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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06799000




Registration number
NCT06799000
Ethics application status
Date submitted
23/01/2025
Date registered
29/01/2025

Titles & IDs
Public title
A Phase 3 Study to Assess Efficacy Safety and Tolerability of Remibrutinib in Adult Patients With Moderate to Severe Hidradenitis Suppurativa
Scientific title
A Randomized, Double-blind, Double-dummy, Placebo-controlled, Multicenter, Phase 3 Study Assessing the Efficacy, Safety, and Tolerability of 2 Doses of Remibrutinib Over a 68-week Treatment Period in Adult Patients With Moderate to Severe Hidradenitis Suppurativa.
Secondary ID [1] 0 0
2024-513282-39-00
Secondary ID [2] 0 0
CLOU064J12301
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hidradenitis Suppurativa 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Remibrutinib Dose A
Treatment: Drugs - Remibrutinib Dose B
Treatment: Drugs - Placebo 1
Treatment: Drugs - Placebo 2

Experimental: Remibrutinib Dose A (Treatment Period 1 and 2) - Participants randomized to receive remibrutinib Dose A during Treatment Period 1 and 2

Experimental: Remibrutinib Dose B (Treatment Period 1 and 2) - Participants randomized to receive remibrutinib Dose B during Treatment Period 1 and 2

Placebo comparator: Placebo (Treatment Period 1) + remibrutinib Dose B (Treatment Period 2) - Participants randomized to receive placebo during Treatment Period 1 followed by remibrutinib dose B during Treatment Period 2


Treatment: Drugs: Remibrutinib Dose A
Remibrutinib Dose A (oral)

Treatment: Drugs: Remibrutinib Dose B
Remibrutinib Dose B (oral)

Treatment: Drugs: Placebo 1
Placebo matching to remibrutinib Dose A (oral)

Treatment: Drugs: Placebo 2
Placebo matching to remibrutinib Dose B (oral)
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Proportion of participants with Hidradenitis Suppurativa clinical response 50 (HiSCR50) at Week 16
Timepoint [1] 0 0
Week 16
Secondary outcome [1] 0 0
Proportion of participants with Abscesses and inflammatory nodules 50 (AN50) response at Week 16
Timepoint [1] 0 0
Week 16
Secondary outcome [2] 0 0
Percentage change from baseline in International Hidradenitis Suppurativa Severity Score System (IHS4) at Week 16
Timepoint [2] 0 0
From baseline up to Week 16
Secondary outcome [3] 0 0
Proportion of participants with HiSCR75 response at Week 16
Timepoint [3] 0 0
Week 16
Secondary outcome [4] 0 0
Proportion of participants experiencing Hidradenitis Suppurativa (HS) flares at Week 16
Timepoint [4] 0 0
Up to Week 16
Secondary outcome [5] 0 0
Proportion of participants with HiSCR50 response at Week 8
Timepoint [5] 0 0
Week 8
Secondary outcome [6] 0 0
Proportion of participants with HiSCR90 response at Week 16
Timepoint [6] 0 0
Week 16
Secondary outcome [7] 0 0
Proportion of participants with clinical response in HS related skin pain (NRS 30), at worst at Week 16
Timepoint [7] 0 0
Week 16
Secondary outcome [8] 0 0
Incidence of treatment emergent adverse events and serious adverse events during the study
Timepoint [8] 0 0
From randomization to end of study, assessed up to 72 weeks.

Eligibility
Key inclusion criteria
Key

1. Male and female participants = 18 years of age at the time of signing of the informed consent.
2. Diagnosis of HS based on clinical history and physical examination for at least 6 months prior to the Baseline visit.
3. Participants with moderate to severe HS defined as:

* A total of at least 5 AN count (abscesses and/or inflammatory nodules) AND
* Inflammatory lesions should affect at least 2 distinct anatomic areas (e.g., left and right axillae)

Key
Minimum age
18 Years
Maximum age
100 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Presence of more than 20 fistulae/tunnels (both draining and non-draining) in total at baseline.
2. Any active skin disease or conditions that may interfere with the assessment of HS.
3. Previous exposure to remibrutinib or other BTK inhibitors.
4. Use of other investigational drugs within 5 half-lives of enrollment, or within 30 days (for small molecules) prior to randomization, or until the pharmacodynamic effect has returned to baseline (for biologics), whichever is longer.
5. Significant bleeding risk or coagulation disorders.
6. History of gastrointestinal bleeding.
7. Requirement for anti-platelet (except for acetylsalicylic acid up to 100 mg/d or clopidogrel up to 75 mg/d) or anti-coagulant medication.
8. History or current hepatic disease.
9. Evidence of clinically significant cardiovascular, neurological, psychiatric, pulmonary, renal, hepatic, endocrine, metabolic, hematological disorders, gastrointestinal disease or immunodeficiency that, in the Investigator's opinion, would compromise the safety of the participant, interfere with the interpretation of the study results or otherwise preclude participation or protocol adherence of the participant.
10. History of hypersensitivity to any of the study drug constituents.
11. Known or suspected infectious disease that is active, chronic or recurrent which precludes the participant from participating in the trial as per investigator's assessment. These infectious diseases include and are not limited to opportunistic infections (e.g., tuberculosis, atypical mycobacterioses, listeriosis or aspergillosis) and/or known or suspected Human Immunodeficiency Virus (HIV) infection. Should it be required by local regulations and/or considered appropriate by the investigator, an HIV test can be performed to confirm eligibility.
12. History of live attenuated vaccine administration within 6 weeks prior to randomization or requirement to receive these vaccinations at any time while on study treatment.
13. Major surgery within 8 weeks prior to screening or planned surgery for the duration of the study.

Other protocol-defined inclusion/exclusion criteria may apply.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
12/03/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
19/10/2028
Actual
Sample size
Target
555
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Novartis Investigative Site - Darlinghurst
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Novartis Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Novartis Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Country 0 0
Phone 0 0
1-888-669-6682
Fax 0 0
Email 0 0
novartis.email@novartis.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06799000