The WILLOW LTE study with enpatoran in participants with SCLE, DLE and/or SLE

Phase 1

• Conditions: Systemic lupus erythematosus (SLE) and cutaneous lupus erythematosus (CLE); MedDRA version: 21.1Level: PTClassification code 10056509Term: Cutaneous lupus erythematosusSystem Organ Class: 10040785 - Skin and subcutaneous tissue disorders; MedDRA version: 21.1Level: PTClassification code 10042945Term: Systemic lupus erythematosusSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; MedDRA version: 21.1Level: PTClassification code 10057903Term: Subacute cutaneous lupus erythematosusSystem Organ Class: 10040785 - Skin and subcutaneous tissue disorders; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2022-000239-21-BG
• Lead Sponsor: Merck Healthcare KGaA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-07-27
• Last Update Posted: 27 November 2023

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 532

Inclusion Criteria

1. Are = 18 and = 76 years of age at the time of signing the informed consent.
2. Are SCLE, DLE and/or SLE participants that have completed the 24-week Treatment of the WILLOW study.
3. Have a BMI within the range = 40 kg/m2.
4. Male or Female
The investigator confirms that each participant agrees to use appropriate contraception and barriers, if applicable. The contraception, barrier, and pregnancy testing requirements are below. Contraceptive use will be consistent with local regulations on contraception methods for those participating in clinical studies.
a) Female participant:
• Is not breastfeeding
• Is not pregnant (i.e., has a negative highly sensitive urine pregnancy test, as required by local regulations, within 24 hours before the first dose of study intervention). If a urine test cannot be confirmed as negative (e.g., an ambiguous result), a serum pregnancy test is required.
•Is not a woman of childbearing potential (WOCBP)
• If a WOCBP, use a highly effective contraceptive method (i.e., with a failure rate of < 1% per year), preferably with low user dependency (2 methods may be considered to achieve optimal results i.e., < 1% failure rate per year), as described in Appendix 3 Contraception and Barrier Requirements for the following time periods:
b) Male Participants:
• Refrain from donating fresh unwashed semen.
PLUS, either:
• Abstain from any activity that allows for exposure to ejaculate.
OR
• Use a male condom:
Agree to the following during the study until at least 90 days (a spermatogenesis cycle) after the last dose of study intervention.

Please refer to the Protocol for additional details about this criteria.

5. Are up to date, according to local guidelines, with vaccination against Streptococcus pneumoniae and influenza virus (as seasonally required for influenza virus).
6. Capable of giving signed informed consent, as indicated in Appendix 2, which includes compliance with the requirements and restrictions listed in the ICF and this protocol.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 430
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

1. Participants who experienced serious event(s) related to the study intervention during the WILLOW study, an unstable medical condition, or any other reason, in the opinion of the Investigator or Sponsor/designee that would preclude participation in this LTE study.
2. Other severe acute or chronic medical or psychiatric condition. Clinically significant ECG findings or laboratory abnormality that may increase the risk associated with LTE study participation or study intervention administration and, in the judgement of the Investigator or Sponsor/designee opinion, would make the participant inappropriate to participate in this LTE study.
3. Active clinically significant viral (including SARS-CoV-2), bacterial or fungal infection, or any major episode of infection requiring hospitalization or treatment with parenteral anti-infectives. Vaginal candidiasis, onychomycosis, and genital or oral herpes simplex virus considered sufficiently controlled will not be exclusionary.
4. Note: if sign/symptoms suggest any underlying infection (at Investigator discretion), a negative or normal test result must be provided and discussed with the Medical Monitor.
• All participants who entered the WILLOW study with positive anti HBc antibody and/or anti-HBs antibody with non-detectable HBV DNA at Screening must provide a negative HBV DNA PCR result.
5. Received LTE prohibited medication during the WILLOW study or after the WILLOW study Week 24/EOT Visit (may require prior discussion with Medical Monitor).
6. Participation in any other investigational drug study after the WILLOW study Week 24/EOT Visit.
7. Withdrawn during the WILLOW study due to any of the pre-defined criteria for study intervention or study withdrawal.
8. Planned major elective medical or surgical procedure.
9. Breastfeeding/lactating or pregnant women. Lactating women are excluded regardless of whether or not they are nursing infant(s).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified