Study to Evaluate Safety and Efficacy of Filgotinib and Lanraplenib in Females With Moderately-to-Severely Active Cutaneous Lupus Erythematosus (CLE)

• ClinicalTrials.gov Identifier: NCT03134222
• Recruitment Status: Completed
• First Posted: April 28, 2017
• Results First Posted: April 8, 2020
• Last Update Posted: June 9, 2020
• Sponsor: Gilead Sciences
• Collaborator: Galapagos NV
• Information provided by (Responsible Party): Gilead Sciences

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Cutaneous Lupus Erythematosus	Drug: Lanraplenib; Drug: Filgotinib; Drug: Lanraplenib placebo; Drug: Filgotinib placebo	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 47 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• 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
• Actual Primary Completion Date: March 13, 2019
• Actual Study Completion Date: December 18, 2019

Arms and Interventions

Arm	Intervention/treatment
Experimental: Lanraplenib 30 mg; Lanraplenib + filgotinib placebo for 48 weeks	Drug: Lanraplenib; 30 mg tablets administered orally once daily with or without food; Other Name: GS-9876; Drug: Filgotinib placebo; Tablets administered orally once daily with or without food
Experimental: Filgotinib 200 mg; Filgotinib + lanraplenib placebo for 48 weeks	Drug: Filgotinib; 200 mg tablets administered orally once daily with or without food; Other Name: GS-6034; Drug: Lanraplenib placebo; Tablets administered orally once daily with or without food
Placebo Comparator: Placebo; Filgotinib placebo + lanraplenib placebo for 12 weeks	Drug: Lanraplenib placebo; Tablets administered orally once daily with or without food; Drug: Filgotinib placebo; Tablets administered orally once daily with or without food
Experimental: Placebo to Lanraplenib 30 mg; After Week 12 Visit, participants on placebo will be rerandomized 1:1 and receive lanraplenib + filgotinib placebo in a blinded fashion through Week 48.	Drug: Lanraplenib; 30 mg tablets administered orally once daily with or without food; Other Name: GS-9876; Drug: Filgotinib placebo; Tablets administered orally once daily with or without food
Experimental: Placebo to Filgotinib 200 mg; After Week 12 Visit, participants on placebo will be rerandomized 1:1 and receive filgotinib + lanraplenib placebo in a blinded fashion through Week 48.	Drug: Filgotinib; 200 mg tablets administered orally once daily with or without food; Other Name: GS-6034; Drug: Lanraplenib placebo; Tablets administered orally once daily with or without food

Outcome Measures

Primary Outcome Measures :

1. Change in Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) Activity Score From Baseline to Week 12 [ Time Frame: Baseline; Week 12 ]
   CLASI Activity is scored based on erythema, scale/hyperkeratosis, mucous membrane involvement, acute hair loss and nonscarring alopecia. Evaluation of erythema and scale/hyperkeratosis is based on a table: rows represent anatomical areas and columns represent major clinical symptoms. The extent of involvement for each of the skin symptoms is documented for each anatomic area. The total score ranges from 0-70, with higher scores indicating more severe skin disease.

Secondary Outcome Measures :

