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PsoriasisPhase 3NCT06398652

Comparative Study of CMAB015 and Secukinumab for Patients With Moderate to Severe Plaque Psoriasis

A Phase 3 study testing CMAB015 and Secukinumab in people with Psoriasis, run by Taizhou Mabtech Pharmaceutical Co.,Ltd at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The goal of this trial is to assess whether the efficacy of CMAB015 is similar to that of Secukinumab in patients with moderate-severe chronic plaque psoriasis. It will also learn about the similarity of CMAB015 and Secukinumab in terms of safety and immunogenicity in patients with moderate-severe chronic plaque… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Psoriasis
What is being tested?
CMAB015 and Secukinumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
336 participants
Where
1 siteChina
Study dates
27 Aug 2024to 19 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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • History of confirmed moderate-severe plaque psoriasis for at least 6 months before randomization.
  • PASI scores≥12, IGA (mod 2011) scores ≥3 and BSA≥10% at screening and randomization.
  • With indications for phototherapy or systemic therapy.
  • Voluntarily sign informed consent.

Who cannot join

  • Presented with pustular psoriasis, erythrodermic psoriasis,guttate psoriasis or psoriasis triggered by medicine at screening.
  • Active persistent cutaneous inflammatory disease other than psoriasis at randomization.
  • Treatment with phototherapy, including but not limited to ultraviolet A phototherapy (with or without psoralen), ultraviolet B phototherapy, or excimer laser within 4 weeks prior to randomization. Patients who are unwilling to avoid excessive UV exposure within 4 weeks prior to randomization and during this trial.
  • Use of systemic treatment with anti-psoriasis non-biologic agents within 4 weeks prior to randomization, including but not limited to glucocorticoids, retinoids, cyclosporine, methotrexate, azathioprine, leflunomide, mycophenolate mofetil, tofacitinib, apremilast, traditional Chinese medicine/proprietary Chinese medicine, etc.
  • Intra-articular glucocorticoid injection within 4 weeks or 5 drug half-lives (whichever is longer) prior to randomization.
  • Topical anti-psoriasis treatment within 2 weeks prior to randomization.
Show all 23Show fewer
  • Prior treatment with the following biologic agents for the treatment of psoriasis within the specified time period prior to randomization: ustekinumab<6 months, Adalimumab, Etanercept, Infliximab, Golimumab, Guselkumab<12 weeks, Rituximab<12 months, or any other biological agent< 5 half lives.
  • Prior treatment with anti-IL-17 antibody or anti-IL-17 receptor antibody.
  • Meets any of the following at screening: haemoglobin<80 g/L, white blood cell<3×10E9/L, Neutrophils<1.5×10E9/L, platelet<75×10E9/L, alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) and/or total bilirubin (TBiL)>2 times the upper limit of normal (ULN), serum creatinine (Scr)>1.5 ULN.
  • History of inflammatory bowel disease or other disease with a high risk of perforation or other active autoimmune disease.
  • Systemic infection or serious infection requiring hospitalization and/or intravenous anti-infective therapy within 4 weeks prior to randomization; any active infection within 2 weeks prior to randomization, with the exception of general upper respiratory tract infection.
  • Have Received a live vaccine within 12 weeks prior to randomization, or plan to receive a live vaccine during the study or within 6 months after the last dose.
  • Previously diagnosed or ongoing lymphoproliferative disorders. Malignant tumors within 5 years prior to screening, excluding squamous cell carcinoma of the skin or basal cell carcinoma or unflavored cervical cancer that have been cured after treatment.
  • History of depression and/or any finding of suicidal ideation before randomization.
  • Concomitant progressive or uncontrolled cardiovascular and cerebrovascular diseases, respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, and neurological diseases, which are judged by the investigators to be inappropriate for participation in this study;
  • Positive for any of the followings: hepatitis B virus surface antigen, hepatitis C virus antibody ,human immunodeficiency virus antibody, treponema pallidum antibody.
  • Latent or active tuberculosis.
  • Allergy to anti-IL-17 antibody active ingredients, excipients or latex.
  • Pregnant or nursing women. Male or female patients who are unwilling to use effective contraception during the trial and for 5 months after the last dose
  • Participated in other drug clinical trials within 3 months or 5 drug half-lives (whichever is longer) before screening.
  • Any major surgery within 8 weeks prior to randomization, or planned major surgery during the study.
  • History of recurrent drug abuse or unprescribed medication, or history of alcohol abuse.
  • Other conditions judged by the investigator to be inappropriate to participate in this study.

