Health TrialsbyHealthPanel

Efficacy and Safety of Jiuweihuaban Pill for Treating Plaque Psoriasis

ConditionPlaque Psoriasis
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorTasly Pharmaceutical Group Co., Ltd

About this trial

This study will evaluate the efficacy and safety of Jiuweihuaban Pill in the treatment of moderate to severe plaque psoriasis(syndrome of blood-heat ).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Aged 18-65, male or female.

The diagnosis of plaque psoriasis vulgaris was in accordance with the western diagnostic criteria

Conformed to the TCM syndrome differentiation standard of plaque psoriasis with Blood-heat syndrome.

At screening period: 3 ≤PASI≤ 20, 3%≤BSA≤ 10% and sPGA≥2.

Disqualifiers

Psoriasis caused by drug-induced factors; combined with non-plaque Psoriasis at screening (such as guttate,arthropathica, pustular, erythrodermic and other types of Psoriasis); The skin lesions are exclusively observed in subjects with specific areas such as the face, scalp, nails, skin folds, glans penis, mucous membranes, palms, and soles.

Systemic therapy with non-biological drugs within 4 weeks prior to randomization, including but not limited to systemic corticosteroids, retinoids, methotrexate, and cyclosporine.

Systemic therapy with biological drugs within 12 weeks or 5 half-lives (whichever is longer) prior to randomization, including but not limited to interleukin antibodies (such as ustekinumab, secukinumab) and tumor necrosis factor-alpha antagonists (such as etanercept, infliximab, adalimumab) in the study.

Topical anti-psoriatic treatment received within 2 weeks prior to randomization, including retinoids, vitamin D3 derivatives, corticosteroids, and others

Trial design

Design model

Parallel

Treatments tested in this trial

  • Jiuweihuaban Pill placebo

    Drug

    Jiuweihuaban pill placebo 1 bag(12 g placebo per bag),p.o.,tid,for 12weeks.

  • low dose Jiuweihuaban Pill

    Drug

    Low dose Jiuweihuaban pill 1 bag(3 g placebo per bag and 9 g Jiuweihuaban pill ),p.o.,tid,for 12weeks.

  • high dose Jiuweihuaban Pill

    Drug

    High dose Jiuweihuaban pill 1 bag(12 g Jiuweihuaban pill ),p.o.,tid,for 12weeks.

Treatment groups

180 Participants
are divided into 3 treatment groups
Group A: Placebo groupPlacebo comparator 1 intervention
Group B: Low dose groupExperimental treatment 1 intervention
Group C: High dose groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

PASI 75

Proportion of subjects achieving an improvement of ≥75% in Psoriasis Area and Severity Index (PASI75) from baseline at days84.

Time frame
Baseline to days 84.

Secondary outcomes

1

PASI75

Proportion of subjects achieving an improvement of ≥75% in Psoriasis Area and Severity Index (PASI75) from baseline at days 28、56.

Time frame
Baseline to days 28、56.
2

PASI50、90

Proportion of subjects achieving an improvement of ≥50% and ≥90% in Psoriasis Area and Severity Index (PASI50, PASI90) from baseline at days 28、56、84.

Time frame
Baseline to days 28、56、84.
3

Change value and percentage change in PASI score

Change value and percentage change in PASI score from baseline at days 84.The PASI scores can range from 0, corresponding to no signs of psoriasis, up to a theoretic maximum of 72.0, corresponding to maximal signs of psoriasis.

Time frame
Baseline to days 84.
4

Proportion of subjects achieving sPGA=0 or 1

Proportion of subjects achieving clear (score of 0) or almost clear (score of 1) in static Physician Global Assessment (sPGA=0 or 1) at Weeks 4, 8, and 12.

Time frame
Baseline to days 28、56、84.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tasly Pharmaceutical Group Co., Ltd

Lead sponsor

Source ClinicalTrials.gov
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