The Willow LTE Study With M5049 in Participants With SCLE, DLE and/or SLE (WILLOW LTE)

Merck KGaA (EMD Serono)

Status and phase: Enrolling; Phase 2

Conditions: Systemic Lupus Erythematosus

Treatments: Drug: M5049 medium dose; Drug: M5049 low dose; Drug: Placebo; Drug: M5049 very high dose; Drug: M5049 high dose

Study type: Interventional

Funder types: Industry

Identifiers

NCT05540327

2022-000239-21 (EudraCT Number)

MS200569_0048

Details and patient eligibility

About

The purpose of the study is to evaluate the long term safety and efficacy of orally administered M5049 in participants with subacute cutaneous lupus erythematosus (SCLE), discoid lupus erythematosus (DLE) and/or systemic lupus erythematosus (SLE) who have completed the 24 week treatment period of Willow study (MS200569_0003 [NCT05162586]).

Enrollment: 532 estimated patients

Sex: All

Ages: 18 to 76 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Are active SCLE, DLE and/or SLE that have completed the 24 week Treatment of the Willow Study
• Have a Body Mass Index (BMI) within the >= 40 kilograms per meter square (inclusive) at Screening
• Other protocol defined inclusion criteria could apply

Exclusion criteria

• Participants who experienced serious event(s) related to the study intervention during the WILLOW study
• Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with Long Term Extension (LTE) study participation
• Ongoing or active clinically significant viral (including Severe acute respiratory syndrome coronavirus 2 [(SARS-CoV-2)], bacterial or fungal infection, or any major episode of infection requiring hospitalization
• Received LTE prohibited medication during the WILLOW study or after the WILLOW study Week 24
• Participation in any other investigational drug study after the WILLOW study Week 24
• Other protocol defined exclusion criteria could apply

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

532 participants in 4 patient groups

M5049 low dose + Placebo

Experimental group

Description:

Participants with CLE (active SCLE and/or DLE) or SLE who received low dose of M5049 in WILLOW study will continue to receive M5049 low dose and matching placebo.

Treatment:

Drug: Placebo

Drug: M5049 low dose

M5049 medium dose+ Placebo

Experimental group

Description:

Participants with CLE (active SCLE and/or DLE) or SLE who received medium dose of M5049 in WILLOW study will continue to receive M5049 medium dose and matching placebo.

Treatment:

Drug: Placebo

Drug: M5049 medium dose

M5049 high dose + Placebo

Experimental group

Description:

Participants with CLE (active SCLE and/or DLE) or SLE who received M5049 matched placebo or high dose of M5049 in WILLOW study will receive M5049 high dose .

Treatment:

Drug: M5049 high dose

Drug: Placebo

M5049 very high dose + Placebo

Experimental group

Description:

Participants with CLE (active SCLE and/or DLE) or SLE who received M5049 matched placebo or very high dose of M5049 in WILLOW study will receive M5049 very high dose.

Treatment:

Drug: M5049 very high dose

Drug: Placebo