Cutaneous Lupus ErythematosusPhase 2NCT03134222

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

A Phase 2 study testing Lanraplenib and Filgotinib in people with Cutaneous Lupus Erythematosus, run by Gilead Sciences at 16 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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). Read more about this study

Who is it for?: Ages 18 to 75 years, women only
Conditions the study is for: Cutaneous Lupus Erythematosus
What is being tested?: Lanraplenib and Filgotinib
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 47 participants
Where: 16 sitesin 2 countries
Study dates: 24 May 2017to 18 Dec 2019
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

Use of prohibited concomitant medications per study protocol
Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Trial locations and contacts

16 sites in 2 countries.

Country

City, postcode or hospital

16 sites in 2 countries

United States13 sites

Wallace Rheumatic Studies Center
Beverly Hills, California, 90211
DJL Clinical Research, PLLC
Charlotte, North Carolina, 28210
Clinical Research of West Florida, Inc.
Clearwater, Florida, 33765
Metroplex Clinical Research Center
Dallas, Texas, 75231
Omega Research Consultants LLC
DeBary, Florida, 32713
St. Jude Hospital Yorba Linda DBA Dr. Joseph Heritage Healthcare
Fullerton, California, 92835
Penn State Hershey Medical Center
Hershey, Pennsylvania, 17033
Dermatology Research Associates
Los Angeles, California, 90045
Desert Medical Advances
Palm Desert, California, 92260
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Medderm Associates
San Diego, California, 92103
Inland Rheumatology Clinical Trials
Upland, California, 91786
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27104

Other trials in United States

Canada3 sites

Dermatology Ottawa Research Centre
Ottawa, K2C 3N2
University Health Network (UHN) - Toronto Western Hospital
Toronto, M5T 2S8
K.Papp Clinical Research
Waterloo, N2J 1C4

Other trials in Canada

About this study

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)

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).

Conditions: Cutaneous Lupus Erythematosus
Being tested: Lanraplenib, Filgotinib, Lanraplenib placebo, Filgotinib placebo
Medical subject headings: Lupus Erythematosus, Cutaneous

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LanraplenibDrug
Also called GS-9876
30 mg tablets administered orally once daily with or without food
FilgotinibDrug
Also called GS-6034
200 mg tablets administered orally once daily with or without food
Lanraplenib placeboDrug
Tablets administered orally once daily with or without food
Filgotinib placeboDrug
Tablets administered orally once daily with or without food

Study groups in NCT03134222
Study group	Role	What they receive
Lanraplenib 30 mg	Experimental	Lanraplenib + filgotinib placebo for 48 weeks Receives: Drug: Lanraplenib; Drug: Filgotinib placebo
Filgotinib 200 mg	Experimental	Filgotinib + lanraplenib placebo for 48 weeks Receives: Drug: Filgotinib; Drug: Lanraplenib placebo
Placebo	Placebo comparator	Filgotinib placebo + lanraplenib placebo for 12 weeks Receives: Drug: Lanraplenib placebo; Drug: Filgotinib placebo
Placebo to Lanraplenib 30 mg	Experimental	After Week 12 Visit, participants on placebo will be rerandomized 1:1 and receive lanraplenib + filgotinib placebo in a blinded fashion through Week 48. Receives: Drug: Lanraplenib; Drug: Filgotinib placebo
Placebo to Filgotinib 200 mg	Experimental	After Week 12 Visit, participants on placebo will be rerandomized 1:1 and receive filgotinib + lanraplenib placebo in a blinded fashion through Week 48. Receives: Drug: Filgotinib; Drug: Lanraplenib placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) Activity Score From Baseline to 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.
Measured: Baseline; Week 12

Secondary outcomes (4)

Percentage of Participants at Week 12 With Decrease of ≥ 5 Points in CLASI Activity Score From Baseline
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.
Measured: Baseline; Week 12
Percentage of Participants at Week 12 With No Worsening in CLASI Activity Score From Baseline
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.
Measured: Baseline; Week 12
Percentage of Participants at Week 24 With Decrease of ≥ 5 Points in CLASI Activity Score From Baseline
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.
Measured: Baseline; Week 24
Percentage of Participants at Week 24 With No Worsening in CLASI Activity Score From Baseline
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.
Measured: Baseline; Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

