HF2 Therapy in the Treatment of Active Ulcerative Colitis

Summary

Participation Requirements

Description

1.1 Objective: To investigate the efficacy and safety of HF2 to induce remission in patients with active UC. 1.2 Methods: This will be a two-stage study: Stage 1 will comprise an open label single arm exploratory study of 10 active UC patients investigating HF2 therapy for induction of remission in ...

1.1 Objective: To investigate the efficacy and safety of HF2 to induce remission in patients with active UC. 1.2 Methods: This will be a two-stage study: Stage 1 will comprise an open label single arm exploratory study of 10 active UC patients investigating HF2 therapy for induction of remission in outpatients with active UC. Stage 2: If clinical response is achieved in ? 3 patients and no significant safety signals will emerge, the investigators will proceed to a prospective pilot randomized placebo-controlled study. Stage 1: Open label study 1.7 Primary outcome stage I The primary outcome will be the percentage of patients in clinical remission (SCCAI score of ?2) at week 4 after initiation of therapy Secondary outcomes (phase 1): 1.7.1 The percentage of patients who had a rapid clinical response at day 7 after induction of therapy 1.7.2 The percentage of patients who had a clinical response at week 4 after initiation of therapy 1.7.3 Improvement in endoscopic score at week 4 compared to baseline according to modified endoscopic Mayo score (improvement of ? 1 point) 1.7.4 Achievement of mucosal healing (endoscopic modified Mayo score of ?1). 1.7.5 Percentage of patients who achieve normalization and/or >50% improvement in C-reactive protein (CRP) and/or calprotectin levels (computed out of patients with abnormal values at baseline for these indices). 1.7.6 Time-to-response defined as number of days to achieve a drop of ?3 points of the SCCAI score. 1.7.7. Time-to-ceasing of bleeding, defined as number of days for complete absence of blood in stools (SCCAI bleeding sub-score of 0), in those patients who has at least some blood in stool at entry (SCCAI bleeding sub-score of 1 or more). 1.7.8 The percentage of patients in clinical remission at day 7 after induction of therapy. 1.7.9. Improvement in IBD quality of life as gauged by questionnaire (IBDQ). 2 Intervention: Patients diagnosed with active UC will receive HF2 therapy for 4 weeks. 3 Procedures: 3.2 At inclusion: clinical and endoscopic assessment, blood and stool tests, cardiac echo and liver ultrasonography 3.4 clinical and endoscopic assessment, blood and stool tests, cardiac echo and liver ultrasonography Stage II: A multicenter randomized placebo controlled trial. The study will be performed in Sheba Medical Center and up to 2 additional European centers (TBD). For this stage of the trial , the patients will received HF2 combintation or similar (as described above) (2:1 allocation) for 8 weeks. After completion of 8 weeks, all responders previously on active drug will receive additional 8 weeks of oral curcumin or placebo as per original arm. Primary outcome: a composite outcome of clinical response (reduction in SCCAI of ?3 OR achievement of clinical remiision defined as SCCAI ?2) coupled with an objective evidence of response ( Mayo score improvement of ?1 or 50% FcAL reduction ) at week 8 Secondary outcomes: Percentage of patients in clinical remission (SCCAI?2) at week 8 The percentage of patients who had a clinical response at week 8 after initiation of therapy Improvement in endoscopic score at week 8 compared to baseline according to endoscopic Mayo score (improvement of ? 1 point) Achievement of mucosal healing (endoscopic modified Mayo score of ?1) at week 8 Percentage of patients who achieve normalization and/or >50% improvement of CRP and/or calprotectin levels (computed out of patients with abnormal values at baseline for these indices) at week 8. Percentage of patients in corticosteroid-free clinical remission at week 8 Improvement in IBD quality of life as gauged by questionnaire (IBDQ). Percentage of patients in clinical remission at week 16 Percentage of patients with clinical response at week 16 Percentage of patients with normalized fecal calprotectin and CRP 6.2. Intervention: Patients will be randomized into one of two arms: HF2 or placebo formulation (2:1 proportion) for 8 weeks. Following the first 8 weeks, responders w ill receive an additional 8 weeks of curcumin 1.5 g/d or placebo (as per original arm). Patients will undergo clinical, laboratory (CRP, biomarkers, blood chemistry, CBC_biomarker (CRP and fecal calprotectin, at week 0,4,8 and 16 , and endoscopic assessment at baseline and week 8. Cardiac echo and liver US will be performed at week 0 and 8. Corticosteroid tapering will be allowed as per treating physician's discretion after week 8.

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