A US Phase 3b, Multi-center, Randomized, Double-blind, Double-Dummy Study to Evaluate Efficacy of Remibrutinib Compared to Dupilumab at Early Timepoints in Adults With Chronic Spontaneous Urticaria Inadequately Controlled by Second Generation H1-Antihistamines
Novartis Pharmaceuticals
Summary
This is a US, multi-center, randomized, double-blind, double-dummy, Phase 3b study to evaluate efficacy of remibrutinib (25 mg twice daily \[b.i.d.\] by mouth \[p.o.\]) compared to dupilumab (600 mg loading dose administered subcutaneously (s.c.) followed by 300 mg every 2 weeks s.c.) at early timepoints (4 weeks and earlier), when administered as an add-on treatment to second generation H1-antihistamines (sgH1-AH) (standard label dose as background therapy) in adult US participants with moderate to severe chronic spontaneous urticaria (CSU) inadequately controlled by sgH1-AHs.
Description
This study consists of a screening period (up to 4 weeks), a core treatment period (12 weeks double-blind, double-dummy), an optional open-label extension \[OLE\] period, and safety follow-up period. Screening period: participants will have a screening period of a minimum of 7 days up to a maximum of 28 days to establish eligibility for the study. Participants meeting all the inclusion criteria and none of the exclusion criteria will be eligible to participate in the study. Core treatment period (double-blind, double-dummy): approximately, 400 participants diagnosed with CSU inadequately con…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Adults ≥ 18 years of age at the time of signing the informed consent * CSU duration for ≥ 6 months prior to screening (defined as the onset of CSU determined by the Investigator based on all available supporting documentation) * Diagnosis of CSU inadequately controlled by sgH1-AH at the time of randomization, defined as: * The presence of itch and hives for ≥ 6 consecutive weeks prior to screening despite the use of sgH1-AH during the 7 days prior to randomization (Day 1): * UAS7 score (range, 0-42) ≥ 16, and * ISS7 score (range, 0-21) ≥ 6, and * HSS7 score (range, 0-21)…
Interventions
- DrugRemibrutinib
Film-coated tablet, oral administration, 25 mg b.i.d.
- DrugRemibrutinib matching placebo
Film-coated tablet, oral administration, b.i.d.
- DrugDupilumab
Solution for injection in pre-filled syringe 600 mg loading dose followed by 300 mg dose every 2 weeks
- DrugPlacebo solution for injection
Solution for injection in pre-filled syringe every 2 weeks
Locations (114)
- Allervie Clinical ResearchBirmingham, Alabama
- Cahaba Derm and skin hlth ctr 27Birmingham, Alabama
- Research Solutions of ArizonaLitchfield Park, Arizona
- Peak DermatologyPayson, Arizona
- Premier Allergy Asthma And ImmunologyPhoenix, Arizona
- Avacare Center for DermatologyPhoenix, Arizona