A Study to Investigate the Efficacy of LT-02 in Patients With Mesalazine Refractory Ulcerative Colitis

Lipid Therapeutics

Status and phase: Unknown; Phase 2

Conditions: Large Intestine; Diarrhea; Ulcerative Colitis; Abdominal Pain

Treatments: Drug: LT-02; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01011322

LT-02-UC-01

2008-007952-90 (Registry Identifier)

Details and patient eligibility

About

The participation in this clinical study will last approximately 21 weeks with a 1 week screening period and a 12 weeks treatment duration. If the study doctor finds, that the patients disease has significantly improved he/she will enter a treatment free follow-up period of 8 weeks. In total the study consists of 5 to 6 clinical visits (V1 - V6) and 1 telephone follow-up call.

Enrollment: 156 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Men and women 18 years or older who have given written Informed Consent
• Patients with proven ulcerative colitis
• Active disease course for the last 6 weeks or longer with bloody diarrhea
• Patients with an inadequate response to a treatment with mesalazine or a documented intolerance to mesalazine.

Exclusion criteria

• Infectious colitis, including cytomegalovirus or Clostridium difficile induced colitis,
• Crohn's disease,
• Colitis due to other reasons than ulcerative colitis like known diverticulitis, radiation colitis, ischemic colitis, microscopic colitis, or indeterminate colitis,
• Treatment with other investigational medicinal product within 3 months prior to study entry

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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156 participants in 4 patient groups, including a placebo group

LT-02 Dose 1

Experimental group

Description:

0.2g IMP per dose

Treatment:

Drug: LT-02

LT-02 Dose 2

Experimental group

Description:

0.4g IMP per dose

Treatment:

Drug: LT-02

LT-02 Dose 3

Experimental group

Description:

0.8g IMP per dose

Treatment:

Drug: LT-02

Sugar pill

Placebo Comparator group

Description:

placebo matching to 0g of IMP,

Treatment:

Drug: placebo