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Not yet recruitingNCT06943950Updated Apr 30, 2025

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

A Phase 3 interventional study of SYHX1901 in Moderate to Severe Plaque Psoriasis, sponsored by CSPC Ouyi Pharmaceutical Co., Ltd.. Not yet recruiting. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-04-30.

Sponsored by CSPC Ouyi Pharmaceutical Co., Ltd. (part of CSPC Pharmaceutical Group Limited) · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
500
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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.

Read the detailed description

This is a multicenter, randomized, double-blind, placebo-controlled phase III study to evaluate the efficacy and safety of three different doses of SYHX1901 tablets compared with placebo in the treatment of moderate to severe plaque psoriasis. The total duration of the study will be 60 weeks which will be comprised of: a screening period (4 weeks); a core treatment period (16 weeks), a extended treatment period(36 weeks)and a follow-up assessment period (4 weeks). Eligible subjects will be randomly assigned to SYHX1901 dose 1 , dose 2 or placebo group at a 2:2:1 ratio for continuous oral administration for 16 weeks,then placebo group will will be randomly assigned to SYHX1901 dose 1, dose 2 at a 1:1 ratio for continuous oral administration for 36 weeks, the SYHX1901 dose 1, dose 2 group will remain the same dose for 36 weeks. The presence or absence of prior treatment with biological agents will be a stratification factor. Subjects will be monitored for the efficacy and safety throughout the study.

02

Conditions studied

  • Moderate to Severe Plaque Psoriasis

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03

In context

Psoriasis

2,028 studies on the registry are indexed under Psoriasis; 275 are open to participants now.

This study's planned enrollment of 500 is above the median of 75 across 1,565 interventional studies indexed under Psoriasis.

Browse Psoriasis studies →

Lead sponsor

CSPC Ouyi Pharmaceutical Co., Ltd. is the lead sponsor of 30 studies on the registry; 15 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years to 65 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

Subjects fully understand and voluntarily participate in this study and sign ; 2. Age ≥18 and ≤ 65 years old; 3. Subjects with a clinical diagnosis of stable moderate-to-severe plaque psoriasis with a history ≥6 months before randomization; Subjects with stable moderate-to-severe plaque psoriasis defined as meeting all four of the following criteria simultaneously:

  1. Subject must be diagnosed of chronic plaque psoriasis with no morphological changes or significant outbreaks of disease activity assessed by the investigator;
  2. Subject must be a candidate for systemic treatment or phototherapy assessed by the investigator;
  3. Body Surface Area (BSA) affected by plaque-type psoriasis ≥10% at screening and baseline;
  4. 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 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.

Exclusion criteria

Exclusion Criteria:

  1. Forms of psoriasis other than plaque psoriasis (Guttate psoriasis、erythrodermic psoriasis、Pustular psoriasis、Drug-induced psoriasis);
  2. Previous or current disease that may affect the clinical evaluation of psoriasis;
  3. Other active skin conditions that may affect the clinical evaluation of psoriasis;
  4. Active bacterial, viral, fungal, or other infection that requires medical intervention;
  5. With progressive or uncontrolled systemic disease, or with chronic disease identified by the investigator as inappropriate for participation in the study;
  6. History of ;
  7. Any other medical and/or social reasons identified by the investigator as inappropriate for participation in the study;
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
500 participants (estimated)

Study arms

  • Experimental
    SYHX1901 dose 1

    Drug: SYHX1901

  • Experimental
    SYHX1901 dose 2

    Drug: SYHX1901

  • Placebo comparator
    Placebo

    Drug: SYHX1901

Interventions

  • Administered orally, once daily (QD)

06

What researchers measure

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

07

Study locations

No study locations are listed for this record.

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 Jun 2025; primary completion for Apr 2027, 22 months later.

Of 217 industry-sponsored phase 3 interventional studies under Psoriasis, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 26. This study's planned 22 months is above that.

Counting every sponsor, half of 227 studies reached it within 15 months; a quarter within 10 and three quarters within 26.

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

Registered
Apr 17, 2025
First posted
Apr 25, 2025
StartEst.
Jun 1, 2025
Primary completionEst.
Apr 28, 2027
CompletionEst.
Jun 30, 2027
Last update
Apr 30, 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 30, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06943950
Responsible party
Sponsor
First posted
Apr 25, 2025
Start date
Jun 1, 2025 (estimated)
Primary completion
Apr 28, 2027 (estimated)
Completion
Jun 30, 2027 (estimated)
Last update
Apr 30, 2025

Study contacts

Clinical Trials Information Group officer
Contact
ctr-contact@cspc.cn
86-0311-69085587

Oversight

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

Not currently enrolling

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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Discussion

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Studies of the drug tested here: SYHX1901

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