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A 52-week Multi-center, Randomized, Double-blind, Placebo Controlled, Basket Study With an Open-label Extension to Investigate the Efficacy, Safety, and Tolerability of Remibrutinib (LOU064) in Chronic Inducible Urticaria (CINDU) in Adults Inadequately Controlled by H1-antihistamines (CLOU064M12301)

A Study to Investigate Efficacy, Safety, and Tolerability of Remibrutinib Compared With Placebo in Adults With CINDU Inadequately Controlled by H1-antihistamines (CLOU064M12301)

Maruyama Hideki

Novartis Pharma. K.K.

Toranomon Hills Mori Tower 23-1, Toranomon 1-chome Minato-ku, Tokyo 105-6333, Japan

rinshoshiken.toroku@novartis.com

Maruyama Hideki

Novartis Pharma. K.K.

Toranomon Hills Mori Tower 23-1, Toranomon 1-chome Minato-ku, Tokyo 105-6333, Japan

+81-120-003-293

rinshoshiken.toroku@novartis.com

Not Recruiting

Mar. 25, 2024

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

Inclusion Criteria for core period:
1.Male and female participants >=18 years of age at the time of signing of the ICFs
2.Confirmed CINDU diagnosis (as per guidelines) for symptomatic dermographism, cold urticaria or cholinergic urticaria for >= 4 months (defined as onset of CINDU with supporting documentation (e.g medical record, clinical history, photographs)) and inadequate control with H1-AH at local label approved doses at the time of randomization
3.The following response to the provocation test for each subtype is required at the randomization visit :
- Symptomatic Dermographism : A Total Fric Score of >= 3 using the FricTest 4.0 and a numerical rating scale score of >= 5 for itch after the provocation test.
- Cold Urticaria : A Critical Threshold Temperature of >=15 celsius degree using the TempTest 4.0 and a numerical rating scale score of >= 5 for itch after the provocation test.
- Cholinergic Urticaria: A physician global assessment of severity of hives >= 2 using the Pulse-controlled ergometry test and a numerical rating scale score of >= 5 for itch after the provocation test.
4.Cold Urticaria: Positive ice-cube test resulting in hives at the provocation site for participants at Screening.
5.Cholinergic urticaria: Participants must show sweating in performing the pulse-controlled ergometry test on day of randomization. Participants with anhidrosis must not be included.

Inclusion criteria for the OLE:
1.Participants who have completed the Core period up to Week 52 and are willing to enter the OLE period

Exclusion Criteria for core period:

1. Previous use of remibrutinib or other BTK inhibitors.
2. Participants who have concomitant CSU at screening. Participants with resolved CSU at the time of screening can be included in the study.
3. Participants who have a familial form (e.g familial cold autoinflammatory syndrome, familial cold urticaria) of the target CINDU that is being considered for the participant's inclusion in this study.
4. Participants having a more defined other form of inducible urticaria than the target CINDU that is being considered for the participant's inclusion in this study.
5. Diseases, other than chronic inducible urticaria, with urticaria or angioedema symptoms including but not limited to urticarial vasculitis, erythema multiforme, cutaneous mastocytosis (urticaria pigmentosa) and hereditary or acquired angioedema
6. Any other skin disease associated with chronic itching that might influence, in the investigator's opinion, the study evaluations and results (e.g., atopic dermatitis, bullous pemphigoid, dermatitis herpetiformis, senile pruritus, etc.) or skin diseases associated with only wheals and no itch e.g asymptomatic dermographism

There are no exclusion criteria for OLE

Both

Chronic Inducible Urticaria

Drug: Remibrutinib
Remibrutinib treated groups and arms

Other: Placebo
Placebo treated groups and arms

- Proportion of participants with complete response in Total Fric Score; symptomatic dermographism [Time Frame: Week 12]
Total Fric score (a scale from 0-4 where a positive response with all of the four pins is TFS = 4, while a positive response with only one pin - the largest pin is TFS = 1)
- Proportion of participants with complete response in critical temperature threshold; cold urticaria [Time Frame: Week 12]
The Temptest is used to induce itch and hives in participants with cold urticaria. Critical temperature threshold (CTT), as measured by the Temptest, determines the highest temperature that induces symptoms.
- Proportion of participants with itch numerical rating scale =0; cholinergic urticaria [Time Frame: Week 12]
Itch numerical rating scale, a scale from 0 to 10

Patients are asked to rate itching severity based on the worst level of itching in the past 24 h using an 11-point scale from 0 ("no itch") to 10 ("worst itch imaginable")

+81-853-20-2744

Feb. 20, 2024

Yes

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 expert 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 is currently available according to the process described on www.clinicalstudydatarequest.com.

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