Subacute Cutaneous Lupus ErythematosusPhase 2NCT06980805
A Study to Assess the Safety, Tolerability, and Efficacy of IMVT-1402 in Participants With Cutaneous Lupus Erythematosus (CLE)
A Phase 2 study testing IMVT-1402 in people with Subacute Cutaneous Lupus Erythematosus and Chronic Cutaneous Lupus Erythematosus, run by Immunovant Sciences GmbH at 86 sites in 13 countries.
Trial summary
The primary purpose of this study is to evaluate the efficacy, safety, and tolerability of IMVT-1402 in participants with Cutaneous Lupus Erythematosus. The study will consist of 3 periods: Period 1: eligible participants will be randomized 1:1 to IMVT-1402 Dose 1 or placebo SC QW for 12 weeks. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Subacute Cutaneous Lupus Erythematosus, Chronic Cutaneous Lupus Erythematosus
- What is being tested?
- IMVT-1402
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 86 sitesin 13 countries
- Study dates
- 19 Feb 2025to Apr 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have documented diagnosis of SCLE or CCLE that has been confirmed by biopsy with or without systemic LE manifestations.
- Have a total CLASI-A score of ≥10 at Screening and Day 1. Participants with a CLASI-A score of ≥8 and <10 are eligible if the score does not include alopecia and/or mucous membrane lesions.
- Have active CLE despite an adequate trial of conventional therapies.
- Are positive for at least one autoantibody at Screening.
Who cannot join
- Have known or suspected drug-induced CLE anti-phospholipid disease, or neuropsychiatric SLE.
- Have rapidly progressive nephritis.
- Have current inflammatory skin disease other than SCLE/CCLE that, in the opinion of the Investigator, could interfere with the inflammatory skin assessments or confound the disease activity assessments.
- Note: Other protocol defined Inclusion/Exclusion criteria may apply
Trial locations and contacts
86 sites in 13 countries.
86 sites in 13 countries
United States33 sites
Site Number - 1010
Anniston, Alabama, 36207-4780
Site Number - 1019
Auburn Hills, Michigan, 48326-3396
Site Number - 1000
Aurora, Colorado, 80045-2541
Site Number - 1022
Beverly Hills, California, 90211
Site Number - 1020
Birmingham, Alabama, 35203-4050
Site Number - 1030
Brighton, Massachusetts, 02135
Site Number - 1009
Buford, Georgia, 30518-8721
Site Number - 1033
Castle Rock, Colorado, 80109-8034
Site Number - 1007
Charlotte, North Carolina, 28211-1064
Site Number - 1018
Chula Vista, California, 91910
Site Number - 1039
Corona, California, 92882
Site Number - 1008
Durham, North Carolina, 27713-8505
Site Number - 1021
Farmington, Connecticut, 06030-2840
Site Number - 1005
Fremont, California, 94538
Site Number - 1002
Hershey, Pennsylvania, 17033
Site Number - 1014
Hialeah, Florida, 33012
Site Number - 1035
Houston, Texas, 77030
Site Number - 1012
Irving, Texas, 75061
Site Number - 1017
Jacksonville, Florida, 32256
Site Number - 1023
Los Angeles, California, 90045
Site Number - 1028
Miami, Florida, 33122
Site Number - 1024
Miami, Florida, 33133
Site Number - 1027
Miami, Florida, 33136
Site Number - 1011
Miami Lakes, Florida, 33014-5602
Site Number - 1025
Orlando, Florida, 32819
Site Number - 1015
Philadelphia, Pennsylvania, 19103-4708
Site Number - 1038
Phoenix, Arizona, 85037
Site Number - 1003
Saint Clair Shores, Michigan, 48081-1274
Site Number - 1004
