A Study of WD-890 in Participants With Moderate-to-Severe Plaque Psoriasis

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorZhejiang Wenda Pharma Technology LTD.

About this trial

Th purpose of the study is to evaluate the dose response of WD-890 in efficacy at Week 16 in participants with moderate-to-severe plaque psoriasis.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male or female participant aged 18 to 70 years(inclusive)at the time of informed consent.

Diagnosis of plaque psoriasis for at least 6 months prior to the screening visit.

Psoriasis Area and Severity Index (PASI) score ≥12 and static Physician's Global Assessment (sPGA) ≥3 at screening visit and randomization

Disqualifiers

Participant has a nonplaque form of psoriasis (for example, erythrodermic, guttate, inverse, pustular,or drug induced psoriasis.)

Has uncontrolled arterial hypertension characterized by a systolic blood pressure (BP) ≥160 mm Hg or diastolic BP ≥100 mm Hg Note: Determined by 2 consecutive elevated readings. If an initial BP reading exceeds this limit, the BP may be repeated once after the subject has rested sitting for ≥10 minutes. If the repeat value is less than the criterion limits, the second value may be accepted

Class III or IV congestive heart failure by New York Heart Association Criteria

Participant with a history of chronic bacterial infections (e.g., chronic pyelonephritis, chronic bronchiectasis, or chronic osteomyelitis).

Trial design

Design model

Parallel

Treatments tested in this trial

  • WD-890 tablet

    Drug

    Participants will receive WD-890 Dose 1 QD and placebo from Week 0 through Week 16. Participants will receive placebo to maintain the blinding of dose regimens.

  • WD-890 tablet

    Drug

    Participants will receive WD-890 Dose 2 QD and placebo from Week 0 through Week 16. Participants will receive placebo to maintain the blinding of dose regimens.

  • WD-890 tablet

    Drug

    Participants will receive WD-890 Dose 3 QD and placebo from Week 0 through Week 16. Participants will receive placebo to maintain the blinding of dose regimens.

  • Placebo

    Drug

    Participants will receive placebo QD from Week 0 through Week 16.

Treatment groups

140 Participants
are divided into 4 treatment groups
Group A: Group 1: WD-890 Dose 1 QD and PlaceboExperimental treatment 1 intervention
Group B: Group 2: WD-890 Dose 2 QD and PlaceboExperimental treatment 1 intervention
Group C: Group 3: WD-890 Dose 3 QD and PlaceboExperimental treatment 1 intervention
Group D: Group 4: PlaceboExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 75 Score at Week 16

Time frame
Screening up to Week 16

Secondary outcomes

Other outcomes

Sponsors and contacts

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