Trial · NCT03134222

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

NCT03134222, Phase 2, Completed, Gilead Sciences; results first posted 2020-04-08

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Study to Evaluate Safety and Efficacy of Filgotinib and Lanraplenib in Females With Moderately-to-Severely Active Cutaneous Lupus Erythematosus (CLE). Trials, record NCT03134222. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03134222

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Study to Evaluate Safety and Efficacy of Filgotinib and Lanraplenib in Females With Moderately-to-Severely Active Cutaneous Lupus Erythematosus (CLE)
NCT number: NCT03134222
Status: Completed
Phases: Phase 2
Enrollment: 47 participants, actual
Lead sponsor: Gilead Sciences
Conditions: Cutaneous Lupus Erythematosus
Interventions: Lanraplenib, Filgotinib, Lanraplenib placebo, Filgotinib placebo
First posted: 2017-04-28
Last updated: 2020-06-09
Results first posted: 2020-04-08

Source ClinicalTrials.gov

Registered outcomes5

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change in Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) Activity Score From Baseline to Week 12	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	Percentage of Participants at Week 12 With Decrease of ≥ 5 Points in CLASI Activity Score From Baseline	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	Percentage of Participants at Week 12 With No Worsening in CLASI Activity Score From Baseline	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.
Secondary	Percentage of Participants at Week 24 With Decrease of ≥ 5 Points in CLASI Activity Score From Baseline	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.
Secondary	Percentage of Participants at Week 24 With No Worsening in CLASI Activity Score From Baseline	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.

Source ClinicalTrials.gov

Outcomes5

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change in Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) Activity Score From Baseline to Week 12	Baseline; Week 12	Treatment policy-estimand is the primary estimand for the primary endpoint analysis which involved participants in the Full Analysis Set (who were randomized and received at least one dose of study drug \[filgotinib, lanraplenib or placebo\]) with available data.	score on a scale	LEAST_SQUARES_MEAN
SECONDARY	Percentage of Participants at Week 12 With Decrease of ≥ 5 Points in CLASI Activity Score From Baseline	Baseline; Week 12	Participants in the Full Analysis Set were analyzed. Missing data are imputed as No Response.	Percentage of participants	NUMBER
SECONDARY	Percentage of Participants at Week 12 With No Worsening in CLASI Activity Score From Baseline	Baseline; Week 12	Participants in the Full Analysis Set were analyzed. Missing data are imputed as No Response.	Percentage of participants	NUMBER
SECONDARY	Percentage of Participants at Week 24 With Decrease of ≥ 5 Points in CLASI Activity Score From Baseline	Baseline; Week 24	Participants in the Full Analysis Set who were randomized to Filgotinib 200 mg or Lanraplenib 200 mg.	Percentage of participants	NUMBER
SECONDARY	Percentage of Participants at Week 24 With No Worsening in CLASI Activity Score From Baseline	Baseline; Week 24	Participants in the Full Analysis Set who were randomized to Filgotinib 200 mg or Lanraplenib 200 mg.	Percentage of participants	NUMBER

Source ClinicalTrials.gov

Results by group13

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Change in Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) Activity Score From Baseline to Week 12	Lanraplenib 30 mg	-4.5	Standard Error 1.91	score on a scale
Change in Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) Activity Score From Baseline to Week 12	Filgotinib 200 mg	-8.7	Standard Error 1.85	score on a scale
Change in Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) Activity Score From Baseline to Week 12	Placebo	-5.5	Standard Error 2.56	score on a scale
Percentage of Participants at Week 12 With Decrease of ≥ 5 Points in CLASI Activity Score From Baseline	Lanraplenib 30 mg	47.4	95% Confidence Interval 24.4 to 71.1	Percentage of participants
Percentage of Participants at Week 12 With Decrease of ≥ 5 Points in CLASI Activity Score From Baseline	Filgotinib 200 mg	64.7	95% Confidence Interval 38.3 to 85.8	Percentage of participants
Percentage of Participants at Week 12 With Decrease of ≥ 5 Points in CLASI Activity Score From Baseline	Placebo	44.4	95% Confidence Interval 13.7 to 78.8	Percentage of participants
Percentage of Participants at Week 12 With No Worsening in CLASI Activity Score From Baseline	Lanraplenib 30 mg	84.2	95% Confidence Interval 60.4 to 96.6	Percentage of participants
Percentage of Participants at Week 12 With No Worsening in CLASI Activity Score From Baseline	Filgotinib 200 mg	94.1	95% Confidence Interval 71.3 to 99.9	Percentage of participants
Percentage of Participants at Week 12 With No Worsening in CLASI Activity Score From Baseline	Placebo	88.9	95% Confidence Interval 51.8 to 99.7	Percentage of participants
Percentage of Participants at Week 24 With Decrease of ≥ 5 Points in CLASI Activity Score From Baseline	Lanraplenib 30 mg	50.0	95% Confidence Interval 23.0 to 77.0	Percentage of participants

