Plaque PsoriasisPhase 3NCT07326813
A Clinical Study to Evaluate the Efficacy and Safety of D-2570 in the Treatment of Moderate to Severe Plaque Psoriasis
A Phase 3 study testing D-2570 Tablet and BMS-986165 Tablet in people with Plaque Psoriasis, run by InventisBio Co., Ltd at 1 site in China.
Trial summary
This study is a randomized, double-blind, placebo- and active-controlled multicenter clinical trial involving patients with moderate to severe plaque psoriasis. Safety and efficacy assessments will be conducted during the scheduled study visits throughout the trial. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Plaque Psoriasis
- What is being tested?
- D-2570 Tablet and BMS-986165 Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 477 participants
- Where
- 1 siteChina
- Study dates
- 12 Jan 2026to 3 Dec 2027
- Phase
- Phase 3
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient voluntarily participates in this study after providing fully informed consent, signs a written informed consent form, and agrees to comply with the procedures specified in the study protocol;
- Aged between 18 and 70 years old (inclusive) at the time of signing the informed consent form, regardless of gender;
- The investigator assesses that the subject has plaque psoriasis suitable for systemic therapy, and the condition has been stable for ≥ 6 months before signing the informed consent form;
- At the screening stage and Day 1 (D1) of the treatment period, the Psoriasis Body Surface Area (BSA) is ≥10%, the Physician Global Assessment (PGA) score is ≥ 3 points, and the Psoriasis Area and Severity Index (PASI) score is ≥ 12 points;
- Hematology, Blood chemistry and Urinalysis examination were basically normal;
- Male subjects and female subjects of childbearing potential must agree to abstain from sexual intercourse or adopt effective contraceptive measures from the time of signing the informed consent form (ICF) until 30 days after the last administration of the investigational product.
Who cannot join
- Suffering from any type of psoriasis including erythrodermic psoriasis, pustular psoriasis, guttate psoriasis, inverse psoriasis, or drug-induced psoriasis;
- Having other skin lesions that may interfere with the assessment of treatment outcomes, such as eczema;
- A history of severe herpes zoster/simplex infection;
- A history of tuberculosis, active tuberculosis, latent tuberculosis, or clinical manifestations suggestive of tuberculosis infection
- Having language barriers, or being unwilling or unable to fully understand and cooperate;
- Being pregnant or lactating women;
- Other circumstances that the investigator deems unsuitable for the subject to participate in the study.
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, 1 recruiting
- Recruiting
Shanghai Skin Disease Hospital
Shanghai, Shanghai Municipality, 200443
Yuling Shi, +86 021-36803000, shiyuling1973@126.com
About this study
Official title: A Multicenter, Randomized, Double-Blind, Placebo-and Active-Controlled Clinical Study to Evaluate the Efficacy and Safety of D-2570 in the Treatment of Moderate to Severe Plaque Psoriasis
This study is a randomized, double-blind, placebo- and active-controlled multicenter clinical trial involving patients with moderate to severe plaque psoriasis.
Safety and efficacy assessments will be conducted during the scheduled study visits throughout the trial. After completing the respective treatment, all subjects will undergo a safety follow-up. Both the investigators and subjects will remain blinded throughout the entire treatment period.
During the study, subjects are required to provide blood samples for pharmacokinetic (PK) and pharmacodynamic (PD) analyses at the time points specified in the trial protocol.
- Conditions
- Plaque Psoriasis
- Being tested
- D-2570 Tablet, BMS-986165 Tablet, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
D-2570 TabletDrug
D-2570 is a novel inhibitor targeting the TYK2 pseudokinase domain
BMS-986165 TabletDrug
BMS-986165 is a novel inhibitor targeting TYK2
PlaceboDrug
A placebo refers to a tablet that has no therapeutic effect on medication
| Study group | Role | What they receive |
|---|---|---|
| Evaluate the efficacy of different doses of D-2570 compared with placebo | Experimental | Not described Receives: Drug: D-2570 Tablet; Drug: Placebo |
| Evaluate the efficacy of different doses of D-2570 compared with BMS-98165 | Active comparator | Not described Receives: Drug: D-2570 Tablet; Drug: BMS-986165 Tablet |
| Evaluate the safety of D-2570 treatment at different dosages | Experimental | Not described Receives: Drug: D-2570 Tablet |
| Evaluate the pharmacokinetics and pharmacodynamics of D-2570 in patients with plaque psoriasis | Experimental | Not described Receives: Drug: D-2570 Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the efficacy of different doses of D-2570 compared with placebo in the treatment of patients with moderate to severe plaque psoriasis
Psoriasis Area and Severity Index (PASI)
