New psoriasis drug matches leading biologic in Head-to-Head trial

NCT ID NCT06398652

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 3 trial tested whether a new biologic called CMAB015 works as well as secukinumab (Cosentyx) for moderate-to-severe plaque psoriasis. 336 adults received either drug for up to 48 weeks. The main goal was to see if at least 75% of skin symptoms improved by week 12. The study is now complete, but results have not yet been shared.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
CMAB015 (a biologic similar to secukinumab)
What this could lead to
If CMAB015 works as well as secukinumab, it could offer a more affordable or accessible treatment option for people with moderate-to-severe psoriasis.
What could go wrong
This is a comparison study, not a test of a new cure. Even if CMAB015 is similar, it may not be approved or may have different side effects. The results are not yet published.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

336 people

The number who actually took part.

Started

Aug 2024

Finished

Mar 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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. Exclusion Criteria: * 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. * 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.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Psoriasis are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Huashan Hospital

    Shanghai, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.