JMIR Publications

Background:

Psoriasis is a chronic, immune-mediated inflammatory disease characterized by recurrent episodes, with plaque psoriasis being the most prevalent subtype and a major cause of impaired quality of life. Secukinumab, an interleukin-17A inhibitor, is a widely used biologic therapy for moderate-to-severe psoriasis and other inflammatory disorders, demonstrating rapid and robust efficacy. However, disease relapse following biologic discontinuation remains a substantial clinical challenge. Huashixiaoyin Decoction (HSXYD) is a traditional Chinese herbal formula commonly used in clinical practice for plaque psoriasis, particularly in patients with dampness-heat–related syndromes, and is believed to exert anti-inflammatory and immunomodulatory effects. Preliminary clinical observations suggest that HSXYD may help stabilize disease control and reduce relapse after biologic therapy, although its efficacy has yet to be validated in randomized controlled trials.

Objective:

This study aims to evaluate the efficacy and safety of HSXYD in combination with Secukinumab for the treatment of moderate-to-severe plaque psoriasis, and to explore its potential in preventing relapse.

Methods:

This prospective, multicentre, double-blind randomized controlled trial adopts a two-arm, parallel-group design. A total of 128 eligible participants have been randomized (1:1) to either the intervention group (secukinumab for 24 weeks combined with HSXYD for the first 8 weeks) or the control group (secukinumab for 24 weeks combined with Chinese herbal placebo). The primary outcome is time to relapse during the follow-up period (weeks 24–48). Secondary outcomes include changes in Psoriasis Area and Severity Index, Investigator’s Global Assessment, Dermatology Life Quality Index, percentage of body surface area affected, and symptom scores based on traditional Chinese medicine syndrome differentiation. Time-to-event outcomes will be analyzed using Kaplan–Meier methods and Cox proportional hazards models, while continuous outcomes will be analyzed using mixed-effects models based on the intention-to-treat principle. Safety will be closely monitored throughout the study. Patients and the public were not involved in the design, conduct, reporting, or dissemination.

Results:

This study was supported financially by the National High LevelHospital Clinical Research Funding of China. The trial was registered in December 2024. Participant recruitment has been completed. The follow-up will be completed by April 2026. Data analysis is anticipated to be completed by May 2026. The results will be disseminated at national and international conferences and published in peer-reviewed journals.

Conclusions:

This randomized controlled trial will provide evidence on the efficacy and safety of Huashixiaoyin Decoction as an adjunct to secukinumab in moderate-to-severe plaque psoriasis. By targeting disease stability beyond active biologic treatment, this study may offer a novel integrative strategy to sustain long-term remission and reduce relapse after biologic discontinuation.

ClinicalTrial:

This trial was registered in the International Traditional Medicine Clinical Trial Registry(ITMCTR, https://www.chictr.org.cn/) on December 3, 2024. Clinical Trial Number: ITMCTR2025000129.