Phase 3 Psoriasis Trial, Terminated NCT01708603 Sponsor: Bausch Health Americas, Inc. Condition: Psoriasis
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Trial results

AI generated results 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

According to the results reported on ClinicalTrials.gov, this trial looked at a skin condition called moderate to severe plaque psoriasis. It enrolled 1,831 participants across four groups: 612 people received brodalumab at a 210 mg dose, 610 received brodalumab at a 140 mg dose, 300 received ustekinumab (another existing treatment used for comparison), and 309 received a placebo (an inactive injection). The trial measured three things at the 12-week mark: a doctor's overall impression of the skin (called the sPGA score), the proportion of participants whose psoriasis area and severity improved by at least 75% (PASI 75), and the proportion whose psoriasis cleared completely (PASI 100). The reported data shows the following participant counts meeting each measure at week 12. For the doctor's overall skin assessment (sPGA), the numbers recorded as "clear or almost clear" were: 481 out of 612 in the 210 mg brodalumab group, 354 out of 610 in the 140 mg brodalumab group, 183 out of 300 in the ustekinumab group, and 12 out of 309 in the placebo group. For the 75% improvement measure (PASI 75), the reported numbers were 528, 406, 210, and 25 respectively across the same groups. For complete clearance (PASI 100), the reported numbers were 272, 157, 65, and 2 respectively. The data does not include the percentage figures themselves, only the raw participant counts. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.

Phase 3 Psoriasis Trial, Terminated

NCT01708603
Terminated Phase 3 🇦🇺 Australian site

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:

  • You have had moderate to severe plaque psoriasis that has been stable for at least 6 months.
  • At the screening and start of the trial, your psoriasis affects at least 10% of your body surface area and scores highly enough on two standard psoriasis severity measurement scales (confirm with trial site for exact score details).

Who may not be able to join:

  • You have been diagnosed with a specific type of psoriasis other than plaque psoriasis (such as pustular, guttate, or erythrodermic psoriasis), psoriasis caused by medication, or another skin condition like eczema that could affect study results.
  • You have a known history of Crohn's disease.
  • You have another significant ongoing medical condition or abnormal lab results, as outlined in the study rules (confirm with trial site).
  • You have not stopped using certain psoriasis treatments within the required timeframe before joining (confirm with trial site for which treatments and how long before).
  • You have previously been treated with ustekinumab or any anti-IL-17 biologic therapy (a specific type of medication that targets the immune system).
  • You are currently pregnant, breastfeeding, or planning to become pregnant during the study.
  • You are a woman who is unwilling to use highly effective contraception, unless you have been through menopause for at least 2 years or have had a surgical procedure that prevents pregnancy.

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: MD, Amgen

Australian sites

Research Site, Phillip, Australian Capital Territory
Research Site, Kogarah, New South Wales
Research Site, Benowa, Queensland
Research Site, Gold Coast, Queensland
Research Site, Woolloongabba, Queensland
Research Site, Box Hill, Victoria
Research Site, Carlton, Victoria
Research Site, Parkville, Victoria

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
Terminated
Phase
Phase 3
Sponsor
Bausch Health Americas, Inc.
Registry
ClinicalTrials.gov
Start date
1 August 2012
Est. completion
1 September 2014

Where this trial is recruiting

🇦🇺 Australia 🇦🇹 Austria 🇨🇦 Canada 🇨🇿 Czechia 🇫🇷 France 🇭🇺 Hungary 🇳🇱 Netherlands 🇵🇱 Poland 🇵🇹 Portugal 🇪🇸 Spain 🇺🇸 United States

8 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

Percentage of Participants With Static Physician Global Assessment (sPGA) Score Success (Score of 0 or 1) at Week 12; Percentage of Participants With Psoriasis Area Severity Index (PASI) 75 at Week 12; Percentage of Participants With Psoriasis Area Severity Index (PASI) 100 at Week 12

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