New drug bimekizumab shows promise for psoriasis in early trial
NCT ID NCT03025542
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This Phase 2 trial tested the drug bimekizumab in 49 adults with moderate to severe plaque psoriasis. Participants received either bimekizumab or a placebo, and researchers measured how well the drug cleared skin and how long it stayed in the body. The goal was to see if bimekizumab could be a safe and effective treatment for this chronic skin condition.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- bimekizumab
- What this could lead to
- If successful, this could lead to a new treatment option for people with moderate to severe plaque psoriasis, helping to clear skin and reduce symptoms.
- What could go wrong
- This was a small, early-phase study (Phase 2) with only 49 participants. Larger trials are needed to confirm safety and effectiveness. Some participants may still experience side effects.
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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
49 people
The number who actually took part.
- Started
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Dec 2016
- Finished
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Dec 2017
- 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 70 years
- Sex
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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 Hide 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: * Male or female at least 18 years of age and less than or equal to 70 * Chronic plaque psoriasis for at least 6 months prior to Screening * Psoriasis Area and Severity Index (PASI) \>=12 and body surface area (BSA) \>=10% and Investigator's Global Assessment (IGA) score \>=3 on a 5-point scale * Candidates for systemic psoriasis therapy and/or phototherapy and/or chemophototherapy * Female subjects must be postmenopausal, permanently sterilized or, if of childbearing potential, must be willing to use a highly effective method of contraception up till 20 weeks after last administration of study drug, and have a negative pregnancy test at Visit 1 (Screening) and immediately prior to first dose * Male subjects with a partner of childbearing potential must be willing to use a condom when sexually active, up till 20 weeks after the last administration of study medication (anticipated 5 half-lives) Exclusion Criteria: * Subjects previously participating in a bimekizumab study * Subjects with erythrodermic, guttate, pustular form of psoriasis, or drug-induced psoriasis * History of chronic or recurrent infections, or a serious or life-threatening infection within the 6 months prior to the Baseline Visit (including herpes zoster) * High risk of infection in the Investigator's opinion * Current sign or symptom that may indicate an active infection * Concurrent acute or chronic viral hepatitis B or C or human immunodeficiency virus (HIV) infection * Live (includes attenuated) vaccination within the 8 weeks prior to Baseline * Subjects with concurrent malignancy or history of malignancy during the past 5 years (except for specific malignant condition as defined in the protocol) * Primary immunosuppressive conditions * TB infection, high risk of acquiring TB infection, latent TB infection (LTBI), or current or history of NTMB infection * Laboratory abnormalities, as defined in the study protocol * Any condition which, in the Investigator's judgement, would make the subject unsuitable for inclusion in the study * Exposure to more than 1 biological response modifier (limited to anti-TNF or IL-12/-23) or any biologic response modifier during the three months prior to the Baseline Visit * Subjects have received previous treatment with any anti-IL-17 therapy for the treatment of psoriasis or psoriatic arthritis * Subjects with a diagnosis of inflammatory conditions other than psoriasis or psoriatic arthritis, including but not limited to rheumatoid arthritis, sarcoidosis, or systemic lupus erythematosus. Subjects with a diagnosis of Crohn's disease or ulcerative colitis are allowed as long as they have no active symptomatic disease at Screening or Baseline * Subjects taking psoriatic arthritis medications other than nonsteroidal anti-inflammatory drugs (NSAIDs) or analgesics
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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
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Ps0016 101
Melbourne, Australia
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Ps0016 102
Kogarah, Australia
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Ps0016 104
Woolloongabba, Australia
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Ps0016 201
Ajax, Canada
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Ps0016 202
Windsor, Canada
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Ps0016 203
London, Canada
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Ps0016 501
Chisinau, Moldova
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Ps0016 704
Bexley, Ohio, United States
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