Trial locations and contacts

1 site in 1 country.

China1 site
  • Huashan Hospital

    Shanghai

Other trials in China

About this study

Official title: Comparative Study of the Efficacy, Safety, and Immunogenicity of CMAB015 and Secukinumab in Adult Patients With Moderate-severe Chronic Plaque Psoriasis

The goal of this trial is to assess whether the efficacy of CMAB015 is similar to that of Secukinumab in patients with moderate-severe chronic plaque psoriasis. It will also learn about the similarity of CMAB015 and Secukinumab in terms of safety and immunogenicity in patients with moderate-severe chronic plaque psoriasis. The main question it aims to answer is:

In subjects with moderate to severe plate psoriasis treated with CMAB015, Is the proportion of patients achieving a 75% improvement in PASI (Psoriasis area and severity index) scores relative to baseline (PASI 75) the same as those treated with Secukinumab?

Read more

Participants will:

Receive treatment with 300 mg CMAB015 or Secukinumab by subcutaneous injection at weeks 0, 1, 2, 3, 4, and 8, followed by every 4 weeks until week 48.

Visit the clinic at weeks 0, 1, 2, 3, 4, and 8, followed by every 4 weeks until week 52.

Be evaluated with PASI scores, body surface area (BSA) scores and investigator's global assessment (IGA) (mod 2011) scores.

Read the detailed description

This study was a multicenter, randomized, double-blind, secukinumab controlled, 1:1 ratio parallel grouping, equivalent design. The study treatment period would be 52 weeks, including a 12-week induction therapy period and a 40-week maintenance therapy period. The primary endpoint was the proportion of patients achieving at least a 75% improvement in PASI scores from baseline at 12 weeks, with an equivalence cut-off of ±15%. A total of 336 adult patients with moderate-to-severe plaque psoriasis are planned to be enrolled, with 168 cases in each group. Eligible subjects received 300 mg CMAB015 or Secukinumab subcutaneous injection. Patients who do not achieve at least a 50% improvement in PASI scores at week 12 would withdraw from the study, and patients who achieve a 50% improvement continue on maintenance therapy until the last treatment at week 48.

This study is a double-blind design, and a central randomization system woud be used to randomize subjects. The control factors for randomization are body weight (<60 kg, ≥60 kg), prior treatment (prior systemic therapy with no prior biologics, prior systemic therapy with biologics), concomitant psoriatic arthritis (yes, no), and PK intensive sampling (yes, no).

Conditions
Psoriasis
Being tested
CMAB015, Secukinumab
Medical subject headings
Psoriasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CMAB015Biological

    Patients would receive 300 mg CMAB007 subcutaneous injections at week 0, 1, 2, 3, 4, 8 as induction therapy. Patients who obtain a 75% improvement relative to baseline in PASI scores would receive 300 mg CMAB007 subcutaneous injections every 4 weeks as maintain therapy, until the last treatment at week 48.

  • SecukinumabBiological

    Also called Cosentyx

    Patients would receive 300 mg secukinumab subcutaneous injections at week 0, 1, 2, 3, 4, 8 as induction therapy. Patients who obtain a 75% improvement relative to baseline in PASI scores would receive 300 mg secukinumab subcutaneous injections every 4 weeks as maintain therapy, until the last treatment at week 48.

Study groups in NCT06398652
Study groupRoleWhat they receive
Experimental ArmExperimentalCMAB015
Receives: Biological: CMAB015
Active Comparator ArmActive comparatorSecukinumab
Receives: Biological: Secukinumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of patients with PASI 75 at week 12.

