Plaque PsoriasisPhase 3NCT07008547
To Evaluate the Efficacy and Safety of Netakimab in Chinese Patients With Moderate to Severe Plaque Psoriasis
A Phase 3 study testing Netakimab in people with Plaque Psoriasis, run by SPH-BIOCAD (HK) Limited at 1 site in China.
Trial summary
The goal of this clinical trial is to To evaluate the efficacy of subcutaneous (SC) Netakimab in adult Chinese patients with moderate to severe plaque psoriasis. Researchers will compare Netakimab to placebo to see if Netakimab works to treat plaque psoriasis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Plaque Psoriasis
- What is being tested?
- Netakimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 202 participants
- Where
- 1 siteChina
- Study dates
- 30 Jul 2024to 9 Mar 2026
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must voluntarily sign and date an Informed Consent Form (ICF) approved by the Ethics Committee (IEC) prior to any study-related procedures. The legal representative may also be asked to sign the ICF in accordance with local laws and regulations if necessary.
- Male or female, ≥ 18 years old at the time of signing the ICF.
- Patients with plaque psoriasis diagnosed at least for 6 months prior to signing the ICF.
- Patients who have inadequate response or intolerance to phototherapy or systemic drug therapy (biological or non-biological agents other than IL-17/IL-17R inhibitors) for psoriasis, or meet the above treatment indications in the opinion of the investigator.
- Patients with psoriasis involved body surface area (BSA) of 10% or more, PASI score of 10 or more, and sPGA score of 3 or more at screening.
- WOCBP have a negative serum pregnancy test (no pregnancy test is required for women of non-childbearing potential).
- Patients of childbearing potential and their partners must implement reliable contraceptive measures as specified in the protocol from signing the ICF until 20 weeks after the last dose of study treatment (see Appendix 10 for details).
- Patients who have the ability to follow protocol procedures as judged by the investigator.
Who cannot join
- Patients with other types of psoriasis (e.g., erythrodermic psoriasis, pustular psoriasis, guttate psoriasis) or any other skin disorders (e.g., eczema) that may affect the treatment/evaluation of psoriasis, and patients with drug-induced psoriasis or a history of drug-induced psoriasis at screening.
- Patients who are unable or unwilling to undergo repeated subcutaneous injection and venipuncture (e.g., because of poor tolerability or lack of venous access).
- Patients who have received the prohibited drugs or vaccines as specified in the protocol:
- Patients with hepatitis B virus (HBV) infection, hepatitis C virus (HCV) infection, human immunodeficiency virus (HIV) infection, treponema pallidum (TP) infection.
- Patients meeting any of the following criteria for laboratory tests at screening: serum creatinine (Cr) > 1.5 × upper limit of normal (ULN); alanine aminotransferase (ALT), aspartate aminotransferase (AST), or alkaline phosphatase (ALP) > 2.5 × ULN; total bilirubin (TBIL) > 1.5 × ULN; white blood cell (WBC) count < 3.0 × 109/L; absolute neutrophil count (ANC) < 2.0 × 109/L; platelet (PLT) count < 100 × 109/L; hemoglobin (Hb) < 90 g/L.
- Patients with any psychiatric disorders, including serious depressive disorder, or history of strong suicidal ideation or suicide intention; or clinically significant symptoms of depression (Beck score ≥ 16 at screening), which require intervention treatment determined by a specialist.
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- Patients with history or evidence of alcohol or drug abuse.
- Patients with active tuberculosis infection or history of tuberculosis, or current latent tuberculosis infection [positive for interferon gamma release assay (QuantiFERON TB-Gold or T-SPOT etc.)].
- Patients with other diseases that may affect the assessment of psoriasis or any other underlying disease (including, but not limited to, clinically significant cardiac, hepatic, renal, respiratory, immune, neurological, endocrine, metabolic, blood, gastrointestinal, or psychiatric disorders) that, in the opinion of the investigator, study treatment may place the patient at additional risks
- Patients with current or previous malignant tumor within the past 5 years [except adequately treated (cured) squamous cell carcinoma or basalioma, cervical uteri cancer in situ or in situ breast ductal carcinoma].
- Patients with known history of serious allergies (allergies to two or more drugs or systemic allergic reactions).