24 May 201718 Dec 2019

First posted28 Apr 2017
Study start24 May 2017
Primary completion13 Mar 2019
Study completion18 Dec 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Cutaneous Lupus ErythematosusStudies of the same condition, open and under way.
More trials run by Gilead SciencesThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 47 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03134222
Sponsor's protocol ID: GS-US-436-4092
Status last verified: Jun 2020
First submitted: 25 Apr 2017
Last updated: 9 Jun 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 34498056

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 2
This Study Will Evaluate the Effect and Safety of 626 in Patients With CLE
Cutaneous Lupus Erythematosus (CLE)
RecruitingPhase 3
A Study of Enpatoran in Participants With Cutaneous Manifestations of Lupus With or Without Systemic Disease
Systemic Lupus Erythematosus (SLE), Cutaneous Lupus Erythematosus (CLE)
RecruitingPhase 3
A Study of Enpatoran in Participants With Cutaneous Manifestations of Lupus With or Without Systemic Disease (ELOWEN-2)
Systematic Lupus Erythematosus, Cutaneous Lupus Erythematosus
Active, not recruitingPhase 2
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 2a Study With an Open-Label Extension Evaluating the Efficacy and Safety of VENT-03 in Adult Participants With Active Cutaneous Lupus Erythematosus With or Without Systemic Lupus Erythematosus
Cutaneous Lupus Erythematosus (CLE), Systemic Lupus Erythematosus
RecruitingPhase 2/3
Study of Afimetoran in Adults With Cutaneous Lupus Erythematosus
Cutaneous Lupus Erythematosus (CLE), Systematic Lupus Erythematosus

All Cutaneous Lupus Erythematosus trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

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)
ClinicalTrials.gov ID: NCT03134222
Acronym / sponsor ID: GS-US-436-4092
Conditions: Cutaneous Lupus Erythematosus
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 47 participants (actual)
Lead sponsor: Gilead SciencesIndustry (pharma, biotech, devices)
Collaborators: Lakefront Biotherapeutics NV
Study start: 24 May 2017 (actual)
Primary completion: 13 Mar 2019 (actual)
Study completion: 18 Dec 2019 (actual)
First posted: 28 Apr 2017 (actual)
Results: Posted 8 Apr 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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).

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 5

Arm	Type	Receives
Lanraplenib 30 mg	Experimental	Drug: Lanraplenib, Drug: Filgotinib placeboLanraplenib + filgotinib placebo for 48 weeks
Filgotinib 200 mg	Experimental	Drug: Filgotinib, Drug: Lanraplenib placeboFilgotinib + lanraplenib placebo for 48 weeks
Placebo	Placebo comparator	Drug: Lanraplenib placebo, Drug: Filgotinib placeboFilgotinib placebo + lanraplenib placebo for 12 weeks
Placebo to Lanraplenib 30 mg	Experimental	Drug: Lanraplenib, Drug: Filgotinib placeboAfter Week 12 Visit, participants on placebo will be rerandomized 1:1 and receive lanraplenib + filgotinib placebo in a blinded fashion through Week 48.
Placebo to Filgotinib 200 mg	Experimental	Drug: Filgotinib, Drug: Lanraplenib placeboAfter Week 12 Visit, participants on placebo will be rerandomized 1:1 and receive filgotinib + lanraplenib placebo in a blinded fashion through Week 48.

