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Not yet recruitingNCT06779097Updated Jan 16, 2025

Phase IV Study: Vunakizumab Efficacy and Safety in Moderate-to-severe Plaque Psoriasis

A Phase 4 interventional study of Vunakizumab (IL-17A inhibitor) in Moderate to Severe Plaque Psoriasis, sponsored by Suzhou Suncadia Biopharmaceuticals Co., Ltd.. Not yet recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-01-16.

Sponsored by Suzhou Suncadia Biopharmaceuticals Co., Ltd. (part of Jiangsu HengRui Medicine Co., Ltd.) · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
1,564
Allocation
Not applicable
Ages
18 Years and older
Sex
All
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Study 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. To explore the efficacy of difficult-to-treat area, patient satisfaction and patient-reported outcomes (PRO).

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Conditions studied

  • Moderate to Severe Plaque Psoriasis
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In context

Lead sponsor

Suzhou Suncadia Biopharmaceuticals Co., Ltd. is the lead sponsor of 102 studies on the registry; 71 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Age ≥18 years old at the time of signing the informed consent, regardless of gender;
  2. Diagnosed with moderate to severe plaque psoriasis;
  3. 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;
  4. 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.

Exclusion criteria

Exclusion Criteria:

  1. Patients previously treated with IL-17A inhibitors (IL-17Ai) had primary failure;
  2. Patients who had previously used IL-17A inhibitors (IL-17Ai) and experienced drug-related adverse events leading to drug withdrawal;
  3. Patients with severe hypersensitivity to the active ingredient or any excipients of Vunakizumab;
  4. 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;
  5. Patients with clinically important active diseases, such as active tuberculosis, active hepatitis, and active malignant tumors;
  6. Any other circumstances that the investigator believes will prevent the subject from following and completing the study protocol.
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Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
1,564 participants (estimated)

Study arms

  • Experimental
    Vunakizumab (IL-17A inhibitor)

    Drug: Vunakizumab (IL-17A inhibitor)

Interventions

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What researchers measure

Primary outcomes

  1. 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

  2. Proportion of subjects achieving sPGA 0/1 response at week 12.

    Time frame: Three months

Secondary outcomes

  1. 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

  2. The time when subjects reached PASI 75 and PASI 90 within 12 weeks

    Time frame: Three months

  3. The time when subjects reached PASI 75, PASI 90, PASI 100 within 52 weeks.

    Time frame: Twelve months

  4. Changes in PASI scores relative to baseline at each visit during 52 weeks.

    Time frame: Twelve months

  5. 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

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Study locations

1 site
  • China-Japan Friendship Hospital
    Beijing, Beijing Municipality 100029, China
    • Yong Cui · Principal investigator
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 16, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06779097
Responsible party
Sponsor
First posted
Jan 16, 2025
Start date
Feb 2025 (estimated)
Primary completion
Mar 2027 (estimated)
Completion
Feb 2028 (estimated)
Last update
Jan 16, 2025

Study contacts

Haixue Dai
Contact
haixue.dai@hengrui.com
+86 18006296526

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Vunakizumab

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