Oral Chinese Herbal Medicine Concurrent With Secukinumab for Severe Plaque Psoriasis

Sponsor
Guangdong Provincial Hospital of Traditional Chinese Medicine
Study ID
NCT04414605
Phase
EARLY_PHASE1
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • Gu Ben Hua Yu Fang decoction (Chinese herbal medicine) — DRUG
    Chinese herbal formula (Gu Ben Hua Yu Fang) decoction will be orally administrated twice daily. One pack of Gu Ben Hua Yu Fang will be taken for each time. Chinese herbal medicine (Gu Ben Hua Yu Fang) will not be used on the day of receiving secukinumab injection.
  • Secukinumab Auto-Injector [Cosentyx] — DRUG
    Secukinumab will be administered by subcutaneous injection. The required dose (300 mg) is divided into two doses of 150 mg (contained in two separate syringes), which are injected at the same time. The first five doses (each consisting of 2 injections of 150 mg) are given at weekly intervals, with subsequent treatment given monthly (2 injections of 150 mg).

Study Details

The aim of this study is to determine whether oral Chinese herbal medicine in combination secukinumab is effective and safe in the treatment of severe psoriasis.

Key Dates

Start date
Jun 4, 2020
Status verified
May 2020
Primary completion
Dec 31, 2021
Completion
Dec 31, 2021

Study Design

Enrollment
10 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Chinese herbal medicine in combination with secukinumab
    Oral Chinese herbal medicine (Gu Ben Hua Yu Fang decoction) and secukinumab will be used concurrently. The treatment duration for both secukinumab and oral Chinese herbal medicine is up to 16 weeks. Secukinumab will be administered by subcutaneous injection. The required dose (300 mg) is divided into two doses of 150 mg (contained in two separate syringes), which are injected at the same time. The first five doses (each consisting of 2 injections of 150 mg) are given at weekly intervals, with subsequent treatment given monthly (2 injections of 150 mg). Chinese herbal formula (Gu Ben Hua Yu Fang) decoction will be orally administrated twice a day. One pack of Gu Ben Hua Yu Fang will be taken for each time. Chinese herbal medicine (Gu Ben Hua Yu Fang) will not be used on the day of receiving secukinumab injection.

Primary Outcome Measure

Median time to relapse [ Time Frame: Through study completion, an average of 1 year ]

Central Contacts

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