Saint Joseph, Missouri, 64506-2459
Site Number - 1034
Scottsdale, Arizona, 85260
Site Number - 1006
Smithfield, North Carolina, 27577-4664
Site Number - 1026
St Louis, Missouri, 63104
Site Number - 1013
Troy, Michigan, 48084 3536
Greece7 sites
Site Number - 3901
Athens, Attica, 16121
Site Number - 3902
Attiki, Athens, 104 31
Site Number - 3900
Attiki, 12462
Site Number - 3906
Heraklion, Crete, 71110
Site Number - 3904
Larissa, 411 10
Site Number - 3903
Thessaloniki, Central Macedonia, 56403
Site Number - 3905
Thessaloniki, Central Macedonia, 56403
Poland7 sites
Site Number - 3005
Gorzów Wielkopolski, Lubusz Voivodeship, 66-400
Site Number - 3003
Lodz, 90-436
Site Number - 3004
Poznan, Greater Poland Voivodeship, 60-702
Site Number - 3006
Rzeszów, Pakistan, 35-055
Site Number - 3002
Rzeszów, Podkarpackie Voivodeship, 35-309
Site Number - 3000
Warsaw, Masovian Voivodeship, 00-716
Site Number - 3001
Warsaw, Masovian Voivodeship, 00-874
Spain6 sites
Site Number - 7104
Badalona, Catalonia, 8916
Site Number - 7101
Burjassot, Valencia, 46100
Site Number - 7100
Madrid, 28003
Site Number - 7102
Madrid, 28041
Site Number - 7103
Málaga, 29016
Site Number - 7105
Pamplona, Navarre, 31008
Argentina5 sites
Site Number -5004
CABA, 1406
Site Number - 5000
CABA, C1023AAB
Site Number - 5001
CABA, C1425DND
Site Number - 5002
San Miguel de Tucumán, T4000AXL
Site Number - 5003
San Miguel de Tucumán, T4000IHE
Bulgaria5 sites
Site Number - 5601
Sofia, 1257
Site Number - 5603
Sofia, 1431
Site Number - 5600
Sofia, 1606
Site Number - 5605
Sofia, 1618
Site Number - 5606
Sofia, 1680
Chile5 sites
Site Number - 5702
Independencia, 8380000
Site Number - 5704
Santiago, 7640881
Site Number - 5703
Santiago, 8320000
Site Number - 5701
Temuco, 4810345
Site Number - 5700
Victoria, 4720638
Germany4 sites
Site Number - 6503
Bochum, North Rhine-Westphalia, 44791
Site Number - 6500
Erlangen, Bavaria, 91054
Site Number - 6501
Oldenburg, Lower Saxony, 26133
Site Number - 6502
Tübingen, Baden-Wurttemberg, 72076
Canada3 sites
Site Number - 2000
Calgary, Alberta, T2W 4X9
Site Number - 2003
Sarnia, Ontario, N7T 5W4
Site Number - 2002
Vancouver, British Columbia, V5Z 4E8
Puerto Rico3 sites
Site Number-1029
Caguas, 00725-2443
Site Number - 1037
Ponce, 00716-0377
Site Number - 1036
San Juan, 918
Serbia3 sites
Site Number - 9000
Belgrade, 11000
Site Number - 9001
Belgrade, 11000
Site Number - 9003
Novi Sad, 21000
United Kingdom3 sites
Site Number - 7002
Leeds, West Yorkshire, LS7 4SA
Site Number - 7003
London, SE1 9RT
Site Number - 7000
Manchester, M15 6SE
Georgia2 sites
Site Number - 8002
Tbilisi, 0112
Site Number - 8000
Tbilisi, 0160
About this study
Official title: A Phase 2b, Randomized, Double-blind, Placebo-controlled Study to Assess the Safety, Tolerability, and Efficacy of IMVT-1402 in Participants With Active Subacute Cutaneous Lupus Erythematosus (SCLE) and/or Chronic Cutaneous Lupus Erythematosus (CCLE) With or Without Systemic Manifestations
The primary purpose of this study is to evaluate the efficacy, safety, and tolerability of IMVT-1402 in participants with Cutaneous Lupus Erythematosus.
The study will consist of 3 periods:
Period 1: eligible participants will be randomized 1:1 to IMVT-1402 Dose 1 or placebo SC QW for 12 weeks.
Period 2: participants who completed Period 1 will receive IMVT-1402 Dose 1 SC QW for 14 weeks.
