Moderate to Severe Plaque PsoriasisNCT06696417
Phase IV Study: Vunakizumab Efficacy and Safety in Moderate-to-severe Plaque Psoriasis
An observational study of Moderate to Severe Plaque Psoriasis, run by First Hospital of China Medical University at 1 site in China.
Trial summary
This is a multicenter, prospective, observational study of 1516 patients with moderate-to-severe chronic plaque psoriasis to evaluate the efficacy and safety of vunakizumab in patients with moderate-to-severe chronic plaque psoriasis. Approximately 50-100 clinical trial centers are planned to participate in the study. 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?
- Drug group：vunakizumab (IL-17A inhibitor)
- Type of treatment
- Injection or infusion
- How many people
- 1,516 participants
- Where
- 1 siteChina
- Study dates
- 17 Feb 2025to Apr 2028
- How long will I take part?
- 60 Weeks
- Phase
- Observational
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
Study population: Moderate and severe plaque psoriasis
Who may be able to join
- Age ≥18 years old at the time of signing the informed consent, regardless of gender;
- Moderate to severe plaque psoriasis was diagnosed;
- Plan to receive vunakizumab therapy as assessed by the investigator;
- 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 voluntarily sign informed consent forms.
Who cannot join
- Previous treatment with biological agents: including but not limited to anti-tumor necrosis factor-α (TNF-α), anti-IL-17, anti-IL-17 receptor, anti-IL-12 /IL-23 or IL-23p19 antibody drugs;
- Severe hypersensitivity to vunakizumab active ingredient or any excipients;
- Patients with clinically important active diseases, such as active tuberculosis, active hepatitis, and active malignant tumors;
- 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 last receiving the study drug;
- 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, 1 recruiting
- Recruiting
The First Hospital of China Medical University
Shenyang, Liaoning
xinghua gao, +86 24 83282116, gaobarry@hotmail.com
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 Not Previously Received Biologics
This is a multicenter, prospective, observational study of 1516 patients with moderate-to-severe chronic plaque psoriasis to evaluate the efficacy and safety of vunakizumab in patients with moderate-to-severe chronic plaque psoriasis. Approximately 50-100 clinical trial centers are planned to participate in the study. The study consisted of a 7-day screening period, a 52-week treatment period and an 8-week safety follow-up period.
The recommended dose of vunakizumab is 240 mg (120 mg in two injections), with subcutaneous injection at week 0, 2, and 4, followed by a dose every 4 weeks and a final injection at week 48 (the actual treatment regimen is based on the clinician's recommendation). After the corresponding assessment at 52 weeks, an 8-week safety follow-up period was entered until the end of the study.
Read the detailed description
The vunakizumab is a humanized IL-17A inhibitor with innovative binding epitopes, which accurately binds to IL-17A, the core pathogenic factor of psoriasis. However, there is still a lack of efficacy and safety data in a large sample size of the Chinese population after marketing. Therefore, this study is intended to observe the efficacy and safety of vunachizumab in a larger population. The clinical efficacy of vunakizumab on special sites and the influence of comorbidity on the treatment of psoriasis are also paid attention to. At the same time, the improvement effect of vunakizumab on the quality of life and mental health of psoriasis patients is explored through patient-reported outcome (PRO) and patient satisfaction survey, so as to develop a clinical program that can benefit psoriasis patients physically and mentally.
- Conditions
- Moderate to Severe Plaque Psoriasis
- Being tested
- Drug group：vunakizumab (IL-17A inhibitor)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drug group：vunakizumab (IL-17A inhibitor)Drug
The recommended dose of vunakizumab was 240 mg, administered subcutaneously at weeks 0, 2, and 4, then every 4 weeks, with a final injection at 48 weeks
What is being measured
The primary outcome is the main question the study is designed to answer.
The overall clinical clearance rate of skin lesions
- The proportion of subjects who achieved at least a 90% improvement from baseline in PASI scores by week 12 (PASI 90). (PASI: Psoriasis Area and Severity Index, 0 ≤ PASI ≤ 72, where a higher score indicates a greater extent of the disease and more severe skin lesion severity.)
- Proportion of subjects achieving sPGA 0/1 response at week 12. (sPGA 0/1 response is defined as an sPGA score of 0 (clear) or 1 (almost clear))
Measured: Three months
Secondary outcomes (6)
The overall clinical clearance rate of skin lesions
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 at 52 weeks.
Measured: Twelve months
Changes in PASI scores relative to baseline at each visit point 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.
ACR20 refers to the improvement of at least 20% in the number of swollen and tender joints in rheumatoid arthritis treatment, along with improvement of at least 20% in at least three of the other five assessment criteria. ACR50 and ACR70 are defined using the same criteria, representing a 50% and 70% improvement, respectively.
Measured: One month， Three months， Six months，Twelve months
Weeks 12 and 52 Treatment Satisfaction Questionnaire for Medication (TSQM) survey questionnaire.
0 ≤ TSQM ≤ 100, where a higher score indicates greater patient satisfaction with the medication
Measured: Three 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 posted20 Nov 2024
- Study start17 Feb 2025
- Primary completionApr 2028 (estimated)
- Study completionApr 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.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 1,516 participants (estimated)
- Target duration
- 60 Weeks
Sponsor and investigators
- Lead sponsor
- First Hospital of China Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gao Xinghua, First Hospital of China Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06696417
- Sponsor's protocol ID
- MA-DER-RWS-001
- Status last verified
- May 2025
- First submitted
- 12 Nov 2024
- Last updated
- 14 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No