Measured: Treatment for 16 weeks after enrollment
To evaluate the efficacy of different doses of D-2570 compared with placebo in the treatment of patients with moderate to severe plaque psoriasis
Physician Global Assessment (PGA)
Measured: Treatment for 16 weeks after enrollment
To evaluate the efficacy of different doses of D-2570 compared with placebo in the treatment of patients with moderate to severe plaque psoriasis
Dermatology Life Quality Index (DLQI)
Measured: Treatment for 16 weeks after enrollment
Secondary outcomes (12)
To evaluate the efficacy of different doses of D-2570 compared with BMS-986165 in the treatment of patients with moderate to severe plaque psoriasis
Psoriasis Area and Severity Index (PASI)
Measured: Treatment for 16 weeks after enrollment
To evaluate the efficacy of different doses of D-2570 compared with BMS-986165 in the treatment of patients with moderate to severe plaque psoriasis
Physician Global Assessment (PGA)
Measured: Treatment for 16 weeks after enrollment
To evaluate the efficacy of different doses of D-2570 compared with BMS-986165 in the treatment of patients with moderate to severe plaque psoriasis
Dermatology Life Quality Index (DLQI)
Measured: Treatment for 16 weeks after enrollment
To evaluate the safety of different doses of D-2570 in the treatment of patients with moderate to severe plaque psoriasis
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Measured: Through study completion, an average of 28 weeks
To evaluate the safety of different doses of D-2570 in the treatment of patients with moderate to severe plaque psoriasis
Vital signs: blood pressure
Measured: Through study completion, an average of 28 weeks
To evaluate the safety of different doses of D-2570 in the treatment of patients with moderate to severe plaque psoriasis
Vital signs: body temperature
Measured: Through study completion, an average of 28 weeks
To evaluate the safety of different doses of D-2570 in the treatment of patients with moderate to severe plaque psoriasis
Vital signs: heart rate
Measured: Through study completion, an average of 28 weeks
To evaluate the safety of different doses of D-2570 in the treatment of patients with moderate to severe plaque psoriasis
Vital signs: respiration
Measured: Through study completion, an average of 28 weeks
To evaluate the physical examination of different doses of D-2570 in the treatment of patients with moderate to severe plaque psoriasis
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Measured: Through study completion, an average of 28 weeks
To evaluate the safety of different doses of D-2570 in the treatment of patients with moderate to severe plaque psoriasis
12-lead electrocardiogram (ECG) examination: QT Interval
Measured: Through study completion, an average of 28 weeks
To evaluate the safety of different doses of D-2570 in the treatment of patients with moderate to severe plaque psoriasis
12-lead electrocardiogram (ECG) examination: Heart rate
Measured: Through study completion, an average of 28 weeks
To evaluate the pharmacokinetic characteristics (PK) of different doses of D-2570 in the treatment of patients with moderate to severe plaque psoriasis
Blood drug concentration
Measured: Day1, Day15, Day29, Day57, Day85, Day113
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2026
- Study start12 Jan 2026
- Primary completion12 Jul 2027 (estimated)
- Study completion3 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plaque PsoriasisStudies of the same condition, open and under way.
- More trials run by InventisBio 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 477 participants (estimated)
Sponsor and investigators
- Lead sponsor
- InventisBio Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07326813
- Sponsor's protocol ID
- D2570-302
- Status last verified
- Apr 2026
- First submitted
- 12 Dec 2025
- Last updated
- 29 Apr 2026
- 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 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Placebo-and Active-Controlled Clinical Study to Evaluate the Efficacy and Safety of D-2570 in the Treatment of Moderate to Severe Plaque Psoriasis
- ClinicalTrials.gov ID
- NCT07326813
- Acronym / sponsor ID
- D2570-302
- Conditions
- Plaque Psoriasis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 477 participants (estimated)
- Lead sponsor
- InventisBio Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 12 Jan 2026 (actual)
- Primary completion
- 12 Jul 2027 (estimated)
- Study completion
- 3 Dec 2027 (estimated)
- First posted
- 8 Jan 2026 (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 study is a randomized, double-blind, placebo- and active-controlled multicenter clinical trial involving patients with moderate to severe plaque psoriasis.
Safety and efficacy assessments will be conducted during the scheduled study visits throughout the trial. After completing the respective treatment, all subjects will undergo a safety follow-up. Both the investigators and subjects will remain blinded throughout the entire treatment period.