Period 3: after completion of Period 2, participants will be re-randomized 1:1 to blinded IMVT-1402 Dose 1 or Dose 2 SC QW for 26 weeks.
Read the detailed description
The total study duration per participant is approximately 61 weeks.
- Being tested
- IMVT-1402, Placebo
- Keywords
- Chronic Cutaneous Lupus Erythematosus, Subacute Cutaneous Lupus Erythematosus, IMVT-1402, Imeroprubart
- Medical subject headings
- Lupus Erythematosus, Cutaneous, Lupus Erythematosus, Discoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMVT-1402Drug
Dose 1 or Dose 2 SC QW
PlaceboDrug
Matching Placebo SC QW
| Study group | Role | What they receive |
|---|---|---|
| Period 1: Placebo | Placebo comparator | Matching placebo for 12 weeks in Period 1 Receives: Drug: Placebo |
| IMVT-1402 Subcutaneous (SC) Once weekly (QW) | Experimental | * Period 1: IMVT-1402 Dose 1 SC QW for 12 weeks
* Period 2: IMVT-1402 Dose 1 SC QW for 14 weeks
* Period 3: IMVT-1402 Dose 1 or Dose 2 SC QW for 26 weeks Receives: Drug: IMVT-1402 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent change from Period 1 Baseline in Cutaneous Lupus Erythematosus Disease area and Severity Index activity (CLASI-A) score at Week 12
The CLASI-A score represents the overall severity of cutaneous lupus erythematosus (CLE) dermatologic involvement. It is used to assess the activity of mucocutaneous lesions in patients with lupus. The score ranges from 0 (no active lesions) to a maximum of 70. Values between 1 and 9 indicate mild inflammation, 10 to 20 indicate moderate inflammation, and 21 or higher indicate severe inflammation.
Measured: Baseline (Day 1) and Week 12
Secondary outcomes (3)
Proportion of participants who have a reduction in CLASI-A score of ≥ 5 points from Period 1 Baseline at Week 12
Measured: Baseline (Day 1) and Week 12
Proportion of participants who have a reduction in CLASI-A score of ≥ 50% from Period 1 Baseline at Week 12
Measured: Baseline (Day 1) and Week 12
Proportion of participants who have a reduction in CLASI-A score of ≥ 70% from Period 1 Baseline at Week 12
Measured: Baseline (Day 1) and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2025
- Study start19 Feb 2025
- Primary completionOct 2026 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subacute Cutaneous Lupus ErythematosusStudies of the same condition, open and under way.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Immunovant Sciences GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06980805
- Sponsor's protocol ID
- IMVT-1402-2701
- Other IDs
- 2024-516745-39-00
- Status last verified
- Aug 2026
- First submitted
- 8 May 2025
- Last updated
- 28 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2b, Randomized, Double-blind, Placebo-controlled Study to Assess the Safety, Tolerability, and Efficacy of IMVT-1402 in Participants With Active Subacute Cutaneous Lupus Erythematosus (SCLE) and/or Chronic Cutaneous Lupus Erythematosus (CCLE) With or Without Systemic Manifestations
- ClinicalTrials.gov ID
- NCT06980805
- Acronym / sponsor ID
- IMVT-1402-2701
- Keywords
- Chronic Cutaneous Lupus Erythematosus, Subacute Cutaneous Lupus Erythematosus, IMVT-1402, Imeroprubart
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Immunovant Sciences GmbHIndustry (pharma, biotech, devices)
- Study start
- 19 Feb 2025 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 20 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary purpose of this study is to evaluate the efficacy, safety, and tolerability of IMVT-1402 in participants with Cutaneous Lupus Erythematosus.
The study will consist of 3 periods:
Period 1: eligible participants will be randomized 1:1 to IMVT-1402 Dose 1 or placebo SC QW for 12 weeks.
Period 2: participants who completed Period 1 will receive IMVT-1402 Dose 1 SC QW for 14 weeks.
Period 3: after completion of Period 2, participants will be re-randomized 1:1 to blinded IMVT-1402 Dose 1 or Dose 2 SC QW for 26 weeks.
