Plaque PsoriasisPhase 3NCT07130604
Evaluate the Efficacy and Safety of D-2570 in Subjects With Moderate to Severe Plaque Psoriasis
A Phase 3 study testing D-2570 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-controlled multicenter clinical trial targeting subjects with moderate to severe plaque psoriasis. 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
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 390 participants
- Where
- 1 siteChina
- Study dates
- 18 Sep 2025to 28 Jul 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
- Subject voluntarily takes part in the study after being fully informed,signs a written ICF, and agrees to follow procedures specified in the study protocol;
- Plaque psoriasis assessed by the investigator as suitable for systemic treatment and stable (defined as stable as no significant outbreak of morphological change or disease activity assessed by the investigator) for at least 6 months prior to signing informed consent;
- During the screening period and before taking the investigational drug for the first time, psoriatic surface area (BSA) ≥10%, PGA score ≥ 3, PASI score ≥ 12;
- Hematology, Blood chemistry and Urinalysis examination were basically normal.
Who cannot join
- Erythrodermic psoriasis, pustular psoriasis, guttate psoriasis, reverse psoriasis, drug-induced psoriasis;
- Have other skin lesions that affect the evaluation of treatment outcomes, such as eczema;
- History of herpes zoster/herpes simplex, or presence of herpes zoster/herpes simplex infection during the screening period;
- Have a history of tuberculosis, or active tuberculosis, or latent tuberculosis, or suspected clinical manifestations of tuberculosis infection;
- Other conditions that the investigator considers inappropriate for participation 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
Peking University People's Hospital
Beijing, Beijing Municipality
Jianzhong Zhang, 13911815813, rmzjz@126.com
About this study
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase III Study to Evaluate the Efficacy and Safety of D-2570 in Subjects With Moderate to Severe Plaque Psoriasis
This study is a randomized, double-blind, placebo-controlled multicenter clinical trial targeting subjects with moderate to severe plaque psoriasis.
Read the detailed description
This study is a randomized, double-blind, placebo-controlled multicenter clinical trial targeting subjects with moderate to severe plaque psoriasis, with a total of 390 subjects planned to be enrolled.
- Conditions
- Plaque Psoriasis
- Being tested
- D-2570, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
D-2570Drug
Randomized in a 1:1:1 ratio through the randomization system, and assigned to D-2570 group1, group 2 or placebo group.
PlaceboDrug
Randomized in a 1:1:1 ratio through the randomization system, and assigned to D-2570 group1, group 2 or placebo group.
| Study group | Role | What they receive |
|---|---|---|
| D-2570 group1 | Experimental | Not described Receives: Drug: D-2570 |
| D-2570 group2 | Experimental | Not described Receives: Drug: D-2570 |
| Placebo group | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of subjects with at least 90% improvement in PASI
The percentage of subjects with at least 90% improvement in PASI from baseline at week 16 of treatment.
Measured: Day 1-Day 112
Secondary outcomes (20)
Percentage of subjects with a PGA
Percentage of subjects with a PGA score of 0 or 1 and ≥2 points from baseline at week 16 of treatment.
Measured: Day 1-Day 112
The percentage of subjects with at least 75% improvement in PASI
The percentage of subjects with at least 75% improvement in PASI from baseline at each visit.
Measured: Day1-Day365
The percentage of subjects with at least 90% improvement in PASI
The percentage of subjects with at least 90% improvement in PASI from baseline at each visit.
Measured: Day1-Day365
The percentage of subjects with at least 100% improvement in PASI
The percentage of subjects with at least 100% improvement in PASI from baseline at each visit.
Measured: Day1-Day365
The percentage of subjects with improvement in PASI
The percentage of subjects with improvement in PASI from baseline at each visit.
Measured: Day1-Day365
Percentage of subjects with a PGA
Percentage of subjects with a PGA score of 0 or 1 and ≥2 points from baseline at each visit.
Measured: Day1-Day365
The percentage of subjects with at least 90% improvement in PASI
The percentage of subjects with at least 90% improvement in PASI from baseline at week 16 of treatment and maintained response at Week 52.
