Moderate to Severe Plaque PsoriasisPhase 4NCT06779097
Phase IV Study: Vunakizumab Efficacy and Safety in Moderate-to-severe Plaque Psoriasis
A Phase 4 study testing Vunakizumab (IL-17A inhibitor) in people with Moderate to Severe Plaque Psoriasis, run by Suzhou Suncadia Biopharmaceuticals Co., Ltd. at 1 site in China.
Trial summary
This is a prospective, single-arm, multicenter, Phase IV study of 1564 patients with moderate-to-severe chronic plaque psoriasis to evaluate the efficacy and safety of Vunakizumab in patients with moderate-to-severe plaque psoriasis who have converted from other biologics. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Moderate to Severe Plaque Psoriasis
- What is being tested?
- Vunakizumab (IL-17A inhibitor)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,564 participants
- Where
- 1 siteChina
- Study dates
- Feb 2025to Feb 2028
- Phase
- Phase 4
- 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
- Age ≥18 years old at the time of signing the informed consent, regardless of gender;
- Diagnosed with moderate to severe plaque psoriasis;
- The subject voluntarily signs informed consent before the start of any procedures related to the study, can communicate with the researcher smoothly, understands and is willing to strictly comply with the requirements of this clinical study protocol to complete the study;
- Patients who have been treated with biologics for ≥12 weeks prior to screening and are in line with the biologics conversion recommendations of the Chinese Guidelines for the Treatment of Psoriasis Biologics and Small Molecule Drugs (2024 edition), and who have been screened and evaluated by researchers as eligible for biologics therapy.
Who cannot join
- Patients previously treated with IL-17A inhibitors (IL-17Ai) had primary failure;
- Patients who had previously used IL-17A inhibitors (IL-17Ai) and experienced drug-related adverse events leading to drug withdrawal;
- Patients with severe hypersensitivity to the active ingredient or any excipients of Vunakizumab;
- Fertile women (defined as all women with physical conditions necessary for pregnancy) and men who are pregnant or unwilling or unable to use highly effective birth control during the study period and within 20 weeks after the last receipt of the study drug;
- Patients with clinically important active diseases, such as active tuberculosis, active hepatitis, and active malignant tumors;
- Any other circumstances that the investigator believes will prevent the subject from following and completing the study protocol.
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
China-Japan Friendship Hospital
Beijing, Beijing Municipality, 100029
Yong Cui
About this study
Official title: A Prospective, Single-arm, Multicenter, Phase IV Study to Evaluate the Efficacy and Safety of Vunakizumab in Adults With Moderate-to-severe Plaque Psoriasis Who Have Converted From Other Biologics
This is a prospective, single-arm, multicenter, Phase IV study of 1564 patients with moderate-to-severe chronic plaque psoriasis to evaluate the efficacy and safety of Vunakizumab in patients with moderate-to-severe plaque psoriasis who have converted from other biologics. To explore the efficacy of difficult-to-treat area, patient satisfaction and patient-reported outcomes (PRO).
- Conditions
- Moderate to Severe Plaque Psoriasis
- Being tested
- Vunakizumab (IL-17A inhibitor)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vunakizumab (IL-17A inhibitor)Drug
Vunakizumab (IL-17A inhibitor)
| Study group | Role | What they receive |
|---|---|---|
| Vunakizumab (IL-17A inhibitor) | Experimental | Not described Receives: Drug: Vunakizumab (IL-17A inhibitor) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of subjects who achieved at least a 90% improvement from baseline in PASI scores by week 12 (PASI 90).
Measured: Three months
Proportion of subjects achieving sPGA 0/1 response at week 12.
Measured: Three months
Secondary outcomes (5)
Proportion of subjects with PASI 75, PASI 90, PASI 100, sPGA 0/1, and sPGA 0 at week 4, 12, and 52.
Measured: One month， Three months，Twelve months
The time when subjects reached PASI 75 and PASI 90 within 12 weeks
Measured: Three months
The time when subjects reached PASI 75, PASI 90, PASI 100 within 52 weeks.
Measured: Twelve months
Changes in PASI scores relative to baseline at each visit during 52 weeks.
Measured: Twelve months
Response rates of ACR (American College of Rheumatology) 20, ACR50 and ACR70 at week 4, 12, 24 and 52.
