24 Weeks Double-blind Randomized Placebo-controlled Trial to Evaluate Efficacy, PK, Safety of LOU064 in Adolescents (12 - <18) With CSU and Inadequate Response to H1-antihistamine Followed by Optional 3 Years Open-label Extension and an Optional 3 Years Safety Long-term Treatment-free Follow-up

Part of paid clinical trials in Bakersfield, California.

Sponsor
Novartis Pharmaceuticals
Study ID
NCT05677451
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

  • Chronic Spontaneous Urticaria

Eligibility Criteria

Sex
ALL
Age
12 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • LOU064 (blinded) — DRUG
    LOU064 (blinded) active treatment
  • placebo — DRUG
    matching active drug

Study Details

The purpose of this trial is: 1. to assess the efficacy, pharmacokinetics, and safety of remibrutinib vs. placebo in adolescents from 12 to \< 18 years of age suffering from chronic spontaneous urticaria inadequately controlled by H1-antihistamines 2. to collect long-term efficacy, safety and tolerability data on remibrutinib in adolescents after having completed 24 weeks of treatment 3. to collect safety data in this population for up to three years after the last dose of study treatment

Key Dates

Start date
Jul 11, 2023
Status verified
Jun 2026
Primary completion
Nov 6, 2026
Completion
Mar 30, 2032

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1: LOU064 (blinded)
    LOU064 (blinded) taken orally b.i.d. for 24 weeks, followed by LOU064 (open-label) taken orally b.i.d. for up to 6 cycles of 24 weeks.
  • Placebo Comparator: Arm 2: LOU064 placebo (blinded)
    LOU064 placebo (blinded) taken orally b.i.d. for 24 weeks (randomized in a 2:1 ratio arm 1: arm 2)

Primary Outcome Measure

Change from baseline in UAS7 [ Time Frame: Baseline, week 12 ]

Central Contacts

  • Novartis Pharmaceuticals
    1-888-669-6682
    [email protected]
  • Novartis Pharmaceuticals
    +41613241111

Locations (12)

FacilityCityStateZIPSite coordinators
Kern ResearchBakersfieldCalifornia93301
Wandy Noriega
[email protected]
661-864-7710
Eric Boren (PRINCIPAL_INVESTIGATOR)
Allergy and Asthma Medical Group and Research CenterSan DiegoCalifornia92123
Susan Smith
[email protected]
858-268-2368
Bob Geng (PRINCIPAL_INVESTIGATOR)
Pediatric Dermatology of Miami at the Pediatric CoEMiamiFlorida33156
Andrea Marin
[email protected]
305-667-3152
Mercedes E Gonzalez (PRINCIPAL_INVESTIGATOR)
Treasure Valley Medical ResearchBoiseIdaho83706-
Endeavor HealthGlenviewIllinois60077-
Allergy and Asthma Specialist P S COwensboroKentucky42301
Angela Haynes
[email protected]
270-684-6144
Lee Clore (PRINCIPAL_INVESTIGATOR)
Toledo Institute of Clinical ResearchToledoOhio43617-
Allergy Asthma and Clinical ResearchOklahoma CityOklahoma73120
Meryem Assaoui
[email protected]
405-752-0393
Martha Tarpay (PRINCIPAL_INVESTIGATOR)
Allergy and Clinical Immunology AssociatesPittsburghPennsylvania15241-
RFSA DermatologySan AntonioTexas78213
Jonathan Joseph
[email protected]
Lindsey Finklea (PRINCIPAL_INVESTIGATOR)
Allergy Associates of UtahSandy CityUtah84093-
Seattle Allergy and Asthma RschSeattleWashington98115-

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Kern Research· Bakersfield, CAAllergy and Asthma Medical Group and Research Center· San Diego, CAPediatric Dermatology of Miami at the Pediatric CoE· Miami, FLTreasure Valley Medical Research· Boise, IDEndeavor Health· Glenview, ILAllergy and Asthma Specialist P S C· Owensboro, KY

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