PsoriasisPhase 2NCT07150988
A Phase II Efficacy and Safety Study of HSK44459 in Subjects With Moderate to Severe Plaque Psoriasis
A Phase 2 study testing HSK44459 dose level 1 and HSK44459 dose level 2 in people with Psoriasis, run by Haisco Pharmaceutical Group Co., Ltd. at 1 site in China.
Trial summary
The purpose of this study is to assess the efficacy and safety of HSK44459 administered orally for moderate to severe plaque psoriasis in adults. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis
- What is being tested?
- HSK44459 dose level 1 and HSK44459 dose level 2
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 26 Sep 2025to 6 Nov 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Fully understand and voluntarily participate this trial, and sign the informed consent form;
- Age≥18 years, regardless of gender;
- Plaque psoriasis;
- A candidate for systemic therapy;
- Agree to use a highly effective method(s) of from the signing of the informed consent form to 3 months post-treatment.
Who cannot join
- Can not discontinue the prohibited medications specified in the protocol before the first dose and throughout the entire study period;
- Laboratory abnormalities with clinical significance;
- Forms of psoriasis other than chronic plaque-type;
- Presence of other dermatological or autoimmune diseases;
- Presence of active infection requiring systemic therapy;
- Has undergone or plans to undergo major surgery;
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- History of cardiovascular or cerebrovascular diseases;
- History of suicide attempts or major psychiatric disorders;
- History of malignant tumors;
- History of gastrointestinal surgery or diseases that may have impact on the study;
- History of drug abuse, illicit drug use, or alcohol abuse;
- History of severe drug allergies;
- Pregnant or lactating women;
- Subjects with any other factor considered by the investigator to be ineligible for participation in the trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Hangzhou First People's Hospital
Hangzhou, Zhejiang
Liming Wu, 13750837205, 18957118053@163.com
About this study
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of HSK44459 in Subjects With Moderate to Severe Plaque Psoriasis
The purpose of this study is to assess the efficacy and safety of HSK44459 administered orally for moderate to severe plaque psoriasis in adults.
Read the detailed description
Patients with moderate to severe plaque psoriasis will be randomized into 3 cohorts (dose level 1, dose level 2 and placebo). Approximately 150 subjects will be enrolled. This study includes an 16-week treatment Period, then a 4-week safety visit period.
- Conditions
- Psoriasis
- Being tested
- HSK44459 dose level 1, HSK44459 dose level 2, placebo
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HSK44459 dose level 1Drug
HSK44459 dose level 1 oral administration
HSK44459 dose level 2Drug
HSK44459 dose level 2 orally administration
placeboDrug
placebo oral adminisitration
| Study group | Role | What they receive |
|---|---|---|
| HSK44459 dose level 1 | Experimental | HSK44459 dosage 1 oral administration Receives: Drug: HSK44459 dose level 1 |
| HSK44459 dose level 2 | Experimental | HSK44459 dose level 2 oral administration Receives: Drug: HSK44459 dose level 2 |
| Placebo control | Placebo comparator | placebo oral administration Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects who have ≥75% reduction in PASI (PASI-75).
The proportion of subjects who have a reduction of 75% or more from baseline in the psoriasis area-and-severity index score (PASI 75) at week 16.
Measured: 16 weeks
Secondary outcomes (4)
Proportion of subjects achieving an IGA score of clear 0 or 1 with ≥2 point reduction from baseline.
Proportion of subjects achieving an IGA score of clear 0 or 1 with ≥2 point reduction at week 2, 4, 8, 12 and 16 from baseline.
Measured: 2, 4, 8, 12 and 16 weeks
Proportion of subjects who have ≥75% reduction in PASI (PASI-75).
The proportion of subjects who have a reduction of 75% or more from baseline in the psoriasis area-and-severity index score (PASI 75) at week 2, 4, 8 and 12.
Measured: 2, 4, 8 and 12 weeks
Proportion of subjects who have ≥50% reduction in PASI (PASI-50).
