Evidence map›Paper›PMID 41854973›Full record

ArticleDermatology and therapy2026

Efficacy of Remibrutinib versus Dupilumab at Early Timepoints in Chronic Spontaneous Urticaria: US Phase 3b Study Design (RECLAIM).

Gil Yosipovitch, Giselle Mosnaim, Christine-Elke Ortmann, Nicole Griswold, Jane Mast, El-Djouher Martzloff, Jonathan Rodrigues, Jason E Hawkes

Registry-linked trialAbstract read
In one paragraph

Article in Dermatology and therapy, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06868212 (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), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT06868212 phase3recruitingnot on this map

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

TypeinterventionalSponsorNovartis PharmaceuticalsRan2025 to 2027Enrolled400ConditionsChronic Spontaneous Urticaria (CSU)ArmsRemibrutinib, Remibrutinib matching placebo, Dupilumab, Placebo solution for injection
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Review
  2. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors.

Gil YosipovitchDr. Phillip Frost Department of Dermatology and Cutaneous Surgery, University of Miami Miller School of Medicine, Miami, FL, USA. gyosipovitch@med.miami.edu.
Giselle MosnaimDivision of Allergy and Immunology, Department of Medicine, Endeavor Health, Evanston, IL, USA.
Christine-Elke OrtmannNovartis Pharma AG, Basel, Switzerland.
Nicole GriswoldNovartis Pharmaceuticals Corporation, East Hanover, NJ, USA.
Jane MastNovartis Pharmaceuticals Corporation, East Hanover, NJ, USA.
El-Djouher MartzloffNovartis Pharma AG, Basel, Switzerland.
Jonathan RodriguesNovartis Pharmaceuticals Corporation, East Hanover, NJ, USA.
Jason E HawkesOregon Medical Research Center, Portland, OR, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionRemibrutinib, an oral, highly selective Bruton's tyrosine kinase (BTK) inhibitor, was recently approved by the US Food and Drug Administration (FDA) for the treatment of chronic spontaneous urticaria (CSU). Dupilumab, an interleukin-4 receptor-α monoclonal antibody, was approved by the FDA for CSU in early 2025. Here, we report the design of RECLAIM (NCT06868212), a phase 3b study that aims to compare the efficacy of remibrutinib and dupilumab at early timepoints in patients with symptomatic CSU despite treatment.

methodsThis US-based, multicenter, randomized, double-blind, double-dummy study will include approximately 400 patients with moderate-to-severe CSU who remain symptomatic despite treatment with second-generation H PLANNED OUTCOMES: RECLAIM will evaluate the early efficacy of remibrutinib versus dupilumab in patients with CSU. The study is currently recruiting patients.

trial registrationClinicalTrials.gov identifier, NCT06868212.

Indexed as

BTK inhibitorChronic spontaneous urticariaDupilumabHives Severity ScoreItch Severity ScoreRemibrutinibUrticariaUrticaria Activity Score

Identifiers

PMID41854973
PMCPMC13219691

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.