Phase 3 Psoriasis Trial, Recruiting NCT06425549 Sponsor: UCB Biopharma SRL Condition: Psoriasis
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Phase 3 Psoriasis Trial, Recruiting

NCT06425549
Recruiting Phase 3

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • The child or teen must be between 6 and 17 years old (inclusive) at the time of signing the consent forms
  • They must have been diagnosed with moderate to severe plaque psoriasis for at least 3 months before the screening visit
  • At both the screening and baseline appointments, psoriasis must cover at least 10% of the body's surface area, have a disease severity score of 3 or higher (out of 4), and have a psoriasis severity score of 12 or higher — or a score of 10 or higher plus psoriasis affecting the face, genitals, or hands and feet in a meaningful way
  • They must be a suitable candidate for systemic psoriasis treatment (medication that works throughout the whole body) and/or light therapy, and eligible for a specific medication called ustekinumab
  • They must weigh at least 15 kg (about 33 lbs) and have a body mass index (a measure of body size) at or above the 5th percentile for their age

Who may not be able to join:

  • Those who tried one or more specific biologic medications targeting IL-17 (such as brodalumab, ixekizumab, or secukinumab) without any improvement within 12 weeks, or who had no response to more than one biologic medication of a different type
  • Those who have a type of psoriasis other than plaque psoriasis (such as guttate, pustular, or erythrodermic), or another skin condition that could make it hard to assess the psoriasis
  • Those who have a history of, or symptoms suggesting, inflammatory bowel disease (a long-term condition causing inflammation in the digestive tract)
  • Those with a history of active tuberculosis (TB) that was not successfully treated, or latent (inactive) TB that was not treated with preventive medication
  • Those who have a current serious infection or a history of serious, long-lasting, or unusual infections
  • Those who have previously received the study drug bimekizumab
  • Those who have previously received ustekinumab
  • Those who have taken certain other medications outside of the allowed timeframes, or are currently taking treatments that are not permitted in this trial (confirm with trial site)
  • Those who currently have active thoughts of suicide or a history of suicidal behaviour
  • Those who have been diagnosed with severe depression in the 6 months before the screening visit
  • Those who have been admitted to a psychiatric hospital within the past year before joining the study

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 27 July 2026
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: UCB Cares, 001 844 599 2273

Phone: 1-844-599-2273 (USA)

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 3
Sponsor
UCB Biopharma SRL
Registry
ClinicalTrials.gov
Start date
25 June 2024
Est. completion
21 August 2028

Where this trial is recruiting

🇧🇪 Belgium 🇨🇦 Canada 🇨🇿 Czechia 🇫🇷 France 🇩🇪 Germany 🇭🇺 Hungary 🇮🇹 Italy 🇯🇵 Japan 🇵🇱 Poland 🇪🇸 Spain 🇺🇸 United States

Primary endpoints

Psoriasis Area Severity Index 90 (PASI90) response at Week 16; Investigator´s Global Assessment (IGA) 0/1 response at Week 16

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 27 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov