Sequential Treatment of Psoriasis With Traditional Chinese and Western Medicine

NCT05042635 | Unknown DMC

• 1 other identifier: 21Y21920100
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to objectively and standardly evaluate the clinical efficacy and safety of sequential treatment of psoriasis with traditional Chinese and Western medicine through a multi-center, randomized, double-blind, placebo-controlled trial.

Conditions

Plaque Psoriasis

Keywords

Plaque Psoriasis; Ixekizumab; Jueyin granules; Randomized controlled trial; Traditional Chinese medicine

Outcome Measures

Primary Outcomes (1)

• Psoriasis area and severity index (PASI)

  Psoriasis area and severity index (PASI) score and recurrence assessment. Psoriasis area and severity index (PASI) scores were assessed for all patients at each follow-up. Recurrence was defined as a 50% reduction in maximum PASI improvement from baseline at week 40.

  Up to 168 days after treatment

Secondary Outcomes (6)

• Body surface area (BSA)

  Up to 168 days after treatment

• Physician Global Assessment (PGA)

  Up to 168 days after treatment

• Dermatology Life quality index(DLQI)

  Up to 168 days after treatment

• Patient-reported quality of life (PRQoL)

  Up to 168 days after treatment

• Visual Analogue Score (VAS)

  Up to 168 days after treatment

Study Arms (2)

Ixekizumab (4 weeks) + Jueyin Granules (12 weeks)

EXPERIMENTAL

Subjects received Ixekizumab in the first 4 weeks (biologic treatment period); After the cessation of biologic treatment, only Jueyin Granules was used in the 12-week traditional Chinese medicine treatment period.

Drug: Ixekizumab+Jueyin Granules

Ixekizumab (4 weeks) + Jueyin placebo Granules(12 weeks)

PLACEBO COMPARATOR

Subjects received Ixekizumab in the first 4 weeks (biologic treatment period); After the cessation of biologic treatment, only Jueyin placebo Granules was used in the 12-week traditional Chinese medicine treatment period.

Drug: Ixekizumab+Jueyin placebo Granules

Interventions

Ixekizumab+Jueyin Granules DRUG

Ixekizumab：160mg was injected subcutaneously at week 0 (80mg twice), then 80mg at week 2 and 4 (once). Jueyin Granules：Put each bag of daily dose into the same container, pour about 50ml warm water into it, stir until the particles are basically dissolved, then add proper amount of boiling water to dilute it, take it warm in two times.

Ixekizumab (4 weeks) + Jueyin Granules (12 weeks)

Ixekizumab+Jueyin placebo Granules DRUG

Ixekizumab：160mg was injected subcutaneously at week 0 (80mg twice), then 80mg at week 2 and 4 (once). Jueyin placebo Granules：Put each bag of daily dose into the same container, pour about 50ml warm water into it, stir until the particles are basically dissolved, then add proper amount of boiling water to dilute it, take it warm in two times.

Ixekizumab (4 weeks) + Jueyin placebo Granules(12 weeks)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• It conforms to the western diagnostic criteria of plaque psoriasis and the diagnostic criteria of TCM syndrome of blood heat syndrome;
• Physician global assessment (PGA) ≥3, psoriasis area and severity index (PASI) score ≥12, and body surface area (BSA) ≥ 10% at screening and baseline;
• Aged between 18 and 70;
• Those who voluntarily participate in the study and sign the informed consent.

You may not qualify if:

• Erythrodermic psoriasis patients, arthropathic psoriasis patients, pustular psoriasis patients;
• There are other active skin diseases that may affect the evaluator;
• Have systematically received other investigational drugs within 1 month;
• Received external glucocorticoid and phototherapy within 2 weeks;
• During a period of severe and uncontrollable local or systemic acute or chronic infection;
• Infected persons with tuberculosis;
• Patients with viral hepatitis;
• Serious systemic disease; Or clinical test indicators belong to one of the following cases of patients: alanine aminotransferase or glutamic-oxalacetic transaminase increase \> 1.5 times the upper limit of normal value; Creatinine increase \> 1.5 times the upper limit of normal value; Any one of the major blood routine indicators (white blood cell count, red blood cell count, hemoglobin amount, platelet count) is lower than the lower limit of normal value; Or other abnormal laboratory tests determined by the investigator to be unsuitable for the study;
• Patients with a history of malignant tumor and patients with primary or secondary immune deficiency and hypersensitivity;
• Participants in clinical trials of other drugs within 3 months;
• Those who have undergone major surgery within 8 weeks or will require such surgery during the study period;
• For fertile women of childbearing age who did not use highly effective contraception from the screening period until the end of the last dose;
• Pregnant or lactating women;
• Persons with a history of alcohol, drug or substance abuse;
• Persons with a serious history of mental illness or family history;

Sponsors & Collaborators

• Shanghai Yueyang Integrated Medicine Hospital: lead
• Shanghai Skin Disease and Venereal Disease Hospital: collaborator

Study Officials

• Bin Li

  Shanghai Skin Disease Hospital, School of Medicine, Tongji University

  STUDY CHAIR

Central Study Contacts

Bin Li

CONTACT

0086-0021-55981301; 18930568129@163.com

Xin Li

CONTACT

0086-13661956326; 13661956326@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2021
• First Posted: September 13, 2021
• Study Start: October 1, 2021
• Primary Completion: September 30, 2024
• Study Completion: September 30, 2024
• Last Updated: September 13, 2021

Record last verified: 2021-09