Measured: Day1-Day365
Percentage of subjects with a PGA score of 0 or 1 and ≥2 points from baseline
Percentage of subjects with a PGA score of 0 or 1 and ≥2 points from baseline at week 16 of treatment and maintained response at Week 52.
Measured: Day1-Day365
Percentage of subjects with baseline ss-PGA score ≥3
Percentage of subjects with baseline ss-PGA score ≥3 who achieved ss-PGA 0 or 1 at Week 16 of treatment.
Measured: Day 1-Day 112
Percentage of subjects with baseline PGA-F score ≥3
Percentage of subjects with baseline PGA-F score ≥3 who achieved ss-PGA 0 or 1 at Week 16 of treatment.
Measured: Day 1-Day 112
Percentage of subjects with baseline pp-PGA score ≥3
Percentage of subjects with baseline pp-PGA score ≥3 who achieved ss-PGA 0 or 1 at Week 16 of treatment.
Measured: Day 1-Day 112
Percentage of subjects with baseline DLQI score ≥2
Percentage of subjects with baseline DLQI score ≥2 who achieved DLQI 0 or 1 at Week 16 of treatment.
Measured: Day 1-Day 112
The main PK parameters -Time to maximum measured plasma concentration -Tmax Population pharmacokinetic characteristics of D-2570
The main PK parameters -Time to maximum measured plasma concentration -Tmax
Measured: Day1-Day365
The main PK parameters#Area under the plasma concentration versus time curve-AUC
The main PK parameters#Area under the plasma concentration versus time curve-AUC
Measured: Day1-Day365
The main PK parameters-Vz/F (apparent volume of distribution)
The main PK parameters-Vz/F (apparent volume of distribution)
Measured: Day1-Day365
The main PK parameters Half-life -t1/2
The main PK parameters Half-life -t1/2
Measured: Day1-Day365
The main PK parameters-CL/F (apparent clearance)
The main PK parameters-CL/F (apparent clearance)
Measured: Day1-Day365
Weight and height will be combined to report BMI in kg/m^2
Weight and height will be combined to report BMI in kg/m^2
Measured: Day1-Day365
Incidence and severity of AEs based on NCI CTCAE V5.0
Incidence and severity of AEs based on NCI CTCAE V5.0
Measured: Day1-Day365
Incidence and severity of TEAEs based on NCI CTCAE V5.0
Incidence and severity of TEAEs based on NCI CTCAE V5.0
Measured: Day1-Day365
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2025
- Study start18 Sep 2025
- Primary completion28 Jul 2027 (estimated)
- Study completion28 Jul 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 390 participants (estimated)
Sponsor and investigators
- Lead sponsor
- InventisBio Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jianzhong Zhang, Principal investigator, Study Official is required by the WHO and ICMJE.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07130604
- Sponsor's protocol ID
- D2570-301
- Status last verified
- Dec 2025
- First submitted
- 12 Aug 2025
- Last updated
- 9 Dec 2025
- Results posted
- 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 9 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase III Study to Evaluate the Efficacy and Safety of D-2570 in Subjects With Moderate to Severe Plaque Psoriasis
- ClinicalTrials.gov ID
- NCT07130604
- Acronym / sponsor ID
- D2570-301
- Conditions
- Plaque Psoriasis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 390 participants (estimated)
- Lead sponsor
- InventisBio Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 18 Sep 2025 (actual)
- Primary completion
- 28 Jul 2027 (estimated)
- Study completion
- 28 Jul 2027 (estimated)
- First posted
- 19 Aug 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.
This study is a randomized, double-blind, placebo-controlled multicenter clinical trial targeting subjects with moderate to severe plaque psoriasis.
