Study IMVT-1402-2701 is a Phase 2b, multi-center, randomized, double-blind, placebo-controlled study to assess the efficacy, safety, and tolerability of IMVT-1402 in participants with autoantibody positive active CLE (SCLE or CCLE) with or without systemic manifestations. On Day 1, eligible participants will be randomized in a 1:1 ratio to blinded IMVT-1402 600 mg SC QW or placebo SC QW for 12 weeks. IMVT-1402 or placebo will be administered as add-on therapy to the permitted ongoing standard of care for CLE in accordance with the protocol.

Who can Participate

Key Inclusion Criteria: Disease-specific 1. Must have documented diagnosis of SCLE or CCLE that has been confirmed by biopsy (in the past or at Screening), with or without systemic LE manifestations. Diagnosis for CLE will be confirmed by a central adjudication committee. For participants without a historical biopsy or who are unable to provide evidence of historical biopsy results confirming diagnosis of CLE, a skin biopsy must be performed during the Screening Period to confirm CLE diagnosis before randomization. Note: if a skin biopsy is required to assess eligibility, it is recommended that it be performed after most or all other eligibility criteria have been assessed in order to reduce the risk of exposing the participant to an un-necessary biopsy if eligibility is not met based on other criteria. Considerations should be given to the turn-around time of the pathology and adjudication results to remain within the 5-week screening window. 2. 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. 3. Must have active CLE despite an adequate trial of conventional therapies (defined as either corticosteroids or an antimalarial agent used for at least 12-weeks prior to Screening) OR previously documented failure to respond to these agents when used for at least 12-weeks OR the requirement to discontinue these agents due to side effects or poor tolerability. 4. Are positive for at least one of the following as assessed at Screening: a. anti-nuclear antibody (ANA) b. elevated anti-double-stranded DNA c. anti-Ro/SSA d. anti-La/SSB e. anti-Sm f. anti-RNP70 g. positive direct immunofluorescence confirming IgG deposition in a skin biopsy Key Exclusion Criteria: Disease-specific 5. Have known or suspected drug-induced CLE antiphospholipid disease, or neuropsychiatric SLE. 6. Have rapidly progressive nephritis as defined by any of the following: a. Serum creatinine greater than 1.7 mg/dL b. Urine protein/creatinine ratio >0.3 mg/mg c. Suspected or biopsy-proven proliferative (class III or IV) or membranous (class V) lupus nephritis in participants receiving induction therapy (e.g., mycophenolate, cyclophosphamide, calcineurin inhibitor) that was initiated within 6 months of the Screening Visit Note: as per exclusion criterion 17h, if the participant has been treated with cyclophosphamide or a calcineurin inhibitor within 3 months of the Screening Visit, the participant must be excluded from the study. 7. 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. 8. Use of immunosuppressive or disease-modifying treatments that were initiated less than 3-months prior to Screening, have not been at a stable dose for at least 1-month prior to Screening or have been taken at doses above the prescribed maximum listed below: a. Prednisone: 20 mg/day (or dose equivalent) b. Antimalarials: c. Hydroxychloroquine 400 mg/day d. Quinacrine 100 mg/day e. Chloroquine 250 mg/day c. Conventional synthetic Disease-modifying antirheumatic drugs (DMARDs): i. Azathioprine 200 mg/day ii. Dapsone 150 mg/day iii. Methotrexate 25 mg/week iv. 6-mercaptopurine 1.5 mg/kg/day v. Mycophenolate mofetil 3 g/day vi. Mycophenolate sodium 2160 mg/day Note: Use of 2 or more immunosuppressive agents is permitted in total (from [a], [b], and/or [c]). Participants who complete Period 1 will enter Period 2 where all participants will receive IMVT- 1402 600 mg SC QW for 14 weeks. Participants who complete Period 2 will enter Period 3 at the Week 26 Visit where they will be re-randomized in a 1:1 ratio to receive blinded IMVT-1402 300 mg SC QW or 600 mg SC QW for 26 weeks. Key Inclusion Criteria: Disease-specific 1. Must have documented diagnosis of SCLE or CCLE that has been confirmed by biopsy (in the past or at Screening), with or without systemic LE manifestations. Diagnosis for CLE will be confirmed by a central adjudication committee. For participants without a historical biopsy or who are unable to provide evidence of historical biopsy results confirming diagnosis of CLE, a skin biopsy must be performed during the Screening Period to confirm CLE diagnosis before randomization. Note: if a skin biopsy is required to assess eligibility, it is recommended that it be performed after most or all other eligibility criteria have been assessed in order to reduce the risk of exposing the participant to an un-necessary biopsy if eligibility is not met based on other criteria. Considerations should be given to the turn-around time of the pathology and adjudication results to remain within the 5-week screening window. 2. 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. 3. Must have active CLE despite an adequate trial of conventional therapies (defined as either corticosteroids or an antimalarial agent used for at least 12-weeks prior to Screening) OR previously documented failure to respond to these agents when used for at least 12-weeks OR the requirement to discontinue these agents due to side effects or poor tolerability. 4. Are positive for at least one of the following as assessed at Screening: a. anti-nuclear antibody (ANA) b. elevated anti-double-stranded DNA c. anti-Ro/SSA d. anti-La/SSB e. anti-Sm f. anti-RNP70 g. positive direct immunofluorescence confirming IgG deposition in a skin biopsy Key Exclusion Criteria: Disease-specific 5. Have known or suspected drug-induced CLE antiphospholipid disease, or neuropsychiatric SLE. 6. Have rapidly progressive nephritis as defined by any of the following: a. Serum creatinine greater than 1.7 mg/dL b. Urine protein/creatinine ratio >0.3 mg/mg c. Suspected or biopsy-proven proliferative (class III or IV) or membranous (class V) lupus nephritis in participants receiving induction therapy (e.g., mycophenolate, cyclophosphamide, calcineurin inhibitor) that was initiated within 6 months of the Screening Visit Note: as per exclusion criterion 17h, if the participant has been treated with cyclophosphamide or a calcineurin inhibitor within 3 months of the Screening Visit, the participant must be excluded from the study. 7. 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. 8. Use of immunosuppressive or disease-modifying treatments that were initiated less than 3-months prior to Screening, have not been at a stable dose for at least 1-month prior to Screening or have been taken at doses above the prescribed maximum listed below: a. Prednisone: 20 mg/day (or dose equivalent) b. Antimalarials: c. Hydroxychloroquine 400 mg/day d. Quinacrine 100 mg/day e. Chloroquine 250 mg/day c. Conventional synthetic Disease-modifying antirheumatic drugs (DMARDs): i. Azathioprine 200 mg/day ii. Dapsone 150 mg/day iii. Methotrexate 25 mg/week iv. 6-mercaptopurine 1.5 mg/kg/day v. Mycophenolate mofetil 3 g/day vi. Mycophenolate sodium 2160 mg/day Note: Use of ≤ 2 immunosuppressive agents is permitted in total (from [a], [b], and/or [c]). 9. Have used any of the following prior medications or therapeutic procedures within the specified timeframe: a. Immunoglobulin treatment given by SC, IV, or IM route ≤ 8 weeks prior to or at the Screening Visit. b. PLEX or immunoadsorption treatment used ≤ 4 weeks prior to or at the Screening Visit. c. Rituxim

Study ID