Detailed description
The total study duration per participant is approximately 61 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Period 1: Placebo | Placebo comparator | Drug: PlaceboMatching placebo for 12 weeks in Period 1 |
| IMVT-1402 Subcutaneous (SC) Once weekly (QW) | Experimental | Drug: IMVT-1402* Period 1: IMVT-1402 Dose 1 SC QW for 12 weeks * Period 2: IMVT-1402 Dose 1 SC QW for 14 weeks * Period 3: IMVT-1402 Dose 1 or Dose 2 SC QW for 26 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Have documented diagnosis of SCLE or CCLE that has been confirmed by biopsy with or without systemic LE manifestations.
- Have a total CLASI-A score of ≥10 at Screening and Day 1. Participants with a CLASI-A score of ≥8 and <10 are eligible if the score does not include alopecia and/or mucous membrane lesions.
- Have active CLE despite an adequate trial of conventional therapies.
- Are positive for at least one autoantibody at Screening.
Key exclusion criteria (4 listed)
- Have known or suspected drug-induced CLE anti-phospholipid disease, or neuropsychiatric SLE.
- Have rapidly progressive nephritis.
- Have current inflammatory skin disease other than SCLE/CCLE that, in the opinion of the Investigator, could interfere with the inflammatory skin assessments or confound the disease activity assessments.
- 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 |
|---|---|---|
| IMVT-1402Dose 1 or Dose 2 SC QW | Drug | IMVT-1402 Subcutaneous (SC) Once weekly (QW) |
| PlaceboMatching Placebo SC QW | Drug | Period 1: Placebo |
Primary outcome
Percent change from Period 1 Baseline in Cutaneous Lupus Erythematosus Disease area and Severity Index activity (CLASI-A) score at Week 12
Time frame: Baseline (Day 1) and Week 12
The CLASI-A score represents the overall severity of cutaneous lupus erythematosus (CLE) dermatologic involvement. It is used to assess the activity of mucocutaneous lesions in patients with lupus. The score ranges from 0 (no active lesions) to a maximum of 70. Values between 1 and 9 indicate mild inflammation, 10 to 20 indicate moderate inflammation, and 21 or higher indicate severe inflammation.
3 secondary outcomes
Proportion of participants who have a reduction in CLASI-A score of ≥ 5 points from Period 1 Baseline at Week 12
Time frame: Baseline (Day 1) and Week 12
Proportion of participants who have a reduction in CLASI-A score of ≥ 50% from Period 1 Baseline at Week 12
Time frame: Baseline (Day 1) and Week 12
Proportion of participants who have a reduction in CLASI-A score of ≥ 70% from Period 1 Baseline at Week 12
Time frame: Baseline (Day 1) and Week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for Subacute Cutaneous Lupus Erythematosus
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
RecruitingPhase 2/3
Study of Afimetoran in Adults With Cutaneous Lupus Erythematosus
Cutaneous Lupus Erythematosus (CLE), Systematic Lupus Erythematosus
Active, not recruitingPhase 2/3
A 2-Part Study to Learn Whether Litifilimab (BIIB059) Injections Can Improve Symptoms of Adult Participants Who Have Active Cutaneous Lupus Erythematosus
Subacute Cutaneous Lupus Erythematosus, Chronic Cutaneous Lupus Erythematosus
Active, not recruitingPhase 2
The Willow LTE Study With M5049 in Participants With SCLE, DLE and/or SLE (WILLOW LTE)
Systemic 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.
The record lists no contact. Use the official record to reach the sponsor.
86 sites in 13 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing IMVT-1402 in people with Subacute Cutaneous Lupus Erythematosus and Chronic Cutaneous Lupus Erythematosus, run by Immunovant Sciences GmbH at 86 sites in 13 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 4 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: under way, not looking for participants, as of the sponsor's last update on 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 86 sites in United States, Greece, Poland, Spain, Argentina and 8 more countries. 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?
This study is still under way. Results are not available in the source record yet.
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?
Percent change from Period 1 Baseline in Cutaneous Lupus Erythematosus Disease area and Severity Index activity (CLASI-A) score at Week 12 (time frame: Baseline (Day 1) and Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Aug 2026.