    The Psoriasis Area and Severity Index (PASI) is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI 75 is defined as at least a 75% reduction in PASI scores compared with the Baseline PASI scores.

    Measured: week 12

Secondary outcomes (16)
  1. Proportion of patients with IGA (mod 2011) 0/1 at week 12.

    The modified version of Investigator's Global Assessment (IGA) wich was developed in 2011 (mod 2011) is a simple instrument providing a subjective evaluation of the overall severity of psoriasis. Erythema, induration, and scaling of psoriatic lesions are scored on a 5-point scale ranging from 0 (none) to 4 (severe) as the following:

    0=Clear (e.g., no signs of psoriasis, some post-inflammatory hyperpigmentation may be present) ; 1=Almost clear (e.g., no thickening, normal or pink coloration) ; 2=Mild (e.g., mild thickening, pink to light red coloration) ;3= Moderate (e.g., moderate thickening, dull to bright red) ; 4=Severe (e.g., severe thickening, bright to deep red) .

    Measured: week 12

  2. Proportion of patients with IGA (mod 2011) 0/1 at week 52.

    The modified version of Investigator's Global Assessment (IGA) wich was developed in 2011 (mod 2011) is a simple instrument providing a subjective evaluation of the overall severity of psoriasis. Erythema, induration, and scaling of psoriatic lesions are scored on a 5-point scale ranging from 0 (none) to 4 (severe) as the following:

    0=Clear (e.g., no signs of psoriasis, some post-inflammatory hyperpigmentation may be present) ; 1=Almost clear (e.g., no thickening, normal or pink coloration) ; 2=Mild (e.g., mild thickening, pink to light red coloration) ;3= Moderate (e.g., moderate thickening, dull to bright red) ; 4=Severe (e.g., severe thickening, bright to deep red) .

    Measured: week 52

  3. Proportion of patients with IGA (mod 2011) 0 at week 12.

    The modified version of Investigator's Global Assessment (IGA) wich was developed in 2011 (mod 2011) is a simple instrument providing a subjective evaluation of the overall severity of psoriasis. Erythema, induration, and scaling of psoriatic lesions are scored on a 5-point scale ranging from 0 (none) to 4 (severe) as the following:

    0=Clear (e.g., no signs of psoriasis, some post-inflammatory hyperpigmentation may be present) ; 1=Almost clear (e.g., no thickening, normal or pink coloration) ; 2=Mild (e.g., mild thickening, pink to light red coloration) ;3= Moderate (e.g., moderate thickening, dull to bright red) ; 4=Severe (e.g., severe thickening, bright to deep red) .

    Measured: week 12

  4. Proportion of patients with IGA (mod 2011) 0 at week 52.

    The modified version of Investigator's Global Assessment (IGA) wich was developed in 2011 (mod 2011) is a simple instrument providing a subjective evaluation of the overall severity of psoriasis. Erythema, induration, and scaling of psoriatic lesions are scored on a 5-point scale ranging from 0 (none) to 4 (severe) as the following:

    0=Clear (e.g., no signs of psoriasis, some post-inflammatory hyperpigmentation may be present) ; 1=Almost clear (e.g., no thickening, normal or pink coloration) ; 2=Mild (e.g., mild thickening, pink to light red coloration) ;3= Moderate (e.g., moderate thickening, dull to bright red) ; 4=Severe (e.g., severe thickening, bright to deep red) .

    Measured: week 52

  5. Proportion of patients with PASI 50 at week 12.

    The Psoriasis Area and Severity Index (PASI) is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI 50 is defined as at least a 50% reduction in PASI scores compared with the Baseline PASI scores.

    Measured: week 12

  6. Proportion of patients with PASI 75 at week 52.

    The Psoriasis Area and Severity Index (PASI) is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI 75 is defined as at least a 75% reduction in PASI scores compared with the Baseline PASI scores.

