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Trial record 3 of 133 for:    Lupus AND (woman OR women OR female)

Safety and Efficacy of Filgotinib and GS-9876 in Females With Moderately-to-Severely Active Cutaneous Lupus Erythematosus (CLE)

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ClinicalTrials.gov Identifier: NCT03134222
Recruitment Status : Recruiting
First Posted : April 28, 2017
Last Update Posted : July 20, 2018
Sponsor:
Collaborator:
Galapagos NV
Information provided by (Responsible Party):
Gilead Sciences

Brief Summary:
The primary objective of this study is to evaluate the efficacy of filgotinib and GS-9876 in females with moderately-to-severely active cutaneous lupus erythematosus (CLE).

Condition or disease Intervention/treatment Phase
Cutaneous Lupus Erythematosus Drug: Filgotinib Drug: GS-9876 Drug: Filgotinib placebo Drug: GS-9876 placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Assess the Safety and Efficacy of Filgotinib and GS-9876 in Female Subjects With Moderately-to-Severely Active Cutaneous Lupus Erythematosus (CLE)
Actual Study Start Date : May 24, 2017
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Filgotinib
Filgotinib 200 mg + GS-9876 placebo for 24 weeks
Drug: Filgotinib
200 mg tablets administered orally once daily with or without food

Drug: GS-9876 placebo
Tablets administered orally once daily with or without food

Experimental: GS-9876
GS-9876 30 mg + filgotinib placebo for 24 weeks
Drug: GS-9876
30 mg tablets administered orally once daily with or without food

Drug: Filgotinib placebo
Tablets administered orally once daily with or without food

Placebo Comparator: Placebo
Placebo for 12 weeks, then participants will be re-randomized to receive filgotinib 200 mg + GS-9876 placebo or GS-9876 30 mg + filgotinib placebo through Week 24.
Drug: Filgotinib
200 mg tablets administered orally once daily with or without food

Drug: GS-9876
30 mg tablets administered orally once daily with or without food

Drug: Filgotinib placebo
Tablets administered orally once daily with or without food

Drug: GS-9876 placebo
Tablets administered orally once daily with or without food

Experimental: Extension Period
Participants who have not permanently discontinued study drug during the first 24 weeks may enter the subsequent 24-week extension period where they will continue to receive their assigned dose of study drug, in a blinded fashion.
Drug: Filgotinib
200 mg tablets administered orally once daily with or without food

Drug: GS-9876
30 mg tablets administered orally once daily with or without food

Drug: Filgotinib placebo
Tablets administered orally once daily with or without food

Drug: GS-9876 placebo
Tablets administered orally once daily with or without food




Primary Outcome Measures :
  1. Change from Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) Activity Score from Baseline to Week 12 [ Time Frame: Baseline; Week 12 ]
    CLASI activity score measures disease activity, with higher scores indicating more severe disease.


Secondary Outcome Measures :
  1. Proportion of Participants at Week 12 with Decrease of ≥ 5 Points in CLASI Activity Score from Baseline [ Time Frame: Baseline; Week 12 ]
    CLASI activity score measures disease activity, with higher scores indicating more severe disease.

  2. Proportion of Participants at Week 12 with No Worsening in CLASI Activity Score from Baseline [ Time Frame: Baseline; Week 12 ]
    CLASI activity score measures disease activity, with higher scores indicating more severe disease. Worsening was defined as ≥ 3 point increase in CLASI activity score.

  3. Proportion of Participants at Week 24 with Decrease of ≥ 5 Points in CLASI Activity Score from Baseline [ Time Frame: Baseline; Week 24 ]
    CLASI activity score measures disease activity, with higher scores indicating more severe disease.

  4. Proportion of Participants at Week 24 with No Worsening in CLASI Activity Score from Baseline [ Time Frame: Baseline; Week 24 ]
    CLASI activity score measures disease activity, with higher scores indicating more severe disease. Worsening was defined as ≥ 3 point increase in CLASI activity score.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • Must have a diagnosis of CLE, either chronic (eg, discoid) or subacute CLE per investigator evaluation, with the following:

    • Moderately-to-severely active CLE (CLASI activity score ≥ 10) at screening and Day 1
    • Prior intolerance or inadequate response to at least one of the listed medications for the treatment of CLE
  • Stable dose (defined as no change in prescription for at least 28 days prior to Day 1) of antimalarials and/or topical or oral corticosteroids is permitted during the study. Individuals who are not planning to continue these medications during the study must have discontinued them at least 28 days prior to Day 1

