A Phase III Study of SYHX1901 Tablets in the Treatment of Moderate to Severe Plaque Psoriasis

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-65
SponsorCSPC Ouyi Pharmaceutical Co., Ltd.

About this trial

The purpose of this study is to evaluate the efficacy and safety of different doses of SYHX1901 tablets in the treatment of moderate to severe plaque psoriasis.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Subject must be diagnosed of chronic plaque psoriasis with no morphological changes or significant outbreaks of disease activity assessed by the investigator;

Subject must be a candidate for systemic treatment or phototherapy assessed by the investigator;

Body Surface Area (BSA) affected by plaque-type psoriasis ≥10% at screening and baseline;

PASI score of ≥10 and Static Physician's Global Assessment (sPGA) score ≥3 at screening and baseline; 4. Negative blood pregnancy results should be provided 7 days (inclusive) prior to randomization, and subjects and their partners should voluntarily take contraceptive measures considered effective by the investigator during the study period and for at least 28 days after the study; 5. Subjects must be volunteer and be able to complete study procedures and follow-up examinations.

Disqualifiers

Forms of psoriasis other than plaque psoriasis (Guttate psoriasis、erythrodermic psoriasis、Pustular psoriasis、Drug-induced psoriasis);

Previous or current autoimmune disease that may affect the clinical evaluation of psoriasis;

Other active skin conditions that may affect the clinical evaluation of psoriasis;

Active bacterial, viral, fungal, or other infection that requires medical intervention;

Trial design

Design model

Parallel

Treatments tested in this trial

  • SYHX1901

    Drug

    Administered orally, once daily (QD)

Treatment groups

500 Participants
are divided into 3 treatment groups
Group A: SYHX1901 dose 1Experimental treatment 1 intervention
Group B: SYHX1901 dose 2Experimental treatment 1 intervention
Group C: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Title: The Number of Participants With a Static Physician's Global Assessment (sPGA) Score of 0 or 1 in Participants Receiving SYHX1901 Compared to Placebo at Week 16 (sPGA 0/1) Description: The sPGA is a 5-point scale of an average assessment of all

Time frame
Week 16
2

Title: The Number of Participants Who Achieve a 75% Improvement From Baseline in the Psoriasis Area and Severity Index (PASI) Score in Participants Receiving SYHX1901 Compared to Placebo at Week 16 (PASI 75) Description: PASI is a measure of th

Time frame
Baseline and Week 16

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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