Long-term safety and tolerability of cenerimod in adults with systemic lupus erythematosus (OPUS OLE)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Viatris Innovation GmbH

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Immune System Diseases [C20]

Trial duration

1 Nov 2024 → ongoing

Decision date (initial)

2024-09-30

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

External identifiers

EU CT number

2024-514354-67-00

ClinicalTrials.gov

NCT06475742

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety

The primary objective of the study is to assess the long-term safety and tolerability of cenerimod 4 mg on top of background therapy in subjects with systemic lupus erythematosus (SLE).

Conditions and MedDRA coding

Systemic lupus erythematosus

Study design 2 periods

Regulatory references

Scientific advice from competent authorities

European Medicines Agency, European Medicines Agency, European Medicines Agency

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

1. Signed and dated informed consent form prior to any study-mandated procedure.
2. Male and female participants (aged 18-75 years) with a diagnosis of systemic lupus erythematosus who: • Completed the 12-month double-blind treatment period of either of the parent studies (ID-064A301, ID-064A302). • Did not meet any study treatment stopping criteria during the parent study. • Completed the last scheduled visit of the parent study. Participants who did not complete the last scheduled visit for reasons beyond their control maybe eligible for this study upon approval by the sponsor.
3. For women of child-bearing potential: • Negative pregnancy test at Visit 1. • Agreement to undertake monthly urine pregnancy tests from Visit 2 up to 6 months after study treatment discontinuation. • Agreement to use a highly effective method of contraception from Visit 1 up to 6 months after study treatment discontinuation.

Exclusion criteria 5

1. Poor compliance with study-mandated procedures during the parent study (ID-064A301 or ID-064A302),e.g., took less than 80% of the planned doses of double-blind study treatment; or did not attend a majority of the site visits, unless there was a medically justified reason as judged by the investigator.
2. Systemic lupus erythematosus driven renal disease, central nervous system lupus, or active severe or unstable neuropsychiatric systemic lupus erythematosus where, in the judgment of the investigator, protocol-specific systemic lupus erythematosus background therapy is insufficient, and the use of a more aggressive therapeutic approach or other treatments not permitted in the protocol is indicated.
3. Women of child-bearing potential planning to become pregnant up to the final study visit.
4. Judged not eligible to participate by the investigator, for any other reason.
5. Confirmed active or latent tuberculosis (applicable only if requested by local regulations).

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 3

1. Occurrence of treatment-emergent adverse events up to the final study visit.
2. Occurrence of serious adverse events up to the final study visit.
3. Occurrence of adverse events of special interest (i.e., anticipated risks of treatment with cenerimod, known class effects, and events that may be related to systemic lupus erythematosus comorbidities) up to the final study visit.

Investigational products

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

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Viatris Innovation GmbH

Sponsor organisation

Viatris Innovation GmbH

Address

Gewerbestrasse 14

City

Allschwil

Postcode

4123

Country

Switzerland

Scientific contact point

Organisation

Viatris Innovation GmbH

Contact name

EUClinicalTrials@viatris

Public contact point

Organisation

Viatris Innovation GmbH

Contact name

EUClinicalTrials@viatris

Third parties 14

Locations

9 EU/EEA countries · 47 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 78 files

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

Application history

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