Clinical trial NCT01882764
Conditions: Ulcerative Colitis
Sponsor: Hutchison Medipharma Limited
Start date: 2013-06-01; Completion date: 2014-10-01
Enrollment: 66 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A study with an 8 week open label phase study followed by a year long placebo controlled maintenance phase in subjects with active mild to moderate ulcerative colitis (UC), with a modified Mayo Score 4-10 and an endoscopy subscore of 2-3, taking mesalamine (or equivalent) as a concomitant medication. Subjects are required to be in clinical remission or clinical response to enter the year long maintenance phase. This study will help evaluate if HMPL-004 is effective in subjects maintaining clinical remission following successful induction therapy achieving clinical remission or clinical response.

Detailed description:
A two-phase multi-center study with an open label 8-week induction phase and a randomized, double-blind, placebo controlled maintenance phase to evaluate the efficacy and safety of HMPL-004 for a 52-week maintenance therapy in adults with mild to moderate UC and who have demonstrated a sub-optimal response to mesalamine treatment. The study participants will consist of subjects who have completed either the HMPL-004-03 or HMPL-004-05 induction study, complemented by the enrollment of additional subjects in the open label induction phase who meet the entry criteria of this study. . Subjects entering this maintenance study from one of the HMPL-004 induction studies will have their modified Mayo baseline score from that study as their baseline score for this study. All subjects enrolled in the open label induction phase of the study will be re-evaluated for clinical response and remission after the 8-week open label 2400 mg HMPL-004 treatment period. Clinical responders and remitters will be randomized 2:1 (HMPL-004: placebo) to HMPL-004 1800 mg/day or placebo group for the 52-week maintenance phase of the study.

Arms: arm 1: Subjects qualifying for entry into the Maintenance Phase of the study were randomized to take an oral dose of HMPL-004 (600 mg TID; total dose 1800 mg/day) daily, for 52 weeks.

Those subjects who demonstrated clinical remission or response after completing the HMPL-004-03 Induction Study, or after completing the Open Label Phase of this study, were eligible for enrollment in the Maintenance Phase of this study. arm 2: Subjects qualifying for entry into the Maintenance Phase of the study were randomized to take an oral dose of Placebo tablets TID, daily, for 52 weeks.

Those subjects who demonstrated clinical remission or response after completing the HMPL-004-03 Induction Study, or after completing the Open Label Phase of this study, were eligible for enrollment in the Maintenance Phase of this study.
Interventions: intervention 1: HMPL-004 intervention 2: Placebo
Intervention descriptions: intervention 1: Remitters and responders from HMPL-004 Induction study and patients complete the 8-week Open Label Induction Phase will be given HMPL-004 orally three times per day with total daily dose of 1800 mg for 52 weeks. intervention 2: Remitters and responders from HMPL-004 Induction study and patients complete the 8-week Open Label Induction Phase will be given Placebo orally three times per day with total daily dose of 1800 mg for 52 weeks.

Protocol documents: