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Not yet recruitingNCT06926582Updated Apr 13, 2025

A Study to Evaluate Efficacy and Safety of HS-10374 for Mild-to-moderate Plaque Psoriasis

A Phase 2 interventional study of HS-10374 6mg tablets and HS-10374-matched placebo tablets in Psoriasis, sponsored by Hansoh BioMedical R&D Company. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-04-13.

Sponsored by Hansoh BioMedical R&D Company (part of Hansoh Pharmaceutical Group Company Limited) · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jul 2026, 3 months ago, but the record still lists the study as not yet recruiting.
Phase
Phase 2
Study type
Interventional
Enrollment
305
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study summary

This study has been designed to explore the clinical efficacy and safety of HS-10374 in the treatment of mild-to-moderate plaque psoriasis.

Read the detailed description

This is a 12-week, multi-center, randomized, double-blind, placebo-controlled, Phase II study. The study duration includes a 4-week screening period, a 12-week placebo-controlled treatment period, and a 4-week follow-up period. All eligible subjects will be randomly assigned in a 2:2:1 ratio to receive HS-10374 Dose 1, HS-10374 Dose 2, or placebo.

02

Conditions studied

  • Psoriasis

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03

In context

Psoriasis

1,928 studies on the registry are indexed under Psoriasis; 234 are open to participants now.

This study's planned enrollment of 305 is above the median of 70 across 1,472 interventional studies indexed under Psoriasis.

Browse Psoriasis studies →

Lead sponsor

Hansoh BioMedical R&D Company is the lead sponsor of 47 studies on the registry; 43 are open to participants now.

Browse Hansoh BioMedical R&D Company studies →All Hansoh Pharmaceutical Group Company Limited studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Male or female subjects between the ages of 18-70 years
  2. Diagnosis of plaque psoriasis for at least 6 months
  3. sPGA score of 2-3, BSA 2-15%, PASI score 2-15
  4. Subject must be inadequately controlled with, or intolerant of at least one topical therapy

Exclusion criteria

Exclusion Criteria:

  1. Diagnosis of non-plaque psoriasis or drug-induced psoriasis
  2. Recent history of infection, history or risk of serious infection
  3. Any major illness or evidence of unstable condition of major organ systems including psychiatric disease
  4. Any condition possibly affecting the PK process of the study drug
  5. Evidence of other skin conditions that would interfere with the evaluation of psoriasis
  6. History of hypersensitivity to the ingredients of study drugs, history of anaphylaxis
  7. Prior exposure to TYK2 inhibitors
  8. Have received the prohibited treatment during the protocol required washout period
  9. Any significant laboratory or procedure abnormalities that might place the subject at unacceptable risk during this study period
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
305 participants (estimated)

Study arms

  • Experimental
    HS-10374 Dose 1

    Drug: HS-10374 6mg tablets · Drug: HS-10374-matched placebo tablets

  • Experimental
    HS-10374 Dose 2

    Drug: HS-10374 6mg tablets

  • Placebo comparator
    Placebo

    Drug: HS-10374-matched placebo tablets

Interventions

  • DrugHS-10374 6mg tablets

    Administered orally QD for 12 weeks

  • DrugHS-10374-matched placebo tablets

    Administered orally QD for 12 weeks

06

What researchers measure

Primary outcomes

  1. Proportion of patients achieving sPGA 0/1 with at least 2 points improvement from baseline at Week 12

    Static physician's global assessment (sPGA) of psoriasis is an average assessment of all psoriatic lesions based on erythema, induration, and scale. It's a 5-point scale performed by investigators. A sPGA score of 0 or 1 means "clear" or "almost clear" respectively.

    Time frame: Baseline to Week 12

Secondary outcomes

  1. Incidence, severity and association with the study drug of adverse events (AEs), serious AEs (SAEs), and AEs leading to discontinuation

    Time frame: Baseline to Week 16

  2. Number of participants with clinical laboratory abnormalities

    Clinical laboratory tests include hematology, coagulation testing, blood chemistry, urinalysis, stool analysis, C-reactive protein, etc.

    Time frame: Baseline to Week 16

  3. Incidence of clinically significant changes in electrocardiogram (ECG)

    ECG parameters include heart rate, PR interval, RR interval, QRS duration, QTcF interval.