Measured: One month， Three months， Six months，Twelve months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2025
- Study startFeb 2025 (estimated)
- Primary completionMar 2027 (estimated)
- Study completionFeb 2028 (estimated)
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 Suncadia Biopharmaceuticals 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,564 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06779097
- Sponsor's protocol ID
- MA-DER-RWS-002
- Status last verified
- Jan 2025
- First submitted
- 7 Jan 2025
- Last updated
- 16 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-arm, Multicenter, Phase IV Study to Evaluate the Efficacy and Safety of Vunakizumab in Adults With Moderate-to-severe Plaque Psoriasis Who Have Converted From Other Biologics
- ClinicalTrials.gov ID
- NCT06779097
- Acronym / sponsor ID
- MA-DER-RWS-002
- Conditions
- Moderate to Severe Plaque Psoriasis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,564 participants (estimated)
- Lead sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Feb 2025 (estimated)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 16 Jan 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 is a prospective, single-arm, multicenter, Phase IV study of 1564 patients with moderate-to-severe chronic plaque psoriasis to evaluate the efficacy and safety of Vunakizumab in patients with moderate-to-severe plaque psoriasis who have converted from other biologics. To explore the efficacy of difficult-to-treat area, patient satisfaction and patient-reported outcomes (PRO).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vunakizumab (IL-17A inhibitor) | Experimental | Drug: Vunakizumab (IL-17A inhibitor) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥18 years old at the time of signing the informed consent, regardless of gender;
- Diagnosed with moderate to severe plaque psoriasis;
- The subject voluntarily signs informed consent before the start of any procedures related to the study, can communicate with the researcher smoothly, understands and is willing to strictly comply with the requirements of this clinical study protocol to complete the study;
- Patients who have been treated with biologics for ≥12 weeks prior to screening and are in line with the biologics conversion recommendations of the Chinese Guidelines for the Treatment of Psoriasis Biologics and Small Molecule Drugs (2024 edition), and who have been screened and evaluated by researchers as eligible for biologics therapy.
Key exclusion criteria (6 listed)
- Patients previously treated with IL-17A inhibitors (IL-17Ai) had primary failure;
- Patients who had previously used IL-17A inhibitors (IL-17Ai) and experienced drug-related adverse events leading to drug withdrawal;
- Patients with severe hypersensitivity to the active ingredient or any excipients of Vunakizumab;
- Fertile women (defined as all women with physical conditions necessary for pregnancy) and men who are pregnant or unwilling or unable to use highly effective birth control during the study period and within 20 weeks after the last receipt of the study drug;
- Patients with clinically important active diseases, such as active tuberculosis, active hepatitis, and active malignant tumors;
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 |
|---|---|---|
| Vunakizumab (IL-17A inhibitor)Vunakizumab (IL-17A inhibitor) | Drug | Vunakizumab (IL-17A inhibitor) |
Primary outcome
The proportion of subjects who achieved at least a 90% improvement from baseline in PASI scores by week 12 (PASI 90).
Time frame: Three months
Proportion of subjects achieving sPGA 0/1 response at week 12.
Time frame: Three months
5 secondary outcomes
Proportion of subjects with PASI 75, PASI 90, PASI 100, sPGA 0/1, and sPGA 0 at week 4, 12, and 52.
Time frame: One month， Three months，Twelve months
The time when subjects reached PASI 75 and PASI 90 within 12 weeks
Time frame: Three months
The time when subjects reached PASI 75, PASI 90, PASI 100 within 52 weeks.
Time frame: Twelve months
Changes in PASI scores relative to baseline at each visit during 52 weeks.
Time frame: Twelve months
Response rates of ACR (American College of Rheumatology) 20, ACR50 and ACR70 at week 4, 12, 24 and 52.
Time frame: One month， Three months， Six months，Twelve months
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 16 Jan 2025.
- Individual participant dataSharing planned: Undecided
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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 4 study testing Vunakizumab (IL-17A inhibitor) in people with Moderate to Severe Plaque Psoriasis, run by Suzhou Suncadia 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 4 inclusion and 6 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 16 Jan 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 Haixue Dai (+86 18006296526, haixue.dai@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of subjects who achieved at least a 90% improvement from baseline in PASI scores by week 12 (PASI 90). (time frame: Three months). The study lists 2 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 16 Jan 2025.