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Completed

NCT Number: NCT03134222

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

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).

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Key information

Conditions

Cutaneous Lupus Erythematosus Connective Tissue Diseases Lupus Erythematosus, Cutaneous Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Dermatology Ottawa Research Centre, Ottawa, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lanraplenib

Drug

30 mg tablets administered orally once daily with or without food

Other names: GS-9876

Filgotinib

Drug

200 mg tablets administered orally once daily with or without food

Other names: GS-6034

Lanraplenib placebo

Drug

Tablets administered orally once daily with or without food

Filgotinib placebo

Drug

Tablets administered orally once daily with or without food

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Gilead Sciences

Industry

Collaborators

  • Lakefront Biotherapeutics NV

Registry information

Official study 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)

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Apr 28, 2017
Registry last updated
Jun 9, 2020

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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