Moderate-to-Severe Plaque PsoriasisPhase 2PSONCT04612699
A Phase 2 Study of Jaktinib in Participants With Moderate to Severe Psoriasis
A Phase 2 study testing Jaktinib in people with Moderate-to-Severe Plaque Psoriasis, run by Suzhou Zelgen Biopharmaceuticals Co.,Ltd at 1 site in China.
Trial summary
This is study designed to investigate the efficacy and safety of Jaktinib in the treatment of participants with moderate to severe, chronic plaque psoriasis as assessed by the Psoriasis Area and Severity Index (PASI) score and routine safety assessments. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Moderate-to-Severe Plaque Psoriasis
- What is being tested?
- Jaktinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 123 participants
- Where
- 1 siteChina
- Study dates
- 11 Mar 2021to 15 Aug 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18~65 years old (including lower limit), no gender limit；
- You must have active chronic plaque psoriasis for at least 6 months prior to entry into the study；
- You must have active plaque psoriasis covering at least 10% body surface area； You must have Psoriasis Area and Severity Index (PASI) score of at least 12；You must have Static Physician's Global Assessment (sPGA) score of at least 3；
- The patient can communicate well with the investigator and follow the research and follow-up procedures；
- Understand and voluntarily sign the informed consent form.
Who cannot join
- You must not have prior treatment with an oral Janus kinase (JAK) inhibitor；
- You must not have received a phototherapy within 4 weeks prior to entry into the study；
- You must not have a history of active hepatitis B, hepatitis C, or human immunodeficiency virus (HIV)；
- You must not have a history of chronic alcohol abuse or intravenous (IV) drug abuse
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of China Medical University
Shenyang, Liaoning, 110000
About this study
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of Jaktinib in Patients With Moderate-to-Severe Plaque Psoriasis
This is study designed to investigate the efficacy and safety of Jaktinib in the treatment of participants with moderate to severe, chronic plaque psoriasis as assessed by the Psoriasis Area and Severity Index (PASI) score and routine safety assessments.
- Conditions
- Moderate-to-Severe Plaque Psoriasis
- Being tested
- Jaktinib, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JaktinibDrug
Administered orally
PlaceboDrug
Administered orally
| Study group | Role | What they receive |
|---|---|---|
| Jaktinib 50mg Bid | Experimental | Jaktinib 50mg Bid+ Placebo 50mg Bid+ Placebo 75mg Bid Receives: Drug: Jaktinib; Drug: Placebo |
| Jaktinib 75mg Bid | Experimental | Jaktinib 75mg Bid+ Placebo 50mg*2 Bid Receives: Drug: Jaktinib; Drug: Placebo |
| Jaktinib 100mg Bid | Experimental | Jaktinib 50mg*2 Bid+ Placebo 75mg Bid Receives: Drug: Jaktinib; Drug: Placebo |
| Placebo | Placebo comparator | Placebo 50mg*2 Bid+ Placebo 75mg Bid Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Achieving Psoriasis Area and Severity Index Score ≥75% (PASI 75) Improvement (Efficacy of Jaktinib in Participants With Moderate to Severe Plaque Psoriasis. Measure: Psoriasis Area and Severity Index [PASI])
The PASI combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of desquamation (scaling), erythema (redness), and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no psoriasis to 72 for the most severe disease.
Measured: Week 12
Secondary outcomes (1)
Percentage of Participants Achieving a Static Physician Global Assessment (sPGA) of (0, 1) (Efficacy of Jaktinib in Participants With Moderate to Severe Plaque Psoriasis. Measure: Static Physician Global Assessment [sPGA])
The sPGA is a physician's determination of the participant's psoriasis lesions overall at a given time point categorized by descriptions for induration, erythema, and scaling. For the analysis of responses, the participant's psoriasis is assessed as clear
Measured: Week 8、12、16、20、24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2020
- Study start11 Mar 2021
- Primary completion15 Aug 2022
- Study completion15 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Moderate-to-Severe Plaque PsoriasisStudies of the same condition, open and under way.