Who may qualify

Ages: 18 to 75 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Must have a diagnosis of CLE, either chronic (e.g., discoid) or subacute CLE per investigator evaluation, with the following:
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 (2 listed)

Use of prohibited concomitant medications per study protocol
Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
LanraplenibAlso: GS-987630 mg tablets administered orally once daily with or without food	Drug	Lanraplenib 30 mg, Placebo to Lanraplenib 30 mg
FilgotinibAlso: GS-6034200 mg tablets administered orally once daily with or without food	Drug	Filgotinib 200 mg, Placebo to Filgotinib 200 mg
Lanraplenib placeboTablets administered orally once daily with or without food	Drug	Filgotinib 200 mg, Placebo, Placebo to Filgotinib 200 mg
Filgotinib placeboTablets administered orally once daily with or without food	Drug	Lanraplenib 30 mg, Placebo, Placebo to Lanraplenib 30 mg

Primary outcome

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.

4 secondary outcomes

Percentage of Participants at Week 12 With Decrease of ≥ 5 Points in CLASI Activity Score From Baseline
Time frame: Baseline; Week 12
Percentage of Participants at Week 12 With No Worsening in CLASI Activity Score From Baseline
Time frame: Baseline; Week 12
Percentage of Participants at Week 24 With Decrease of ≥ 5 Points in CLASI Activity Score From Baseline
Time frame: Baseline; Week 24
Percentage of Participants at Week 24 With No Worsening in CLASI Activity Score From Baseline
Time frame: Baseline; Week 24

Results and safety

Results posted to the registry on 8 Apr 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Lanraplenib 30 mg	19	14
Filgotinib 200 mg	18	14
Placebo	10	8
Placebo to Lanraplenib 30 mg	0	0
Placebo to Filgotinib 200 mg	0	0

Primary outcome: Change in Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) Activity Score From Baseline to Week 12

Time frame: Baseline; Week 12. Least squares mean (Standard Error). Unit: score on a scale

Measure	Lanraplenib 30 mg n = 16	Filgotinib 200 mg n = 16	Placebo n = 8
Value	-4.5 (1.91)	-8.7 (1.85)	-5.5 (2.56)

Lanraplenib 30 mg vs Placebo: p = 0.7500, Mixed-effect repeated measures model
Filgotinib 200 mg vs Placebo: p = 0.3047, Mixed-effect repeated measures model

Population analysed: 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.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: First dose date up to Week 48 plus 30 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Lanraplenib 30 mg	2 of 19 (10.5%)	17 of 19 (89.5%)	0 of 19
Filgotinib 200 mg	1 of 17 (5.9%)	11 of 17 (64.7%)	0 of 17
Placebo	0 of 9 (0%)	6 of 9 (66.7%)	0 of 9
Placebo to Lanraplenib 30 mg	0 of 4 (0%)	3 of 4 (75%)	0 of 4
Placebo to Filgotinib 200 mg	0 of 4 (0%)	3 of 4 (75%)	0 of 4

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 34498056Werth 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.
Individual participant dataSharing planned: No

Related trials for Cutaneous Lupus Erythematosus

Not yet recruitingPhase 2
This Study Will Evaluate the Effect and Safety of 626 in Patients With CLE
Cutaneous Lupus Erythematosus (CLE)
RecruitingPhase 3
A Study of Enpatoran in Participants With Cutaneous Manifestations of Lupus With or Without Systemic Disease
Systemic Lupus Erythematosus (SLE), Cutaneous Lupus Erythematosus (CLE)
RecruitingPhase 3
A Study of Enpatoran in Participants With Cutaneous Manifestations of Lupus With or Without Systemic Disease (ELOWEN-2)
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Active, not recruitingPhase 2
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 2a Study With an Open-Label Extension Evaluating the Efficacy and Safety of VENT-03 in Adult Participants With Active Cutaneous Lupus Erythematosus With or Without Systemic Lupus Erythematosus
Cutaneous Lupus Erythematosus (CLE), Systemic Lupus Erythematosus
RecruitingPhase 2/3
Study of Afimetoran in Adults With Cutaneous Lupus Erythematosus
Cutaneous Lupus Erythematosus (CLE), Systematic Lupus Erythematosus

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Gilead Study Director study director

Gilead Sciences

16 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Lanraplenib and Filgotinib in people with Cutaneous Lupus Erythematosus, run by Gilead Sciences at 16 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Apr 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) Activity Score From Baseline to Week 12 (time frame: Baseline; Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03134222, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2020.