During the study, subjects are required to provide blood samples for pharmacokinetic (PK) and pharmacodynamic (PD) analyses at the time points specified in the trial protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Evaluate the efficacy of different doses of D-2570 compared with placebo | Experimental | Drug: D-2570 Tablet, Drug: Placebo |
| Evaluate the efficacy of different doses of D-2570 compared with BMS-98165 | Active comparator | Drug: D-2570 Tablet, Drug: BMS-986165 Tablet |
| Evaluate the safety of D-2570 treatment at different dosages | Experimental | Drug: D-2570 Tablet |
| Evaluate the pharmacokinetics and pharmacodynamics of D-2570 in patients with plaque psoriasis | Experimental | Drug: D-2570 Tablet |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- The patient voluntarily participates in this study after providing fully informed consent, signs a written informed consent form, and agrees to comply with the procedures specified in the study protocol;
- Aged between 18 and 70 years old (inclusive) at the time of signing the informed consent form, regardless of gender;
- The investigator assesses that the subject has plaque psoriasis suitable for systemic therapy, and the condition has been stable for ≥ 6 months before signing the informed consent form;
- At the screening stage and Day 1 (D1) of the treatment period, the Psoriasis Body Surface Area (BSA) is ≥10%, the Physician Global Assessment (PGA) score is ≥ 3 points, and the Psoriasis Area and Severity Index (PASI) score is ≥ 12 points;
- Hematology, Blood chemistry and Urinalysis examination were basically normal;
Key exclusion criteria (7 listed)
- Suffering from any type of psoriasis including erythrodermic psoriasis, pustular psoriasis, guttate psoriasis, inverse psoriasis, or drug-induced psoriasis;
- Having other skin lesions that may interfere with the assessment of treatment outcomes, such as eczema;
- A history of severe herpes zoster/simplex infection;
- A history of tuberculosis, active tuberculosis, latent tuberculosis, or clinical manifestations suggestive of tuberculosis infection
- Having language barriers, or being unwilling or unable to fully understand and cooperate;
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 |
|---|---|---|
| D-2570 TabletD-2570 is a novel inhibitor targeting the TYK2 pseudokinase domain | Drug | Evaluate the efficacy of different doses of D-2570 compared with BMS-98165, Evaluate the efficacy of different doses of D-2570 compared with placebo, Evaluate the pharmacokinetics and pharmacodynamics of D-2570 in patients with plaque psoriasis, Evaluate the safety of D-2570 treatment at different dosages |
| BMS-986165 TabletBMS-986165 is a novel inhibitor targeting TYK2 | Drug | Evaluate the efficacy of different doses of D-2570 compared with BMS-98165 |
| PlaceboA placebo refers to a tablet that has no therapeutic effect on medication | Drug | Evaluate the efficacy of different doses of D-2570 compared with placebo |
Primary outcome
To evaluate the efficacy of different doses of D-2570 compared with placebo in the treatment of patients with moderate to severe plaque psoriasis
Time frame: Treatment for 16 weeks after enrollment
Psoriasis Area and Severity Index (PASI)
To evaluate the efficacy of different doses of D-2570 compared with placebo in the treatment of patients with moderate to severe plaque psoriasis
Time frame: Treatment for 16 weeks after enrollment
Physician Global Assessment (PGA)
To evaluate the efficacy of different doses of D-2570 compared with placebo in the treatment of patients with moderate to severe plaque psoriasis
Time frame: Treatment for 16 weeks after enrollment
Dermatology Life Quality Index (DLQI)
12 secondary outcomes
To evaluate the efficacy of different doses of D-2570 compared with BMS-986165 in the treatment of patients with moderate to severe plaque psoriasis
Time frame: Treatment for 16 weeks after enrollment
To evaluate the efficacy of different doses of D-2570 compared with BMS-986165 in the treatment of patients with moderate to severe plaque psoriasis
Time frame: Treatment for 16 weeks after enrollment
To evaluate the efficacy of different doses of D-2570 compared with BMS-986165 in the treatment of patients with moderate to severe plaque psoriasis
Time frame: Treatment for 16 weeks after enrollment
To evaluate the safety of different doses of D-2570 in the treatment of patients with moderate to severe plaque psoriasis
Time frame: Through study completion, an average of 28 weeks
To evaluate the safety of different doses of D-2570 in the treatment of patients with moderate to severe plaque psoriasis
Time frame: Through study completion, an average of 28 weeks
To evaluate the safety of different doses of D-2570 in the treatment of patients with moderate to severe plaque psoriasis
Time frame: Through study completion, an average of 28 weeks
To evaluate the safety of different doses of D-2570 in the treatment of patients with moderate to severe plaque psoriasis
Time frame: Through study completion, an average of 28 weeks
To evaluate the safety of different doses of D-2570 in the treatment of patients with moderate to severe plaque psoriasis
Time frame: Through study completion, an average of 28 weeks
To evaluate the physical examination of different doses of D-2570 in the treatment of patients with moderate to severe plaque psoriasis
Time frame: Through study completion, an average of 28 weeks
To evaluate the safety of different doses of D-2570 in the treatment of patients with moderate to severe plaque psoriasis
Time frame: Through study completion, an average of 28 weeks
To evaluate the safety of different doses of D-2570 in the treatment of patients with moderate to severe plaque psoriasis
Time frame: Through study completion, an average of 28 weeks
To evaluate the pharmacokinetic characteristics (PK) of different doses of D-2570 in the treatment of patients with moderate to severe plaque psoriasis
Time frame: Day1, Day15, Day29, Day57, Day85, Day113
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 29 Apr 2026.
- 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 3 study testing D-2570 Tablet and BMS-986165 Tablet in people with Plaque Psoriasis, run by InventisBio 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 6 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 29 Apr 2026. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Bingxin Xue ((86)21-50663661, bingxin.xue@inventisbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the efficacy of different doses of D-2570 compared with placebo in the treatment of patients with moderate to severe plaque psoriasis (time frame: Treatment for 16 weeks after enrollment). The study lists 3 primary outcomes in all. 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 29 Apr 2026.