Phase 2 Uveitis Trial, Completed NCT00866359 Sponsor: Amgen Condition: Uveitis
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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 enrolled 111 adults in total — 56 were assigned to receive a placebo (an inactive tablet) twice daily, and 55 were assigned to receive apremilast 30 mg twice daily. The trial was studying Behçet's syndrome, a condition that can cause painful sores in the mouth and on the genitals. The main thing the trial set out to measure was the number of oral (mouth) ulcers each person had at Day 85 (roughly 12 weeks into treatment). After this first phase, participants who had been on placebo were switched to apremilast for a further 12-week extension phase, and then all participants were followed up observationally. The reported data shows that at Day 85, people in the placebo group had an average of 2.0 mouth ulcers, while people in the apremilast group had an average of 0.4 mouth ulcers. For pain from mouth ulcers, participants rated their pain on a scale of 0 to 100 (where 0 means no pain and 100 means the worst pain imaginable) — the placebo group reported an average score of 36.7, compared with 9.9 in the apremilast group. The trial also tracked ulcer counts over the entire 85-day period (using a running total measure called "area under the curve"): the placebo group's total was reported as 157.82, compared with 67.74 for the apremilast group. Regarding genital ulcer pain scores and genital ulcer counts over time, the reported data shows these were not analysed or the results were not submitted. A separate measure noted that 100% of participants in the apremilast group were free of active genital ulcers at Day 85, compared with 50% in the placebo group. 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 2 Uveitis Trial, Completed

NCT00866359
Completed Phase 2

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 been diagnosed with Behçet Disease, confirmed using internationally recognised diagnostic criteria
  • You have had 2 or more mouth ulcers in the 28 days before your screening appointment (whether or not you are currently being treated)
  • You have 2 or more mouth ulcers present at the time of your baseline appointment
  • Your blood test results meet certain required levels for red blood cells, white blood cells, platelets, kidney function, and liver function (confirm with trial site for your specific results)
  • If you are a woman who could become pregnant, you must have a negative pregnancy test and agree to use two forms of contraception throughout the study
  • If you are a man, you must agree to use a latex condom during any sexual activity that could result in pregnancy during the study

Who may not be able to join:

  • You are currently pregnant or breastfeeding
  • You have any condition that the medical team believes puts you at risk (confirm with trial site)
  • You currently have a fungal infection affecting your whole body
  • You have had a tuberculosis (TB) infection within the last 3 years
  • You have a history of frequent recurring bacterial infections
  • You have tested positive for tuberculosis on a skin test, or have a history of tuberculosis that was not fully treated
  • You had an abnormal chest X-ray or abnormal heart tracing (ECG) at your screening appointment
  • You have a history of HIV infection
  • You have a condition, either from birth or developed later, that weakens your immune system
  • You tested positive for Hepatitis B or Hepatitis C at your screening appointment
  • You have a history of cancer (except for a type of skin cancer called basal-cell carcinoma that was fully treated more than 3 years ago)
  • You currently have Behçet Disease seriously affecting a major organ
  • You are currently using medicines that affect your immune system, or steroid creams/ointments, including eye drops containing steroids
  • You have taken part in another clinical trial or used an experimental medication within 4 weeks before your baseline appointment (or longer, depending on the medication — confirm with trial site)

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 28 July 2026
Phase 2: approximately ~30% 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.

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Trial details

Status
Completed
Phase
Phase 2
Sponsor
Registry
ClinicalTrials.gov
Start date
1 August 2009
Est. completion
1 May 2012

Where this trial is recruiting

Turkey (Türkiye) 🇺🇸 United States

Primary endpoints

Number of Oral Ulcers at Day 85

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: 28 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