Key Exclusion Criteria:

  • Use of prohibited concomitant medications per study protocol

Note: Other protocol defined Inclusion/Exclusion criteria may apply.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03134222


Contacts
Contact: Gilead Clinical Study Information Center 1-833-445-3230 (GILEAD-0) GileadClinicalTrials@gilead.com

Locations
United States, California
Wallace Rheumatic Studies Center Recruiting
Beverly Hills, California, United States, 90211
Contact: Daniel Wallace    310-360-9197      
St. Joseph Heritage Healthcare Recruiting
Fullerton, California, United States, 92835
Contact: Shirley Pang    714-833-4831      
Dermatology Research Associates Recruiting
Los Angeles, California, United States, 90045
Contact: Howard Sofen    310-337-7171      
Desert Medical Advances Active, not recruiting
Palm Desert, California, United States, 92260
Medderm Associates Recruiting
San Diego, California, United States, 92103
Contact: Michelle Pelle    619-542-0013      
Robin K. Dore MD Inc. Recruiting
Tustin, California, United States, 92780
Contact: Robin Dore    714-505-5500      
Inland Rheumatology Clinical Trials Recruiting
Upland, California, United States, 91786
Contact: Eric Lee    909-296-8700      
United States, Colorado
Denver Arthritis Clinic Withdrawn
Denver, Colorado, United States, 80230
United States, Florida
Clinical Research of West Florida, Inc. Recruiting
Clearwater, Florida, United States, 33765
Contact: Robert Levin    727-466-0078      
Omega Research Consultants LLC Recruiting
DeBary, Florida, United States, 32713
Contact: Sanjiv Kapil    386-668-4202      
Rheumatology Associates of Central Florida, P.A. Recruiting
Orlando, Florida, United States, 32806
Contact: Pamela Freeman    407-859-4540 ext 124      
Lovelace Scientific Resources, Inc. Recruiting
Sarasota, Florida, United States, 34233
Contact: Jeffrey Kaine    941-485-8314      
United States, Illinois
Northwestern University Recruiting
Chicago, Illinois, United States, 60611
Contact: Anne Laumann    312-695-8106      
United States, Michigan
Beals Institute PC Recruiting
Lansing, Michigan, United States, 48917
Contact: Patricia Cagnoli    517-886-5466      
United States, North Carolina
DJL Clinical Research, PLLC Recruiting
Charlotte, North Carolina, United States, 28210
Contact: Emily Jane Herron Box    704-247-9179      
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Jennifer Rogers    919-681-7405      
PMG Wilmington Recruiting
Wilmington, North Carolina, United States, 28401
Contact: Ronald George    910-815-6108      
Wake Forest University Health Sciences Recruiting
Winston-Salem, North Carolina, United States, 27104
Contact: William Huang    336-716-3775      
United States, Pennsylvania
Penn State Hershey Medical Center Recruiting
Hershey, Pennsylvania, United States, 17033
Contact: Galen Foulke    717-531-1513      
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Victoria Werth    215-615-2940      
United States, South Carolina
Low Country Rheumatology Recruiting
Charleston, South Carolina, United States, 29406
Contact: William Edwards    843-572-1818      
United States, Texas
Metroplex Clinical Research Center Recruiting
Dallas, Texas, United States, 75231
Contact: Roy Fleischmann    214-879-6737      
Canada
Office of Dr. Michael Robern Recruiting
Ottawa, Canada, K2G 6E2
Contact: Michael Robern    613-688-0545      
University Health Network (UHN) - Toronto Western Hospital Recruiting
Toronto, Canada, M5T 2S8
Contact: Zahi Touma    (416) 603-5248      
K.Papp Clinical Research Recruiting
Waterloo, Canada, N2J 1C4
Contact: Kim Papp    519-579-9535      
Sponsors and Collaborators
Gilead Sciences
Galapagos NV
Investigators
Study Director: Gilead Study Director Gilead Sciences

Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT03134222     History of Changes
Other Study ID Numbers: GS-US-436-4092
First Posted: April 28, 2017    Key Record Dates
Last Update Posted: July 20, 2018
Last Verified: July 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Lupus Erythematosus, Systemic
Lupus Erythematosus, Cutaneous
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Skin Diseases