Plaque PsoriasisPhase 2NCT06278350
Evaluate the Efficacy and Safety of D-2570 in Participants With Moderate-to-Severe Plaque Psoriasis
A Phase 2 study testing D-2570 in people with Plaque Psoriasis, run by InventisBio Co., Ltd at 1 site in China.
Trial summary
This is a randomized, double-blind, placebo-controlled, multicenter clinical trial in participants 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
- 161 participants
- Where
- 1 siteChina
- Study dates
- 31 Jan 2024to 1 Nov 2024
- 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 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.
About this study
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of D-2570 in Participants With Moderate-to-Severe Plaque Psoriasis
This is a randomized, double-blind, placebo-controlled, multicenter clinical trial in participants with moderate-to-severe plaque psoriasis .
- 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 1:1:1:1 ratio through the randomization system, and assigned to D-2570 group
1, group 2, group 3 or placebo group.
PlaceboDrug
Randomized in a 1:1:1:1 ratio through the randomization system, and assigned to D-2570 group
1, group 2, group 3 or placebo group.
| Study group | Role | What they receive |
|---|---|---|
| D-2570 group 1 | Experimental | D-2570 group 1 Receives: Drug: D-2570 |
| D-2570 group 2 | Experimental | D-2570 group 2 Receives: Drug: D-2570 |
| D-2570 group 3 | Experimental | D-2570 group 3 Receives: Drug: D-2570 |
| Placebo group | Placebo comparator | Placebo group Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of subjects with at least 75% improvement in PASI
Percentage of subjects with at least 75% improvement in PASI from baseline at week 12 of treatment
Measured: Day 1-Day 85
Secondary outcomes (15)
Percentage of subjects with at least 75% improvement in PASI
Percentage of subjects with at least 75% improvement in PASI from baseline at weeks 4 and 8 of treatment;
Measured: Day 1-Day 56
Percentage of subjects with at least 90% improvement in PASI
Percentage of subjects with at least 90% improvement in PASI from baseline at weeks 4, 8, and 12 of treatment;
Measured: Day 1-Day 85
Percentage of subjects with 100% improvement in PASI
Percentage of subjects with 100% improvement in PASI from baseline at weeks 4, 8, and 12 of treatment;
Measured: Day 1-Day 85
Percentage improvement in PASI
Percentage improvement in PASI from baseline at weeks 4, 8, and 12 of treatment;
Measured: Day 1-Day 85
Percentage of subjects with a PGA
Percentage of subjects with a PGA score of 0 or 1 at weeks 4, 8, and 12 of treatment;
Measured: Day 1-Day 85
The main PK parameters ：Time to maximum measured plasma concentration（Tmax）
The main PK parameters ：Time to maximum measured plasma concentration（Tmax）
Measured: Day 1-Day 85
The main PK parameters ：Peak Plasma Concentration（Cmax)
The main PK parameters ：Peak Plasma Concentration（Cmax）
Measured: Day 1-Day 85
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: Day 1-Day 85
The main PK parameters：Vz/F (apparent volume of distribution)
The main PK parameters：Vz/F (apparent volume of distribution)
Measured: Day 1-Day 85
The main PK parameters： Half-life（t1/2）
The main PK parameters： Half-life（t1/2）
Measured: Day 1-Day 85
The main PK parameters： Mean Residence Time (MRT)
The main PK parameters： Mean Residence Time (MRT)
Measured: Day 1-Day 85
The main PK parameters：CL/F (apparent clearance)
The main PK parameters：CL/F (apparent clearance)
Measured: Day 1-Day 85
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: Day -28-Day 99
Incidence and severity of AEs based on NCI CTCAE V5.0
Incidence and severity of AEs based on NCI CTCAE V5.0
Measured: Day -28-Day 99
Incidence and severity of TEAEs based on NCI CTCAE V5.0
Incidence and severity of TEAEs based on NCI CTCAE V5.0
Measured: Day -28-Day 99
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2024
- Study start31 Jan 2024
- Primary completion1 Nov 2024
- Study completion1 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 161 participants (actual)
Sponsor and investigators
- Lead sponsor
- InventisBio Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jianzhong Zhang, Principal investigator, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06278350
- Sponsor's protocol ID
- D2570-201
- Status last verified
- Dec 2025
- First submitted
- 30 Jan 2024
- Last updated
- 9 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhang J, Zhou C, Miao G, Zhang S, Duan X, Wu L, Zhang G, Dang N, Ding Y, Han H, Wei A, Yang B, Li L, Li S, Dai X, Zhang J, Lei T, Yan W, Zhang L, Meng Z, Chen R, Song Q, Wang L, Wang W, Hu X, Xiang Z, Shi Z, Zhang L. Novel TYK2 inhibitor D-2570 in moderate-to-severe plaque psoriasis: A randomized, double-blind, placebo-controlled, phase 2 trial. J Am Acad Dermatol. 2026 Jan;94(1):143-150. doi: 10.1016/j.jaad.2025.09.036. Epub 2025 Sep 16.