    Time frame: Baseline to Week 16

  4. Number of participants with abnormalities of physical examination

    Physical examination includes assessments of general appearance, skin, lymph nodes, head, neck, lung, heart, abdomen, spine, extremities, nervous system, etc.

    Time frame: Baseline to Week 16

  5. Number of participants with abnormalities of vital signs

    Vital signs measured include blood pressure, pulse rate, and temperature.

    Time frame: Baseline to Week 16

  6. Proportion of patients with sPGA 0/1 at specified time points

    Static physician's global assessment (sPGA) of psoriasis is an average assessment of all psoriatic lesions based on erythema, induration, and scale. It's a 5-point scale performed by investigators. A sPGA score of 0 or 1 means "clear" or "almost clear" respectively.

    Time frame: Baseline to Week 16

  7. Proportion of patients achieving BSA 75 response at specified time points

    Psoriasis body surface area (BSA) involvement is measured using the handprint method with the size of a patient's handprint representing \~1% of body surface area involved. BSA 75 response is defined as 75% or greater improvement in BSA score from baseline.

    Time frame: Baseline to Week 16

  8. Change from baseline in BSA at specified time points

    Psoriasis body surface area (BSA) involvement is measured using the handprint method with the size of a patient's handprint representing \~1% of body surface area involved.

    Time frame: Baseline to Week 16

  9. Proportion of patients who achieved BSA ≤ 1% at specified time points

    Psoriasis body surface area (BSA) involvement is measured using the handprint method with the size of a patient's handprint representing \~1% of body surface area involved.

    Time frame: Baseline to Week 16

  10. Change from baseline in PASI at specified time points

    Psoriasis Area and Severity Index (PASI) is a scoring system quantifying the severity of psoriasis based on both lesion severity and area of involvement. PASI assessment is performed by investigators, and the numeric score ranges from 0 to 72, with higher PASI scores denoting more severe disease activity.

    Time frame: Baseline to Week 16

  11. Proportion of patients who achieved BSA ≤ 3% for patients with baseline BSA > 3% at specified time points

    Psoriasis body surface area (BSA) involvement is measured using the handprint method with the size of a patient's handprint representing \~1% of body surface area involved.

    Time frame: Baseline to Week 16

  12. Proportion of patients achieving ss-PGA 0/1 for patients with a baseline ss-PGA score ≥2 at specified time points

    Scalp specific physician's global assessment (sPGA) of psoriasis is an assessment of the disease severity of scalp psoriasis based on erythema, thickness, and scale. It's a 5-point scale performed by investigators. A sPGA score of 0 or 1 means "absence of disease" or "very mild disease" respectively.

    Time frame: Baseline to Week 16

  13. Change from baseline in DLQI scores at specified time points

    The dermatology life quality index (DLQI) is a patient reported outcome measurement. It's a questionnaire consisting of 10 questions concerning patients' perception of the impact of skin diseases on different aspects of their health-related quality of life over the last week. Each question is scored on a scale of 0 to 3, and the sum of each scores range from 0 (no impairment of life quality) to 30 (maximum impairment).

    Time frame: Baseline to Week 16

07

Study locations

1 site
  • Shanghai Dermatology Hospital
    Shanghai, Shanghai Municipality 200443, China
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Apr 2025; primary completion for Jul 2026, 15 months later.

Of 135 industry-sponsored phase 2 interventional studies under Psoriasis, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 20. This study's planned 15 months is above that.

Counting every sponsor, half of 160 studies reached it within 13 months; a quarter within 9 and three quarters within 23.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 10, 2025
First posted
Apr 13, 2025
StartEst.
Apr 9, 2025
Primary completionEst.
Jul 9, 2026
CompletionEst.
Dec 9, 2026
Last update
Apr 13, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 13, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06926582
Lead sponsor
Hansoh BioMedical R&D Company
Responsible party
Sponsor
First posted
Apr 13, 2025
Start date
Apr 9, 2025 (estimated)
Primary completion
Jul 9, 2026 (estimated)
Completion
Dec 9, 2026 (estimated)
Last update
Apr 13, 2025

Study contacts

Yuling Shi, MD
Contact
shiyuling1973@126.com
(0086)021-61833000
Yuling Shi, MD
principal investigator · Shanghai Dermatology Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is not yet recruiting, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.

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