Ulcerative Colitis Clinical Trial
Official title:
A Multicenter, Open Phase II Study to Assess the Effect and Safety of "Low Dose" Photodynamic Therapy in Patients With Moderate to Severe Active Distal Ulcerative Colitis
Objectives:
Primary: The primary study objective is to determine a clinical response as assessed by the
Mayo score to low dose PDT in patients with moderate to severe active distal UC.
Secondary: The secondary study objectives are to assess the effect on inflammation and the
safety and tolerability of low dose PDT in patients with moderate to severe active distal
UC.
This is a multicenter, open phase II study that will enroll a maximum of 20 eligible
patients with moderate to severe active distal UC. The first 10 eligible patients, the first
cohort, will receive PDT at a 10 Joule per square centimetre (J/cm2) dose intensity. If no
clinical response is observed in the first 7 eligible patients, the study will be stopped
due to lack of efficacy. If at least 1 clinical response is observed in the first 7
patients, the first cohort will be completed to a total of 10 eligible patients
- Trial with medicinal product
Subsequently, the following algorithm will apply:
- >3 clinical responders at SD8, then another 10 patients, the second cohort, will be
exposed to the same PDT dose intensity
- <3 clinical responders, without adverse proctosigmoidoscopic observations at SD8, then
the second cohort, will be exposed to the next higher PDT dose intensity 15 J/cm2
- <3 clinical responders, with adverse proctosigmoidoscopic observations at SD8, then the
second cohort, will be exposed to the next lower PDT dose intensity 5 J/cm2
- The safety will be continuously evaluated throughout the study.
The screening phase consists of 1 week (SD-7 - SD0), the treatment phase of 4 weeks
(SD1-SD29), and the follow-up evaluation phase of 4 weeks (SD30-SD57), equating to an
overall duration of 9 weeks per patient. It is foreseen to have at least 3 participating
investigational sites to complete accrual of the first cohort in 3 months, and the second
cohort, if appropriate in an additional 3 months. In case of low recruitment, extra sites
will be asked for participation. Hence the study duration from study initiation until last
patient whom completed the study is 8 months to reach the primary analysis of the study. The
follow-up analysis will be completed about 3 months later.
Stopping rules:
Requirement for prohibited medication or surgical procedure Requirement to increase the dose
of permitted medication SAE thought to be attributable to PDT Grade III and IV toxicities
(CTC v3.0) thought to be attributable to PDT Patients request to be withdrawn Lost to
follow-up
Investigational Medicinal Device:
All patients will drink 50 ml orange juice containing 15 mg/kg 5-aminolevulinic acid
(5-ALA). After 3 hours, the lesions will be illuminated with red light at 635 nm using a
cylindrical light diffuser (Model RD, Medlight SA) in a white diffusing inflatable balloon
catheter (model CDB OEB, Medlight SA) at a fluence rate of 65.5 mW/cm2 over 153 seconds
resulting in a total light dose of 10 J/cm2. The first cohort will be treated at a ligh
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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