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

Study Purpose

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]).

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 76 Years
Gender	All

More Inclusion & Exclusion Criteria

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 Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05540327
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Medical Responsible
Principal Investigator Affiliation	Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	Argentina, Australia, Bulgaria, Chile, China, Colombia, Greece, Japan, Korea, Republic of, Mauritius, Mexico, Moldova, Republic of, Philippines, Poland, Serbia, South Africa, Spain, United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Systemic Lupus Erythematosus
Study Website:	View Trial Website

Arms & Interventions

Arms

Experimental: M5049 low dose + Placebo

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.

Experimental: M5049 medium dose+ Placebo

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.

Experimental: M5049 high dose + Placebo

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 .

Experimental: M5049 very high dose + Placebo

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.

Interventions

Drug: - M5049 low dose

Participants will receive film-coated tablets of M5049 at a low dose orally, twice a day (BID) for up to 48 weeks.

Drug: - M5049 medium dose

Participants will receive film-coated tablets of M5049 at a medium dose orally, BID for up to 48 weeks.

Drug: - M5049 high dose

Participants will receive film-coated tablets of M5049 at a high dose orally, BID for up to 48 weeks.

Drug: - Placebo

Participants will receive M5049 matching placebo orally, BID for up to 48 weeks.

Drug: - M5049 very high dose

Participants will receive film-coated tablets of M5049 at a very high dose orally, BID for up to 48 weeks.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Advance Medical Research Center, Miami, Florida

Status

Recruiting

Address

Advance Medical Research Center

Miami, Florida, 33135

Site Contact

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