PubMed 40967307
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 II Clinical Study to Evaluate the Efficacy and Safety of D-2570 in Participants With Moderate-to-Severe Plaque Psoriasis
- ClinicalTrials.gov ID
- NCT06278350
- Acronym / sponsor ID
- D2570-201
- Conditions
- Plaque Psoriasis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 161 participants (actual)
- Lead sponsor
- InventisBio Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 31 Jan 2024 (actual)
- Primary completion
- 1 Nov 2024 (actual)
- Study completion
- 1 Nov 2024 (actual)
- First posted
- 26 Feb 2024 (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 a randomized, double-blind, placebo-controlled, multicenter clinical trial in participants with moderate-to-severe plaque psoriasis .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| D-2570 group 1 | Experimental | Drug: D-2570D-2570 group 1 |
| D-2570 group 2 | Experimental | Drug: D-2570D-2570 group 2 |
| D-2570 group 3 | Experimental | Drug: D-2570D-2570 group 3 |
| Placebo group | Placebo comparator | Drug: PlaceboPlacebo group |
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 1:1:1:1 ratio through the randomization system, and assigned to D-2570 group 1, group 2, group 3 or placebo group. | Drug | D-2570 group 1, D-2570 group 2, D-2570 group 3 |
| PlaceboRandomized in a 1:1:1:1 ratio through the randomization system, and assigned to D-2570 group 1, group 2, group 3 or placebo group. | Drug | Placebo group |
Primary outcome
Percentage of subjects with at least 75% improvement in PASI
Time frame: Day 1-Day 85
Percentage of subjects with at least 75% improvement in PASI from baseline at week 12 of treatment
15 secondary outcomes
Percentage of subjects with at least 75% improvement in PASI
Time frame: Day 1-Day 56
Percentage of subjects with at least 90% improvement in PASI
Time frame: Day 1-Day 85
Percentage of subjects with 100% improvement in PASI
Time frame: Day 1-Day 85
Percentage improvement in PASI
Time frame: Day 1-Day 85
Percentage of subjects with a PGA
Time frame: Day 1-Day 85
The main PK parameters ：Time to maximum measured plasma concentration（Tmax）
Time frame: Day 1-Day 85
The main PK parameters ：Peak Plasma Concentration（Cmax)
Time frame: Day 1-Day 85
The main PK parameters：Area under the plasma concentration versus time curve（AUC）
Time frame: Day 1-Day 85
The main PK parameters：Vz/F (apparent volume of distribution)
Time frame: Day 1-Day 85
The main PK parameters： Half-life（t1/2）
Time frame: Day 1-Day 85
The main PK parameters： Mean Residence Time (MRT)
Time frame: Day 1-Day 85
The main PK parameters：CL/F (apparent clearance)
Time frame: Day 1-Day 85
Weight and height will be combined to report BMI in kg/m^2
Time frame: Day -28-Day 99
Incidence and severity of AEs based on NCI CTCAE V5.0
Time frame: Day -28-Day 99
Incidence and severity of TEAEs based on NCI CTCAE V5.0
Time frame: Day -28-Day 99
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 9 Dec 2025.
- Derived from this study: PubMed 40967307Zhang J, Zhou C, Miao G, Zhang S, Duan X, Wu L, Zhang G, Dang N, Ding Y, Han H, Wei A, Yang B, Li L, Li S, Dai X, Zhang J, Lei T, Yan W, Zhang L, Meng Z, Chen R, Song Q, Wang L, Wang W, Hu X, Xiang Z, Shi Z, Zhang L. Novel TYK2 inhibitor D-2570 in moderate-to-severe plaque psoriasis: A randomized, double-blind, placebo-controlled, phase 2 trial. J Am Acad Dermatol. 2026 Jan;94(1):143-150. doi: 10.1016/j.jaad.2025.09.036. Epub 2025 Sep 16.
- 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.
Jianzhong Zhang principal investigator
Peking University People's Hospital
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 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: finished, 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 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 subjects with at least 75% improvement in PASI (time frame: Day 1-Day 85). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06278350, which also lists 1 linked publication.
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.