- Patients with known allergies or intolerance to monoclonal antibody drugs or any other component of the investigational product or placebo.
- Patients who have had major surgery within 30 days prior to screening or scheduled for major surgeries at any time during the study.
- Patients with active infection or medical history:
- Patients with epileptic seizure or the history of epileptic seizure.
- Patients who are pregnant, breastfeeding, or planning pregnancy at the time of study participation.
- Patients who have participated in any other clinical study or within 3 months prior to signing the ICF or are concurrently participating in other clinical studies.
- Patients who have other conditions that are not suitable for participation in the study in the judgment of the investigat
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Clinical Study to Evaluate the Efficacy, Safety, and Pharmacokinetic Profile and Immunogenicity of Subcutaneous Netakimab in Chinese Adult Patients With Moderate to Severe Plaque Psoriasis
The goal of this clinical trial is to To evaluate the efficacy of subcutaneous (SC) Netakimab in adult Chinese patients with moderate to severe plaque psoriasis. Researchers will compare Netakimab to placebo to see if Netakimab works to treat plaque psoriasis.
- Conditions
- Plaque Psoriasis
- Being tested
- Netakimab, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NetakimabBiological
Netakimab administered subcutaneously
PlaceboDrug
Placebo administered subcutaneously
| Study group | Role | What they receive |
|---|---|---|
| Netakimab | Experimental | Netakimab administered by subcutaneous injection until Week 52 Receives: Biological: Netakimab |
| Placebo | Placebo comparator | Placebo administered by subcutaneous injection until Week 12 then Netakimab subcutaneous injection until 52 week Receives: Biological: Netakimab; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects achieving PASI75
Proportion of subjects with a Psoriatic Area and Severity Index (PASI) score improved by at least 75% (to achieve a PASI 75 response) relative to the baseline PASI score at Week 12
Measured: at week 12
Proportion of subjects achieving sPGA0/1
Proportion of subjects with a sPGA(Static Physician Global Assessment) either 0 or 1 at Week 12
Measured: at week 12
Secondary outcomes (5)
Proportion of subjects achieving PASI75
Proportion of subjects with a Psoriatic Area and Severity Index (PASI) score improved by at least 75% (to achieve a PASI 75 response) relative to the baseline PASI score through out the study
Measured: through out the study(From baseline to Week 62)
Proportion of subjects achieving PASI90
Proportion of subjects with a Psoriatic Area and Severity Index (PASI) score improved by at least 90% (to achieve a PASI90 response) relative to the baseline PASI score through out the study
Measured: through out the study(From baseline to Week 62)
Proportion of subjects achieving PASI100
Proportion of subjects with a Psoriatic Area and Severity Index (PASI) score improved by at least100% (to achieve a PASI100 response) relative to the baseline PASI score through out the study
Measured: through out the study(From baseline to Week 62)
Proportion of subjects achieving PGA
Proportion of subjects with a sPGA(Static Physician Global Assessment) either 0 or 1 through out the study
Measured: through out the study(From baseline to Week 62)
Changes from baseline in NAPSI score
Changes from baseline in NAPSI score through out the study
Measured: through out the study(From baseline to Week 52)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2025
- Study start30 Jul 2024
- Primary completion28 Mar 2025
- Study completion9 Mar 2026
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.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 202 participants (actual)
Sponsor and investigators
- Lead sponsor
- SPH-BIOCAD (HK) Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07008547
- Sponsor's protocol ID
- BCD-085-CN01
- Status last verified
- May 2025
- First submitted
- 28 May 2025
- Last updated
- 10 Sep 2026
- 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 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Multicenter Clinical Study to Evaluate the Efficacy, Safety, and Pharmacokinetic Profile and Immunogenicity of Subcutaneous Netakimab in Chinese Adult Patients With Moderate to Severe Plaque Psoriasis
- ClinicalTrials.gov ID
- NCT07008547
- Acronym / sponsor ID
- BCD-085-CN01
- Conditions
- Plaque Psoriasis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 202 participants (actual)
- Lead sponsor
- SPH-BIOCAD (HK) LimitedIndustry (pharma, biotech, devices)
- Study start
- 30 Jul 2024 (actual)
- Primary completion
- 28 Mar 2025 (actual)
- Study completion
- 9 Mar 2026 (actual)
- First posted
- 6 Jun 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.