- More trials run by Suzhou Zelgen Biopharmaceuticals Co.,LtdThe 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suzhou Zelgen Biopharmaceuticals Co.,Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Xinghua Gao, PhD, Principal investigator, First Hospital of China Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04612699
- Sponsor's protocol ID
- ZGJAK010
- Acronym
- PSO
- Status last verified
- Feb 2025
- First submitted
- 29 Oct 2020
- Last updated
- 20 Feb 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 20 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of Jaktinib in Patients With Moderate-to-Severe Plaque Psoriasis
- ClinicalTrials.gov ID
- NCT04612699
- Acronym / sponsor ID
- PSO / ZGJAK010
- Conditions
- Moderate-to-Severe Plaque Psoriasis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- Suzhou Zelgen Biopharmaceuticals Co.,LtdIndustry (pharma, biotech, devices)
- Study start
- 11 Mar 2021 (actual)
- Primary completion
- 15 Aug 2022 (actual)
- Study completion
- 15 Aug 2022 (actual)
- First posted
- 3 Nov 2020 (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.
This is study designed to investigate the efficacy and safety of Jaktinib in the treatment of participants with moderate to severe, chronic plaque psoriasis as assessed by the Psoriasis Area and Severity Index (PASI) score and routine safety assessments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Jaktinib 50mg Bid | Experimental | Drug: Jaktinib, Drug: PlaceboJaktinib 50mg Bid+ Placebo 50mg Bid+ Placebo 75mg Bid |
| Jaktinib 75mg Bid | Experimental | Drug: Jaktinib, Drug: PlaceboJaktinib 75mg Bid+ Placebo 50mg*2 Bid |
| Jaktinib 100mg Bid | Experimental | Drug: Jaktinib, Drug: PlaceboJaktinib 50mg*2 Bid+ Placebo 75mg Bid |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo 50mg*2 Bid+ Placebo 75mg Bid |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18~65 years old (including lower limit), no gender limit；
- You must have active chronic plaque psoriasis for at least 6 months prior to entry into the study；
- You must have active plaque psoriasis covering at least 10% body surface area； You must have Psoriasis Area and Severity Index (PASI) score of at least 12；You must have Static Physician's Global Assessment (sPGA) score of at least 3；
- The patient can communicate well with the investigator and follow the research and follow-up procedures；
- Understand and voluntarily sign the informed consent form.
Key exclusion criteria (4 listed)
- You must not have prior treatment with an oral Janus kinase (JAK) inhibitor；
- You must not have received a phototherapy within 4 weeks prior to entry into the study；
- You must not have a history of active hepatitis B, hepatitis C, or human immunodeficiency virus (HIV)；
- You must not have a history of chronic alcohol abuse or intravenous (IV) drug abuse
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 |
|---|---|---|
| JaktinibAdministered orally | Drug | Jaktinib 100mg Bid, Jaktinib 50mg Bid, Jaktinib 75mg Bid |
| PlaceboAdministered orally | Drug | Jaktinib 100mg Bid, Jaktinib 50mg Bid, Jaktinib 75mg Bid, Placebo |
Primary outcome
Percentage of Participants Achieving Psoriasis Area and Severity Index Score ≥75% (PASI 75) Improvement (Efficacy of Jaktinib in Participants With Moderate to Severe Plaque Psoriasis. Measure: Psoriasis Area and Severity Index [PASI])
Time frame: Week 12
The PASI combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of desquamation (scaling), erythema (redness), and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no psoriasis to 72 for the most severe disease.
1 secondary outcome
Percentage of Participants Achieving a Static Physician Global Assessment (sPGA) of (0, 1) (Efficacy of Jaktinib in Participants With Moderate to Severe Plaque Psoriasis. Measure: Static Physician Global Assessment [sPGA])
Time frame: Week 8、12、16、20、24
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 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. This study is not recruiting at the moment.
Xinghua Gao, PhD principal investigator
First Hospital of China Medical University
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 Jaktinib in people with Moderate-to-Severe Plaque Psoriasis, run by Suzhou Zelgen Biopharmaceuticals 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 4 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: finished, as of the sponsor's last update on 20 Feb 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Achieving Psoriasis Area and Severity Index Score ≥75% (PASI 75) Improvement (Efficacy of Jaktinib in Participants With Moderate to Severe Plaque Psoriasis. Measure: Psoriasis Area and Severity Index [PASI]) (time frame: Week 12). 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 20 Feb 2025.