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Remibrutinib, cold urticaria group for Chronic Urticaria

Phase 3

Recruiting

Research Sponsored by Novartis Pharmaceuticals

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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.

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.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 52

Awards & highlights

Study Summary

This trial tests if a drug (remibrutinib) can help adults with CINDU, a condition inadequately controlled by antihistamines. Results will show safety, efficacy, & tolerability.

Who is the study for?

Adults over 18 with Chronic Inducible Urticaria (CINDU) not well-managed by antihistamines can join. They must have a confirmed CINDU diagnosis for at least 4 months and meet specific test criteria showing their condition's severity.Check my eligibility

What is being tested?

The trial is testing Remibrutinib against a placebo in adults with CINDU. It's double-blind, meaning neither the patients nor doctors know who gets what treatment. After 52 weeks, there's an option to enter a long-term study phase.See study design

What are the potential side effects?

While the side effects of Remibrutinib are not detailed here, common ones may include reactions at the injection site, headaches, gastrointestinal issues, and potential allergic responses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My doctor says my hives are moderate to severe, and I feel a lot of itchiness.

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I have severe skin writing with itching scored high on a specific test.

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I have been diagnosed with a chronic skin condition for over 4 months and treatments haven't worked well.

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I sweat during exercise tests and do not have a condition stopping me from sweating.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 52

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 52

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 52 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Proportion of participants with complete response in Total Fric Score; symptomatic dermographism

Proportion of participants with complete response in critical temperature threshold; cold urticaria

Proportion of participants with itch numerical rating scale =0; cholinergic urticaria

Secondary outcome measures

Change from baseline in Critical Temperature Threshold in participants with cold urticaria

Change from baseline in TFS in participants with symptomatic dermographism

Change from baseline in Total Fric score; symptomatic dermographism

+18 more

Trial Design

6Treatment groups

Experimental Treatment

Placebo Group

Group I: Remibrutinib, symptomatic dermographism groupExperimental Treatment1 Intervention

Remibrutinib oral twice daily in participants with symptomatic dermographism

Group II: Remibrutinib, cold urticaria groupExperimental Treatment1 Intervention

Remibrutinib oral twice daily, cold urticaria

Group III: Remibrutinib, cholinergic urticaria groupExperimental Treatment1 Intervention

Remibrutinib oral twice daily, cholinergic urticaria

Group IV: Placebo, cholinergic urticariaPlacebo Group1 Intervention

Placebo oral twice daily, cholinergic urticaria

Group V: Placebo, cold urticaria groupPlacebo Group1 Intervention

Placebo oral twice daily, cold urticaria

Group VI: Placebo, symptomatic dermographism groupPlacebo Group1 Intervention

Placebo oral twice daily, symptomatic dermographism

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor

2,860 Previous Clinical Trials

4,197,961 Total Patients Enrolled

28 Trials studying Chronic Urticaria

9,124 Patients Enrolled for Chronic Urticaria

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research endeavor presently enrolling participants?

"Affirmative. Data hosted on clinicaltrials.gov confirms that this medical research, which was initially posted on December 19th 2023, is currently recruiting individuals to participate in the trial. Approximately 348 participants are needed from 1 distinct testing centre."

Answered by AI

What is the approximate number of participants in this clinical research study?

"Affirmative. Per the particulars on clinicaltrials.gov, this research project is presently searching for participants and was first posted on December 19th 2023 with its most recent update taking place a fortnight ago. 348 patients are sought from one location."

Answered by AI

What risks are associated with the use of Remibrutinib in patients with cold urticaria?

"The safety of Remibrutinib for patients with cold urticaria was assessed a 3, as there is existing data across multiple rounds that confirm its efficacy and security."

Answered by AI

What aims are researchers attempting to accomplish with this study?

"The ambition of this 12 week trial is to observe the percentage of subjects with cholinergic urticaria whose itch numerical rating scale (NRS) scores are zero. Additional goals include ascertaining the proportion of participants who have a Dermatology Life Quality Index (DLQI) score between 0 and 1, noting any modifications in Critical Temperature Thresholds among those afflicted by cold urticaria, and monitoring changes from baseline in NRS scores for individuals suffering from cholinergic urticaria."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "A Study to Investigate Efficacy, Safety, and Tolerability of Remibrutinib Compared With Placebo in Adults With CINDU Inadequately Controlled by H1-antihistamines". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05976243.

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