The goal of this clinical trial is to To evaluate the efficacy of subcutaneous (SC) Netakimab in adult Chinese patients with moderate to severe plaque psoriasis. Researchers will compare Netakimab to placebo to see if Netakimab works to treat plaque psoriasis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Netakimab | Experimental | Biological: NetakimabNetakimab administered by subcutaneous injection until Week 52 |
| Placebo | Placebo comparator | Biological: Netakimab, Drug: PlaceboPlacebo administered by subcutaneous injection until Week 12 then Netakimab subcutaneous injection until 52 week |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients must voluntarily sign and date an Informed Consent Form (ICF) approved by the Ethics Committee (IEC) prior to any study-related procedures. The legal representative may also be asked to sign the ICF in accordance with local laws and regulations if necessary.
- Male or female, ≥ 18 years old at the time of signing the ICF.
- Patients with plaque psoriasis diagnosed at least for 6 months prior to signing the ICF.
- Patients who have inadequate response or intolerance to phototherapy or systemic drug therapy (biological or non-biological agents other than IL-17/IL-17R inhibitors) for psoriasis, or meet the above treatment indications in the opinion of the investigator.
- Patients with psoriasis involved body surface area (BSA) of 10% or more, PASI score of 10 or more, and sPGA score of 3 or more at screening.
Key exclusion criteria (18 listed)
- Patients with other types of psoriasis (e.g., erythrodermic psoriasis, pustular psoriasis, guttate psoriasis) or any other skin disorders (e.g., eczema) that may affect the treatment/evaluation of psoriasis, and patients with drug-induced psoriasis or a history of drug-induced psoriasis at screening.
- Patients who are unable or unwilling to undergo repeated subcutaneous injection and venipuncture (e.g., because of poor tolerability or lack of venous access).
- Patients who have received the prohibited drugs or vaccines as specified in the protocol:
- Patients with hepatitis B virus (HBV) infection, hepatitis C virus (HCV) infection, human immunodeficiency virus (HIV) infection, treponema pallidum (TP) infection.
- Patients meeting any of the following criteria for laboratory tests at screening: serum creatinine (Cr) > 1.5 × upper limit of normal (ULN); alanine aminotransferase (ALT), aspartate aminotransferase (AST), or alkaline phosphatase (ALP) > 2.5 × ULN; total bilirubin (TBIL) > 1.5 × ULN; white blood cell (WBC) count < 3.0 × 109/L; absolute neutrophil count (ANC) < 2.0 × 109/L; platelet (PLT) count < 100 × 109/L; hemoglobin (Hb) < 90 g/L.
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 |
|---|---|---|
| NetakimabNetakimab administered subcutaneously | Biological | Netakimab, Placebo |
| PlaceboPlacebo administered subcutaneously | Drug | Placebo |
Primary outcome
Proportion of subjects achieving PASI75
Time frame: at week 12
Proportion of subjects with a Psoriatic Area and Severity Index (PASI) score improved by at least 75% (to achieve a PASI 75 response) relative to the baseline PASI score at Week 12
Proportion of subjects achieving sPGA0/1
Time frame: at week 12
Proportion of subjects with a sPGA(Static Physician Global Assessment) either 0 or 1 at Week 12
5 secondary outcomes
Proportion of subjects achieving PASI75
Time frame: through out the study(From baseline to Week 62)
Proportion of subjects achieving PASI90
Time frame: through out the study(From baseline to Week 62)
Proportion of subjects achieving PASI100
Time frame: through out the study(From baseline to Week 62)
Proportion of subjects achieving PGA
Time frame: through out the study(From baseline to Week 62)
Changes from baseline in NAPSI score
Time frame: through out the study(From baseline to Week 52)
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 10 Sep 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Netakimab in people with Plaque Psoriasis, run by SPH-BIOCAD (HK) Limited 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 8 inclusion and 18 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 10 Sep 2026. 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?
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?
Proportion of subjects achieving PASI75 (time frame: at week 12). 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 10 Sep 2026.