Doctor examining a patient's arm during a clinical visit

How SD efficacy and
safety were evaluated

HCP and CSU patient portrayal.

RHAPSIDO^® was studied in adult patients with symptomatic dermographism (SD) who remained symptomatic despite H1 antihistamine treatment¹

Study design diagram of RemIND trial showing adults with symptomatic dermographism randomized to receive Rhapsido 25mg plus H1 antihistamine, with a 12-week double-blind phase (primary endpoint at week 12) followed by a 24-week open-label Rhapsido treatment through week 52.

Primary end point was the proportion of patients with complete response to TFS (TFS=0) following the FricTest^® 4.0 at week 12.¹

The RemIND trial included an open-label period. Efficacy is based on results from 115 patients treated during the 24-week placebo-controlled period.¹

*TFS of ≥3 (range 0-4) using the Fric test and a NRS score of ≥5 (range 0-10) for itch 10 minutes after the provocation test.
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Key inclusion criteria²

Key exclusion criteria²

Baseline characteristics

Disease characteristics

Study end points¹

Complete response based on TFS (TFS=0) at week 12

Chart showing primary end point. LS mean CFB in TFS at week 12* Rhapsido -1.56; Placebo -0.88

*Multiple imputation techniques were implemented for missing data.¹

Secondary end points included⁴:

CFB in TFS following the Fric test at week 12
Proportion of participants with complete response to TFS following the Fric test at week 24
CFB in itch NRS following the Fric test at week 12
Proportion of participants with complete response in TFS following the Fric test at week 2
CFB in TFS following the Fric test at week 2
CFB in itch NRS following the Fric test at week 2
CFB in the weekly MBS NRS score on the USDD at week 12

Complete response based on TFS in SD¹

See Efficacy Data

Demonstrated safety profile¹

See Safety Data

BID, twice a day; CFB, change from baseline; CSU, chronic spontaneous urticaria; H1, histamine H1 receptor; ICF, informed consent form; LS, least squares; MBS, most bothersome symptom; NRS, numerical rating scale; SD, symptomatic dermographism; TFS, Total Fric Score; USDD, Urticaria Symptom Daily Diary.

References: 1. Rhapsido. Prescribing information. Novartis Pharmaceuticals Corp. 2. Data on file. CLOU06M12301 Clinical Trial Protocol. Novartis Pharmaceuticals Corp; June 2023. 3. Lee R, Bernstein JA. Chronic spontaneous urticaria and chronic inducible urticaria. J Allergy Clin Immunol. 2025;156(3):546-556. doi:10.1016/j.jaci.2025.05.019. 4. Data on file. CSR Study No. CLOU064M12301: Week 24 analysis for symptomatic dermographism cohort. Novartis Pharmaceuticals Corp; April 2025.