Detailed description
This study is a randomized, double-blind, placebo-controlled multicenter clinical trial targeting subjects with moderate to severe plaque psoriasis, with a total of 390 subjects planned to be enrolled.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| D-2570 group1 | Experimental | Drug: D-2570 |
| D-2570 group2 | Experimental | Drug: D-2570 |
| Placebo group | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subject voluntarily takes part in the study after being fully informed,signs a written ICF, and agrees to follow procedures specified in the study protocol;
- Plaque psoriasis assessed by the investigator as suitable for systemic treatment and stable (defined as stable as no significant outbreak of morphological change or disease activity assessed by the investigator) for at least 6 months prior to signing informed consent;
- During the screening period and before taking the investigational drug for the first time, psoriatic surface area (BSA) ≥10%, PGA score ≥ 3, PASI score ≥ 12;
- Hematology, Blood chemistry and Urinalysis examination were basically normal.
Key exclusion criteria (5 listed)
- Erythrodermic psoriasis, pustular psoriasis, guttate psoriasis, reverse psoriasis, drug-induced psoriasis;
- Have other skin lesions that affect the evaluation of treatment outcomes, such as eczema;
- History of herpes zoster/herpes simplex, or presence of herpes zoster/herpes simplex infection during the screening period;
- Have a history of tuberculosis, or active tuberculosis, or latent tuberculosis, or suspected clinical manifestations of tuberculosis infection;
- Other conditions that the investigator considers inappropriate for participation in the study.
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-2570Randomized in a 1:1:1 ratio through the randomization system, and assigned to D-2570 group1, group 2 or placebo group. | Drug | D-2570 group1, D-2570 group2 |
| PlaceboRandomized in a 1:1:1 ratio through the randomization system, and assigned to D-2570 group1, group 2 or placebo group. | Drug | Placebo group |
Primary outcome
The percentage of subjects with at least 90% improvement in PASI
Time frame: Day 1-Day 112
The percentage of subjects with at least 90% improvement in PASI from baseline at week 16 of treatment.
20 secondary outcomes
Percentage of subjects with a PGA
Time frame: Day 1-Day 112
The percentage of subjects with at least 75% improvement in PASI
Time frame: Day1-Day365
The percentage of subjects with at least 90% improvement in PASI
Time frame: Day1-Day365
The percentage of subjects with at least 100% improvement in PASI
Time frame: Day1-Day365
The percentage of subjects with improvement in PASI
Time frame: Day1-Day365
Percentage of subjects with a PGA
Time frame: Day1-Day365
The percentage of subjects with at least 90% improvement in PASI
Time frame: Day1-Day365
Percentage of subjects with a PGA score of 0 or 1 and ≥2 points from baseline
Time frame: Day1-Day365
Percentage of subjects with baseline ss-PGA score ≥3
Time frame: Day 1-Day 112
Percentage of subjects with baseline PGA-F score ≥3
Time frame: Day 1-Day 112
Percentage of subjects with baseline pp-PGA score ≥3
Time frame: Day 1-Day 112
Percentage of subjects with baseline DLQI score ≥2
Time frame: Day 1-Day 112
The main PK parameters -Time to maximum measured plasma concentration -Tmax Population pharmacokinetic characteristics of D-2570
Time frame: Day1-Day365
The main PK parameters#Area under the plasma concentration versus time curve-AUC
Time frame: Day1-Day365
The main PK parameters-Vz/F (apparent volume of distribution)
Time frame: Day1-Day365
The main PK parameters Half-life -t1/2
Time frame: Day1-Day365
The main PK parameters-CL/F (apparent clearance)
Time frame: Day1-Day365
Weight and height will be combined to report BMI in kg/m^2
Time frame: Day1-Day365
Incidence and severity of AEs based on NCI CTCAE V5.0
Time frame: Day1-Day365
Incidence and severity of TEAEs based on NCI CTCAE V5.0
Time frame: Day1-Day365
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 9 Dec 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.
Jianzhong Zhang principal investigator
Study Official is required by the WHO and ICMJE.
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 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 4 inclusion and 5 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 9 Dec 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 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 Nan Tang (021-50663661, nan.tang@inventisbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The percentage of subjects with at least 90% improvement in PASI (time frame: Day 1-Day 112). 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 9 Dec 2025.