A Study to Investigate Efficacy, Safety, and Tolerability of Remibrutinib Compared With Placebo in Adults With CINDU Inadequately Controlled by H1-antihistamines
- Registration Number
- NCT05976243
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief Summary
This is a Phase 3, parallel group, placebo-controlled, double-blind, confirmatory study in patients with CINDU, with an optional Open-label Extension (OLE).
The purpose of the core period (52 weeks of treatment) of this study is to evaluate the efficacy, safety, and tolerability of remibrutinib (LOU064) vs. placebo in adults suffering from CINDU inadequately controlled by H1-antihistamines (H1-AHs).
The purpose of the OLE period is to collect long-term efficacy, safety, and tolerability data on remibrutinib in participants after having completed the Core period
- Detailed Description
This study consists of a core and extension periods.
The Core period (6 arms) has a total duration of up to 60 weeks including a double-blind placebo-controlled treatment period until Week 24 followed by open-label treatment with remibrutinib up to Week 52. The primary endpoint for all CINDU subtypes is assessed at Week 12.
The Core period consists of:
* Screening period (up to 4 weeks): During the screening period, participants who have provided informed consent will be assessed for study eligibility.
* Double-blind, placebo-controlled treatment period (24 weeks): 24 weeks of double-blind treatment with remibrutinib or placebo.
* Open-label treatment period (28 weeks): 28 weeks of open-label treatment with remibrutinib.
* Follow-up period: 4 weeks of treatment free follow-up. The open-label extension period consists of observation and treatment period. At the end of the core period of the study, if participants continue to experience symptoms, they will transition to the treatment period in OLE. If they do not experience symtpoms they will transition to the observation period in the OLE.
The duration of the Open-label Extension period will be approximately 3 years where participants can switch from observation to treatment depending on if they start developing symptoms. Only those participants participating in the Open-label Extension Treatment period will receive remibrutinib. The participants in the Open-label Extension Observation period will not receive remibrutinib
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 348
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Remibrutinib, symptomatic dermographism group Remibrutinib Remibrutinib oral twice daily in participants with symptomatic dermographism Placebo, symptomatic dermographism group Placebo Placebo oral twice daily, symptomatic dermographism Remibrutinib, cold urticaria group Remibrutinib Remibrutinib oral twice daily, cold urticaria Placebo, cold urticaria group Placebo Placebo oral twice daily, cold urticaria Placebo, cholinergic urticaria Placebo Placebo oral twice daily, cholinergic urticaria Remibrutinib, cholinergic urticaria group Remibrutinib Remibrutinib oral twice daily, cholinergic urticaria
- Primary Outcome Measures
Name Time Method Proportion of participants with complete response in critical temperature threshold; cold urticaria 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 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")Proportion of participants with complete response in Total Fric Score; symptomatic dermographism 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)
- Secondary Outcome Measures
Name Time Method Change from baseline in itch NRS in participants with symptomatic dermographism Week 2 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)
Change from baseline in itch NRS in participants with cold urticaria Week 2 Itch numerical rating scale (NRS), scale from 0 to 10. 0 ("no itch") to 10 ("worst imaginable itch").
Proportion of participants with cholinergic urticaria with PGA=0 Week 2 Physician global assessment of severity of hives is a 4-point scale (0 = no active disease, 1 = mild disease, 2 = moderate disease, 3 = severe disease).
Change from baseline in criticial temperature threshold following Temptest; cold urticaria Week 12 Critical temperature threshold, as measured by the Temptest, determines the highest temperature that induces symptoms
Change from baseline in itch numerical rating scale; cholinergic urticaria Week 12 Itch numerical rating scale (NRS), scale from 0 to 10. 0 ("no itch") to 10 ("worst imaginable itch").
Change from baseline in Critical Temperature Threshold in participants with cold urticaria Week 2 Critical temperature threshold (CTT), as measured by the Temptest, determines the highest temperature that induces symptoms.
Change from baseline in itch NRS in participants with cholinergic urticaria Week 2 Itch numerical rating scale (NRS), scale from 0 to 10. 0 ("no itch") to 10 ("worst imaginable itch").
Change from baseline in Total Fric score; symptomatic dermographism Week 12 Total Fric score, a scale from 0-4 where a positive response with all four pins is TFS=4, while a positive only 1 pin - the largest pin is TFS=1
proportion of participants with Physician Global Assessment (PGA) severity of hives =0; cholinergic urticaria Week 12 Physician global assessment of severity of hives. This assessment is scored 0 to 4 with 0=no hives, 1=mild hives, 2=moderate hives, 3=severe hives and 4=very severe hives
Proportion of participants with complete response in TFS; symptomatic dermographism Week 24 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 itch numerical rating scale; cholinergic urticaria Week 24 Itch numerical rating scale (NRS), scale from 0 to 10. 0 ("no itch") to 10 ("worst imaginable itch").