1. Percentage of Participants at Week 12 With Decrease of ≥ 5 Points in CLASI Activity Score From Baseline [ Time Frame: Baseline; Week 12 ]
   CLASI Activity is scored based on erythema, scale/hyperkeratosis, mucous membrane involvement, acute hair loss and nonscarring alopecia. Evaluation of erythema and scale/hyperkeratosis is based on a table: rows represent anatomical areas and columns represent major clinical symptoms. The extent of involvement for each of the skin symptoms is documented for each anatomic area. The total score ranges from 0-70, with higher scores indicating more severe skin disease.
2. Percentage of Participants at Week 12 With No Worsening in CLASI Activity Score From Baseline [ Time Frame: Baseline; Week 12 ]
   CLASI Activity is scored based on erythema, scale/hyperkeratosis, mucous membrane involvement, acute hair loss and nonscarring alopecia. Evaluation of erythema and scale/hyperkeratosis is based on a table: rows represent anatomical areas and columns represent major clinical symptoms. The extent of involvement for each of the skin symptoms is documented for each anatomic area. The total score ranges from 0-70, with higher scores indicating more severe skin disease. Worsening was defined as ≥ 3 point increase in CLASI activity score.
3. Percentage of Participants at Week 24 With Decrease of ≥ 5 Points in CLASI Activity Score From Baseline [ Time Frame: Baseline; Week 24 ]
   CLASI Activity is scored based on erythema, scale/hyperkeratosis, mucous membrane involvement, acute hair loss and nonscarring alopecia. Evaluation of erythema and scale/hyperkeratosis is based on a table: rows represent anatomical areas and columns represent major clinical symptoms. The extent of involvement for each of the skin symptoms is documented for each anatomic area. The total score ranges from 0-70, with higher scores indicating more severe skin disease.
4. Percentage of Participants at Week 24 With No Worsening in CLASI Activity Score From Baseline [ Time Frame: Baseline; Week 24 ]
   CLASI Activity is scored based on erythema, scale/hyperkeratosis, mucous membrane involvement, acute hair loss and nonscarring alopecia. Evaluation of erythema and scale/hyperkeratosis is based on a table: rows represent anatomical areas and columns represent major clinical symptoms. The extent of involvement for each of the skin symptoms is documented for each anatomic area. The total score ranges from 0-70, with higher scores indicating more severe skin disease. Worsening was defined as ≥ 3 point increase in CLASI activity score.

Eligibility Criteria

• 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 (e.g., discoid) or subacute CLE per investigator evaluation, with the following:

  • Moderately-to-severely active CLE (Cutaneous lupus erythematosus disease area and severity index [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.

Contacts and Locations

Locations

United States, California

Wallace Rheumatic Studies Center

Beverly Hills, California, United States, 90211

St. Jude Hospital Yorba Linda DBA Dr. Joseph Heritage Healthcare

Fullerton, California, United States, 92835

Dermatology Research Associates

Los Angeles, California, United States, 90045

Desert Medical Advances

Palm Desert, California, United States, 92260

Medderm Associates

San Diego, California, United States, 92103

Inland Rheumatology Clinical Trials

Upland, California, United States, 91786

United States, Florida

Clinical Research of West Florida, Inc.

Clearwater, Florida, United States, 33765

Omega Research Consultants LLC

DeBary, Florida, United States, 32713

United States, North Carolina

DJL Clinical Research, PLLC

Charlotte, North Carolina, United States, 28210

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States, 27104

United States, Pennsylvania

Penn State Hershey Medical Center

Hershey, Pennsylvania, United States, 17033

University of Pennsylvania

Philadelphia, Pennsylvania, United States, 19104

United States, Texas

Metroplex Clinical Research Center

Dallas, Texas, United States, 75231

Canada

Dermatology Ottawa Research Centre

Ottawa, Canada, K2C 3N2

University Health Network (UHN) - Toronto Western Hospital

Toronto, Canada, M5T 2S8

K.Papp Clinical Research

Waterloo, Canada, N2J 1C4

Sponsors and Collaborators

Gilead Sciences

Galapagos NV

Investigators

• Study Director: Gilead Study Director; Gilead Sciences

  Study Documents (Full-Text)

Documents provided by Gilead Sciences:

Study Protocol  [PDF] October 15, 2018

Statistical Analysis Plan  [PDF] May 13, 2019

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Werth VP, Fleischmann R, Robern M, Touma Z, Tiamiyu I, Gurtovaya O, Pechonkina A, Mozaffarian A, Downie B, Matzkies F, Wallace D. Filgotinib or lanraplenib in moderate to severe cutaneous lupus erythematosus: a phase 2, randomized, double-blind, placebo-controlled study. Rheumatology (Oxford). 2022 May 30;61(6):2413-2423. doi: 10.1093/rheumatology/keab685.

• Responsible Party: Gilead Sciences
• ClinicalTrials.gov Identifier: NCT03134222
• Other Study ID Numbers: GS-US-436-4092
• First Posted: April 28, 2017
• Results First Posted: April 8, 2020
• Last Update Posted: June 9, 2020
• Last Verified: June 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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