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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Merck Healthcare KGaA

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Immune System Diseases [C20], Diseases [C] - Skin and Connective Tissue Diseases [C17]

Trial duration

21 Nov 2022 → ongoing

Decision date (initial)

2024-07-17

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Merck Healthcare KGaA

External identifiers

EU CT number

2024-510871-39-00

EudraCT number

2022-000239-21

ClinicalTrials.gov

NCT05540327

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Therapy, Efficacy, Pharmacokinetic

Part 1 and Part 2: To evaluate the long-term safety and tolerability of enpatoran in participants with SCLE, DLE, and/or SLE

Secondary objectives 1

1. Part 1 and Part 2: To evaluate the long-term safety and tolerability of enpatoran in participants with SCLE, DLE, and/or SLE

Conditions and MedDRA coding

Systemic lupus erythematosus (SLE) and cutaneous lupus erythematosus (CLE)

Regulatory references

Plan to share IPD

Yes

IPD plan description

We are committed to enhancing public health through responsible sharing of clinical trial data. Following approval of a new product or a new indication for an approved product in both the US and European Union, the study sponsor and/or its affiliated companies will share study protocols, anonymized patient data and study level data, and redacted clinical study reports with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website bit.ly/IPD21

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. Are ≥ 18 and ≤ 76 years of age at the time of signing the informed consent
2. Are active SCLE, DLE and/or SLE that have completed the 24 week Treatment of the Willow Study
3. Have a Body Mass Index (BMI) within the greater than or equal to (>=) 40 kilograms per meter square (inclusive) at Screening
4. Participants who had successfully completed Week 48 of the Part 1 will have the opportunity to participate in the LTE Part 2. In exceptional cases and after Sponsor review, participants who have completed the Week 48 visit of the Part 1 within the previous 4-weeks may be considered for Part 2 participation based on eligibility review. Previous 4-weeks will be calculated from the Week 48 visit of Part 1
5. Other protocol defined inclusion criteria could apply

Exclusion criteria 5

1. 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
2. Ongoing or active clinically significant viral (including Severe acute arespiratory syndrome coronavirus 2 [(SARS‑CoV‑2)], bacterial or fungal infection, or any major episode of infection requiring hospitalization
3. Received LTE prohibited medication during the WILLOW study or after the WILLOW study Week 24
4. Participation in any other investigational drug study after the WILLOW study Week 24
5. Other protocol defined exclusion criteria could apply

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. Part 1: Safety Profile as Assessed by Incidence of Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Adverse Event of Special Interest (AESIs)
2. Part 2: Safety Profile as Assessed by Incidence of Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Adverse Event of Special Interest (AESIs)

Secondary endpoints 1

1. Part 1 and Part 2: Number of Participants with Abnormalities in Laboratory Parameters and QT Interval Corrected

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Merck Healthcare KGaA

Sponsor organisation

Merck Healthcare KGaA

Address

Frankfurter Strasse 250

City

Darmstadt

Postcode

64293

Country

Germany

Scientific contact point

Organisation

Merck Healthcare KGaA

Contact name

Global Regulatory Affairs

Public contact point

Organisation

Merck Healthcare KGaA

Contact name

Global Regulatory Affairs

Third parties 8

Locations

5 EU/EEA countries · 13 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 151 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

3 submissions — initial application plus substantial / non-substantial modifications