Change from baseline in itch numerical rating scale in participants with symptomatic dermographism Week 12 Itch numerical rating scale (NRS), scale from 0 to 10. 0 ("no itch") to 10 ("worst imaginable itch").
Change from baseline in itch numerical rating scale in participants with cold urticaria Week 12 Itch numerical rating scale (NRS), scale from 0 to 10. 0 ("no itch") to 10 ("worst imaginable itch").
Proportion of participants with complete response in Total Fric score; symptomatic dermographism Week 2 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 Week 2 Critical temperature threshold (CTT), as measured by the Temptest, determines the highest temperature that induces symptoms.
Proportion of participants with itch NRS=0; cholinergic urticaria Week 2 Itch numerical rating scale (NRS), scale from 0 to 10. 0 ("no itch") to 10 ("worst imaginable itch").
Change from baseline in TFS in participants with symptomatic dermographism Week 2 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 Week 24 Critical Temperature Threshold, as measured by the Temptest, is the highest temperature that induces symptoms
Change from baseline in weekly most bothersome symptom NRS score on the USDD Week 12 Urtricara symptom daily diary (USDD). This daily diary records if the participant experiences any symptoms or avoided the triggers
Occurrence of treatment emergent adverse events and serious adverse events during the study Week 52 Treatment emergent adverse events and serious adverse events are those that occur at any time only after treatment has started
Proportion of participants with DLQI=0-1 Week 12 The Dermatology Life Quality Index (DLQI) is a 10-item dermatology-specific quality of life (QoL) measure. Subjects rate their dermatology symptoms as well as the impact of their skin condition on various aspects of their lives thinking about the previous 7 days. An overall score is calculated and ranges from 0 to 30 (higher score meaning worse disease-related QoL). A DLQI score of 0 or 1 means that there is no impact of a skin disease on the patient's life.
Trial Locations
- Locations (31)
Allervie Clinical Research
🇺🇸Birmingham, Alabama, United States
Little Rock Allergy and Asthma Clnc
🇺🇸Little Rock, Arkansas, United States
Kern Research
🇺🇸Bakersfield, California, United States
Allergy and Asthma Specialists Medical Group and Research Ct
🇺🇸Huntington Beach, California, United States
Antelope Valley Clinical Trials
🇺🇸Lancaster, California, United States
Asthma and Allergy Associates P C
🇺🇸Colorado Springs, Colorado, United States
Florida Ctr Allergy Asthma Research .
🇺🇸Aventura, Florida, United States
Florida Ctr Allergy Asthma Research
🇺🇸Aventura, Florida, United States
Finlay Medical Research
🇺🇸Greenacres City, Florida, United States
Sarasota Clinical Research .
🇺🇸Sarasota, Florida, United States
Univ of South Florida Asthma Allergy and Immunology CRU
🇺🇸Tampa, Florida, United States
AeroAllergy Research Laboratories of Savannah Inc
🇺🇸Savannah, Georgia, United States
Treasure Valley Medical Research
🇺🇸Boise, Idaho, United States
Northshore University Health System Division of Dermatology
🇺🇸Glenview, Illinois, United States
Asthma and Allergy Center of Chicago S C
🇺🇸River Forest, Illinois, United States
The Indiana Clinical Trials Center
🇺🇸Plainfield, Indiana, United States
Allergy and Asthma Specialist P S C Main Center
🇺🇸Owensboro, Kentucky, United States
John Hopkins University .
🇺🇸Baltimore, Maryland, United States
Somnos Clinical Research Allergy Asthma and Immunology
🇺🇸Lincoln, Nebraska, United States
Toledo Institute of Clinical Research
🇺🇸Toledo, Ohio, United States
Allergy Asthma and Clinical Research
🇺🇸Oklahoma City, Oklahoma, United States
Allergy and Clinical Immunology Associates
🇺🇸Pittsburgh, Pennsylvania, United States
National Allergy and Asthma Research LLS
🇺🇸North Charleston, South Carolina, United States
PanAmerican Clinical Research Research
🇺🇸Brownsville, Texas, United States
Asthma and Allergy Research Assoc .
🇺🇸Dallas, Texas, United States
Western Sky Medical Research Research
🇺🇸El Paso, Texas, United States
RFSA Dermatology
🇺🇸San Antonio, Texas, United States
STAAMP Research LLC
🇺🇸San Antonio, Texas, United States
Complete Dermatology
🇺🇸Sugar Land, Texas, United States
Allergy Associates of Utah
🇺🇸Sandy, Utah, United States
Novartis Investigative Site
🇻🇳Hanoi, Vietnam