A Phase 3 extension study to assess the long-term safety and efficacy of remibrutinib in adult participants with moderate to severe hidradenitis suppurativa

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Novartis Pharma AG

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Immune System Diseases [C20]

Decision date (initial)

2026-05-20

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Novartis Pharma AG

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Safety, Others, Efficacy

Evaluate the safety of long-term treatment with remibrutinib in adult participants with moderate to severe HS

Secondary objectives 1

1. Evaluate the long-term observed efficacy of remibrutinib dose regimens during year 1 and after year 1 of the extension study with respect to participants with moderate to severe HS: • Proportion of participants with AN50/75/90 response • Mean percentage change from baseline in IHS4 • Proportion of participants with HiSCR 50/75/90 response • Proportion of participants with clinical response in HS-related skin pain (NRS30), at worst

Conditions and MedDRA coding

Hidradenitis Suppurativa (HS)

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. Signed informed consent must be obtained before any assessment is performed.
2. Ability to communicate effectively with the Investigator, to understand and willing to comply with the requirements of the study
3. Participant has completed the full study treatment period according to the protocol (68 weeks) in the core studies (CLOU064J12301 or CLOU064J12302).
4. Participant does not meet any treatment discontinuation criteria of the core study at Week 68

Exclusion criteria 5

1. Ongoing or planned use of prohibited HS or non-HS treatments
2. Participants not expected to benefit from participation in the extension study, or participants expected to be exposed to an undue safety risk if participating in the extension study, as assessed by the Investigator.
3. Current severe progressive or uncontrolled disease which in the judgment of the Investigator renders the participant unsuitable for the study
4. Pregnant or lactating women or female participants who are planning to become pregnant during the study or within 4 weeks following the final dose of study treatment
5. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant from menarche until becoming post-menopausal, unless they are using highly effective methods of contraception (failure rate < 1% per year) while taking study treatment and for 7 days after stopping study treatment. Women are considered post-menopausal if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g., hormonal profile confirming menopause and/or age-appropriate history of vasomotor symptoms).

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Occurrence of treatment-emergent Adverse Events (TEAEs)

Secondary endpoints 1

1. • Achievement of AN50/75/90. • Percentage change from baseline in IHS4 • Achievement of HiSCR50/75/90. • Achievement of NRS30 among participants with baseline NRS ≥ 3 (in the main studies).

Investigational products

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

Test 2

Placebo 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Novartis Pharma AG

Sponsor organisation

Novartis Pharma AG

Address

Lichtstrasse 35

City

Basel

Postcode

4056

Country

Switzerland

Scientific contact point

Organisation

Novartis Pharma AG

Contact name

Novartis Pharma Arzneimittel GmbH

Public contact point

Organisation

Novartis Pharma AG

Contact name

Novartis Pharma Arzneimittel GmbH

Third parties 5

Locations

12 EU/EEA countries · 105 investigational sites

By country

Investigational sites

Results and documents

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

Documents 127 files

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

Application history

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