gastroenterology Associates of Orangeburg

Orangeburg, South Carolina, 29118

San Antonio, Texas

Status

Recruiting

Address

Clinical Associates in Research Therapeutics of America, LLC

San Antonio, Texas, 78212

Texas Digestive Disease Consultants, San Marcos, Texas

Status

Recruiting

Address

Texas Digestive Disease Consultants

San Marcos, Texas, 78666

Texas Digestive Disease Consultants, Southlake, Texas

Status

Recruiting

Address

Texas Digestive Disease Consultants

Southlake, Texas, 76092

Allegiance Research Specialists, LLC, Wauwatosa, Wisconsin

Status

Recruiting

Address

Allegiance Research Specialists, LLC

Wauwatosa, Wisconsin, 53225

The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation. For a full description of terms please refer to our Terms, Conditions & Privacy.