A multicentre sequential randomized, blinded, placebo-controlled study in adults with moderate-to-severe plaque psoriasis to evaluate whether Chinese herbal medicine, after PASI-75 response to 12-week ixekizumab induction, reduces relapse compared with matched placebo
Moderate-to-severe plaque psoriasis
This is a multicentre sequential interventional study with two stages. Stage 1 (induction stage): up to 200 eligible adults with moderate-to-severe plaque psoriasis will receive ixekizumab induction treatment for 12 weeks. Ixekizumab will be administered subcutaneously at 160 mg at Week 0, followed by 80 mg every 2 weeks until Week 12. Stage 2 (randomized stage): participants who achieve PASI75 after ixekizumab induction will be randomized centrally in a 1:1 ratio using a SAS-generated randomization schedule and a web-based central randomization system to one of two groups. Group 1: active Chinese herbal medicine. Participants will receive Guben Qushi Huayu Granules, 3 sachets orally twice daily, plus Shenling Baizhu Powder Capsules, 3 capsules orally three times daily, for 12 weeks. Group 2: matched placebo. Participants will receive placebo Guben Qushi Huayu Granules, 3 sachets orally twice daily, plus placebo Shenling Baizhu Powder Capsules, 3 capsules orally three times daily, for 12 weeks. Only the Chinese herbal medicine allocation will be blinded. Matching placebo preparations will be used so that participants, treating clinicians, and outcome assessors are unaware of whether active or placebo Chinese herbal treatment has been assigned. During the 12-week randomized treatment period, visits will occur every 2 weeks. After treatment, all randomized participants will be followed for 36 weeks with visits every 4 weeks. A 10% urea ointment may be used as background topical treatment during treatment and follow-up.
1. Adults aged 18 to 70 years 2. Diagnosis of moderate-to-severe plaque psoriasis 3. PASI score ≥7 or body surface area involvement≥10% 4. Meets the indication criteria for ixekizumab treatment 5. Willing and able to provide written informed consent
1. Pregnant or lactating women, or participants planning pregnancy during the study period 2. Inflammatory bowel disease 3. Serious uncontrolled primary disease of the respiratory, cardiovascular or other major organ systems, or serious infection, tuberculosis, hepatitis, haematological abnormality, tumour, severe electrolyte or acid-base disturbance, primary or secondary immunodeficiency, severe psychiatric disease, or any clinically significant abnormal laboratory result judged by the investigator to make participation unsuitable 4. Known allergy or hypersensitivity to any study medication or its ingredients 5. Participation in another drug clinical trial currently or within the previous 4 weeks 6. Use of Chinese medicine or topical psoriasis treatments within 2 weeks before enrolment; oral systemic therapy or ultraviolet phototherapy within 4 weeks; or biologic therapy within 5 half-lives before enrolment 7. Any other condition judged by the investigator to make the participant unsuitable for the study