    Measured: week 52

  7. Proportion of patients with PASI 90 at week 12.

    The Psoriasis Area and Severity Index (PASI) is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI 90 is defined as at least a 90% reduction in PASI scores compared with the Baseline PASI scores.

    Measured: week 12

  8. Proportion of patients with PASI 90 at week 52.

    The Psoriasis Area and Severity Index (PASI) is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI 90 is defined as at least a 90% reduction in PASI scores compared with the Baseline PASI scores.

    Measured: week 52

  9. Proportion of patients with PASI 100 at week 12.

    The Psoriasis Area and Severity Index (PASI) is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI 100 is defined as complete remission.

    Measured: week 12

  10. Proportion of patients with PASI 100 at week 52.

    The Psoriasis Area and Severity Index (PASI) is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI 100 is defined as complete remission..

    Measured: week 52

  11. Change from baseline in DLQI at week 52

    The Dermatology Life Quality Index (DLQI) is the most commonly used dermatology-specific quality of life (QOL) measure in clinical trials of skin diseases. It consists of 10 questions concerning dermatologic patients' perception of the impact of skin diseases on different aspects of their QOL over the last week. The items of the DLQI encompass aspects such as symptoms and feelings, daily activities, leisure, work or school, personal relationships, and the side effects of treatment. Each item is scored on a 4-point scale: 0=not at all/not relevant , 1=a little, 2=a lot, and 3=very much. Scores of individual items are added to yield a total score (0-30). A DLQI score of 0 and 1 means no impact ona patient's QOL whereas a score of 2~5, 6~10, 11~20, and 21~30 indicates a small, moderate, large, and an extremely large effect on patient's QOL, respectively.

    Measured: week 52.

  12. Change from baseline in PASI at week 52

    The Psoriasis Area and Severity Index (PASI) is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis.

    Measured: week 52.

  13. Change from baseline in IGA (mod 2011) at week 52

    The modified version of Investigator's Global Assessment (IGA) wich was developed in 2011 (mod 2011) is a simple instrument providing a subjective evaluation of the overall severity of psoriasis. Erythema, induration, and scaling of psoriatic lesions are scored on a 5-point scale ranging from 0 (none) to 4 (severe) as the following:

    0=Clear (e.g., no signs of psoriasis, some post-inflammatory hyperpigmentation may be present) ; 1=Almost clear (e.g., no thickening, normal or pink coloration) ; 2=Mild (e.g., mild thickening, pink to light red coloration) ;3= Moderate (e.g., moderate thickening, dull to bright red) ; 4=Severe (e.g., severe thickening, bright to deep red) .

    Measured: week 52.

  14. Change from baseline in BSA at week 52

    Body Surface Area (BSA) score is an important indicator for calculating the overall skin lesion area of psoriasis. BSA ≈1% refers to the area of the skin lesion as the size of a palm, and the estimation of the skin lesion area in this method can roughly assess the severity of the disease.

    Measured: week 52

  15. Incidence of adverse events

    Number of patients reporting at least one adverse event in the study. An adverse event is defined as any untoward medical occurrence in a clinical trial participant graded according to the common terminology criteria for adverse events (CTCAE) v.5.0 criteria,including clinically-significant changes in physical examinations, laboratory safety tests, ECG and vital signs

    Measured: week 52

  16. Immunogenicity

    Percentage of anti-drug antibody and neutralizing antibody in the study. Subjects with a positive antibody response to CMAB015 or Secukinumab were determined to test neutralizing antibody.

    Measured: week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 May 2024
  2. Study start27 Aug 2024
  3. Primary completion30 Jun 2025
  4. Study completion19 Mar 2026

Resources

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
Model description
Parallel Assignment
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
336 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06398652
Sponsor's protocol ID
CMAB015-002
Status last verified
May 2026
First submitted
1 May 2024
Last updated
7 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing CMAB015 and Secukinumab in people with Psoriasis, run by Taizhou Mabtech Pharmaceutical 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 23 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 7 May 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. 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 patients with PASI 75 at week 12. (time frame: week 12). 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 7 May 2026.

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