1 to 10 of 13Source ClinicalTrials.gov

See all 13 results by group

Participant flow30

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Treatment Period (Up to Week 12)	STARTED	Lanraplenib 30 mg	19
Treatment Period (Up to Week 12)	STARTED	Filgotinib 200 mg	18
Treatment Period (Up to Week 12)	STARTED	Placebo	10
Treatment Period (Up to Week 12)	STARTED	Placebo to Lanraplenib 30 mg	0
Treatment Period (Up to Week 12)	STARTED	Placebo to Filgotinib 200 mg	0
Treatment Period (Up to Week 12)	COMPLETED	Lanraplenib 30 mg	14
Treatment Period (Up to Week 12)	COMPLETED	Filgotinib 200 mg	14
Treatment Period (Up to Week 12)	COMPLETED	Placebo	8
Treatment Period (Up to Week 12)	COMPLETED	Placebo to Lanraplenib 30 mg	0
Treatment Period (Up to Week 12)	COMPLETED	Placebo to Filgotinib 200 mg	0

1 to 10 of 30Source ClinicalTrials.gov

See all 30 participant flow

Adverse events455

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Anaemia	Blood and lymphatic system disorders	Lanraplenib 30 mg	1	19
other	Anaemia	Blood and lymphatic system disorders	Filgotinib 200 mg	0	17
other	Anaemia	Blood and lymphatic system disorders	Placebo	0	9
other	Anaemia	Blood and lymphatic system disorders	Placebo to Lanraplenib 30 mg	0	4
other	Anaemia	Blood and lymphatic system disorders	Placebo to Filgotinib 200 mg	0	4
other	Lymphopenia	Blood and lymphatic system disorders	Lanraplenib 30 mg	1	19
other	Lymphopenia	Blood and lymphatic system disorders	Filgotinib 200 mg	1	17
other	Lymphopenia	Blood and lymphatic system disorders	Placebo	0	9
other	Lymphopenia	Blood and lymphatic system disorders	Placebo to Lanraplenib 30 mg	0	4
other	Lymphopenia	Blood and lymphatic system disorders	Placebo to Filgotinib 200 mg	0	4

1 to 10 of 455Source ClinicalTrials.gov

See all 455 adverse events

Adverse event totals15

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Lanraplenib 30 mg	0	19
Total, all-cause mortality	Filgotinib 200 mg	0	17
Total, all-cause mortality	Placebo	0	9
Total, all-cause mortality	Placebo to Lanraplenib 30 mg	0	4
Total, all-cause mortality	Placebo to Filgotinib 200 mg	0	4
Total, other adverse events	Lanraplenib 30 mg	17	19
Total, other adverse events	Filgotinib 200 mg	11	17
Total, other adverse events	Placebo	6	9
Total, other adverse events	Placebo to Lanraplenib 30 mg	3	4
Total, other adverse events	Placebo to Filgotinib 200 mg	3	4

1 to 10 of 15Source ClinicalTrials.gov

See all 15 adverse event totals

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
34498056	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT03134222

GET https://conductscience.org/api/trials/v1/NCT03134222/flow?page=2

API reference For AI assistants