Hidradenitis Suppurativa
Conditions
Keywords
BTK inhibitor, hidradenitis suppurativa, HiSCR, remibrutinib, Phase 3, extension study
Brief summary
The purpose of this study is to evaluate the long-term safety, tolerability and efficacy of remibrutinib (LOU064) in adult participants with moderate to severe hidradenitis suppurativa (HS) who have completed either of the preceding Phase 3 studies, CLOU064J12301 or CLOU064J12302.
Detailed description
This is a global Phase 3, multicentre, double-blind, double-dummy, parallel-group extension study. It fulfils the Novartis commitment to provide post-trial access. The study includes a double-blind and an open-label treatment phase: Double-blind, double-dummy treatment continues from Week 68 (end of core study) until final database lock (DBL) of both core studies or until up titration. Participants remain on the same blinded regimen they were on during Treatment Period 2 of the preceding Phase 3 studies. After final DBL of both core studies, treatment transitions to open-label. Participants will continue treatment until commercial availability and reimbursement in their country, another access mechanism is available, or 4 years of extension treatment is completed. Participants who discontinue treatment early or do not transition to commercial remibrutinib will enter a 4-week treatment-free safety follow-up.
Interventions
DRUGRemibrutinib
Remibrutinib Dose A and B (oral)
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Signed informed consent must be obtained before any assessment is performed. * Participant has completed the full study treatment period according to the protocol (68 weeks) in the core studies (CLOU064J12301 or CLOU064J12302). * Participant does not meet any treatment discontinuation criteria of the core study at Week 68. Key
Exclusion criteria
* Ongoing or planned use of prohibited HS or non-HS treatments. * 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. * Current severe progressive or uncontrolled disease, which in the judgment of the Investigator renders the participant unsuitable for the study. Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) | Baseline, up to Week 280 | Evaluate the safety of long-term treatment with remibrutinib in adult participants with moderate to severe Hidradenitis Suppurativa. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of participants with AN50/75/90 response | Baseline, up to Week 276 | Achievement of AN50/75/90 is defined as at least a 50/75/90 (respectively)% decrease in Abscess and Inflammatory Nodule (AN) count compared to baseline. |
| Mean Percentage change from baseline in International Hidradenitis Suppurativa severity score system (IHS4) | Baseline, up to Week 276 | The IHS4 is a disease severity score calculated as a weighted sum of inflammatory lesion counts: nodules (×1), abscesses (×2), and draining tunnels (×4). Scores are categorised as mild (≤3), moderate (4-10), and severe (≥11). Higher scores indicate greater disease severity (worse outcome). |
| Proportion of participants with Hidradenitis suppurativa clinical response (HiSCR)50/75/90 response | Baseline, up to Week 276 | Achievement of HiSCR50/75/90 is defined as at least a 50/75/90 (respectively)% decrease in AN count with no increase in the number of abscesses and in the number of draining tunnels/fistulae compared to baseline. |
| Proportion of participants with clinical response in HS-related skin pain (numerical rating scale [NRS] 30), at worst | Baseline, up to Week 276 | Achievement of NRS30 among participants with baseline NRS ≥ 3 (in the core studies CLOU064J12301 and CLOU064J12302). NRS30 is defined as at least a 30% reduction and at least 2-unit reduction from baseline in Patient's Global Assessment of Skin Pain - at worst over the past 7 days. |
Countries
Argentina, Australia
Contacts
CONTACTNovartis Pharmaceuticals
Outcome results
None listed