The proportion of subjects who have a reduction of 50% or more from baseline in the psoriasis area-and-severity index score (PASI-50 at week 2, 4, 8, 12 and 16.
Measured: 2, 4, 8, 12 and 16 weeks
Proportion of subjects who have ≥90% reduction in PASI (PASI-90).
The proportion of subjects who have a reduction of 90% or more from baseline in the psoriasis area-and-severity index score (PASI-90) at week 2, 4, 8, 12 and 16.
Measured: 2, 4, 8, 12 and 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2025
- Study start26 Sep 2025 (estimated)
- Primary completion6 Nov 2026 (estimated)
- Study completion6 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- More trials run by Haisco Pharmaceutical Group Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Haisco Pharmaceutical Group Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07150988
- Sponsor's protocol ID
- HSK44459-206
- Status last verified
- Aug 2025
- First submitted
- 27 Aug 2025
- Last updated
- 2 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of HSK44459 in Subjects With Moderate to Severe Plaque Psoriasis
- ClinicalTrials.gov ID
- NCT07150988
- Acronym / sponsor ID
- HSK44459-206
- Conditions
- Psoriasis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Haisco Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 26 Sep 2025 (estimated)
- Primary completion
- 6 Nov 2026 (estimated)
- Study completion
- 6 Nov 2026 (estimated)
- First posted
- 2 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the efficacy and safety of HSK44459 administered orally for moderate to severe plaque psoriasis in adults.
Detailed description
Patients with moderate to severe plaque psoriasis will be randomized into 3 cohorts (dose level 1, dose level 2 and placebo). Approximately 150 subjects will be enrolled. This study includes an 16-week treatment Period, then a 4-week safety visit period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HSK44459 dose level 1 | Experimental | Drug: HSK44459 dose level 1HSK44459 dosage 1 oral administration |
| HSK44459 dose level 2 | Experimental | Drug: HSK44459 dose level 2HSK44459 dose level 2 oral administration |
| Placebo control | Placebo comparator | Drug: placeboplacebo oral administration |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Fully understand and voluntarily participate this trial, and sign the informed consent form;
- Age≥18 years, regardless of gender;
- Plaque psoriasis;
- A candidate for systemic therapy;
- Agree to use a highly effective method(s) of from the signing of the informed consent form to 3 months post-treatment.
Key exclusion criteria (14 listed)
- Can not discontinue the prohibited medications specified in the protocol before the first dose and throughout the entire study period;
- Laboratory abnormalities with clinical significance;
- Forms of psoriasis other than chronic plaque-type;
- Presence of other dermatological or autoimmune diseases;
- Presence of active infection requiring systemic therapy;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HSK44459 dose level 1HSK44459 dose level 1 oral administration | Drug | HSK44459 dose level 1 |
| HSK44459 dose level 2HSK44459 dose level 2 orally administration | Drug | HSK44459 dose level 2 |
| placeboplacebo oral adminisitration | Drug | Placebo control |
Primary outcome
Proportion of subjects who have ≥75% reduction in PASI (PASI-75).
Time frame: 16 weeks
The proportion of subjects who have a reduction of 75% or more from baseline in the psoriasis area-and-severity index score (PASI 75) at week 16.
4 secondary outcomes
Proportion of subjects achieving an IGA score of clear 0 or 1 with ≥2 point reduction from baseline.
Time frame: 2, 4, 8, 12 and 16 weeks
Proportion of subjects who have ≥75% reduction in PASI (PASI-75).
Time frame: 2, 4, 8 and 12 weeks
Proportion of subjects who have ≥50% reduction in PASI (PASI-50).
Time frame: 2, 4, 8, 12 and 16 weeks
Proportion of subjects who have ≥90% reduction in PASI (PASI-90).
Time frame: 2, 4, 8, 12 and 16 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HSK44459 dose level 1 and HSK44459 dose level 2 in people with Psoriasis, run by Haisco Pharmaceutical Group Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yong Cao (028-67258779, caoyong@haisco.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of subjects who have ≥75% reduction in PASI (PASI-75). (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2025.