Dose Finding Study of BIRB 796 BS in Patients With Moderate to Severe Crohn's Disease

NCT02209792 | Terminated Phase 2

• 1 other identifier: 1175.12
• Study Type: interventional
• Target: 284
• Locations: 0 countries
• Sites: N/A

Brief Summary

The primary objective of this extension study was to obtain long-term safety data for BIRB 796 BS in patients with moderate to severe Crohn's disease after 26 weeks of treatment. Secondary objectives were the evaluation of efficacy of BIRB 796 BS to induce clinical remission and response over 26 weeks of treatment.

Conditions

Crohn Disease

Outcome Measures

Primary Outcomes (1)

• Clinical Remission defined as Crohn's Disease Activity Index (CDAI) < 150

  at week 8

Secondary Outcomes (22)

• Clinical remission (defined as a CDAI score below 150)

  at week 26

• Stabilised clinical remission at the end of the main treatment phase

  at week 8 and 10

• Time to clinical remission

  up to 26 weeks

• Duration of maintenance of clinical remission

  up to 26 weeks

• Clinical response (defined as a reduction of CDAI score ≥70)

  up to 26 weeks

Study Arms (5)

Placebo

PLACEBO COMPARATOR

Drug: Placebo

BIRB 796 BS, low dose

EXPERIMENTAL

2 x 5 mg b.i.d.

Drug: Placebo; Drug: BIBR 796 BS, 5 mg

BIRB 796 BS, medium dose 1

EXPERIMENTAL

20 mg b.i.d.

Drug: Placebo; Drug: BIBR 796 BS, 20 mg

BIRB 796 BS, medium dose 2

EXPERIMENTAL

2 x 5 mg + 20 mg b.i.d.

Drug: BIBR 796 BS, 5 mg; Drug: BIBR 796 BS, 20 mg

BIRB 796 BS, high dose

EXPERIMENTAL

3 x 20 mg b.i.d.

Drug: BIBR 796 BS, 20 mg

Interventions

Placebo DRUG

BIRB 796 BS, low dose; BIRB 796 BS, medium dose 1; Placebo

BIBR 796 BS, 5 mg DRUG

BIRB 796 BS, low dose; BIRB 796 BS, medium dose 2

BIBR 796 BS, 20 mg DRUG

BIRB 796 BS, high dose; BIRB 796 BS, medium dose 1; BIRB 796 BS, medium dose 2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patient of 18 to 65 years of age
• Provision of written informed consent in accordance with Good Clinical Practice and local legislation prior to any study procedures
• Diagnosis of Crohn's disease documented for at least 6 months. Preferably, inflammatory activity of the bowel should be confirmed by endoscopy within the last 3 months
• Moderate to severe Crohn's disease, CDAI ≥220 to ≤450, at baseline (visit 2)
• Any of the following therapy, provided the respective criteria for dosage, duration and stability were satisfied:
• Prednisone or other systemic corticosteroids for at least 12 weeks with a stable oral dosage ≤25 mg/d or equivalent for at least two weeks prior to visit 2
• Budesonide with a stable dose of ≤ 9 mg/d for at least 2 weeks prior to visit 2 (changed by amendment 1, dated 16 January 2002)
• Aminosalicylic Acid drugs/derivatives, provided they were given for 3 months or more and the dosage was stable for at least 4 weeks prior to visit 2
• Mercaptopurine or azathioprine, provided they were taken for 6 months or more and the dosage was stable for at least 12 weeks prior to visit 2
• Methotrexate, provided it was taken for 6 months or more and the dosage was stable and ≤25 mg per week for at least 12 weeks prior to visit 2
• The following patients were included in the 18-week treatment extension:
• Patients who received BIRB 796 BS for 8 weeks and reached:
• Clinical remission (defined as CDAI \<150) after 8 weeks or
• Clinical response (reduction of CDAI ≥70) after 8 weeks
• Patients who were willing to continue with their treatment

You may not qualify if:

• Pregnancy (to be excluded at visit 2 by urine β-human chorion-gonadotropin-test in women of childbearing potential) or breast feeding
• Female patients of childbearing potential (not 6 months post-menopausal or surgically sterilised) not using an approved form of birth control (hormonal contraceptives orally or in depot, intrauterine device)
• Patients without signs of inflammation of the bowel in the initial colonoscopy of the substudy
• Patients with colostomy or ileostomy
• Planned or needed surgery during the conduct of the trial due to Crohn's disease or for active gastrointestinal bleeding, peritonitis, intestinal obstruction, or intra-abdominal or pancreatic abscess requiring surgical drainage
• Known or suggested severe fixed symptomatic stenosis of the small or large intestine
• Severe underlying disease in particular of the GI tract (e.g. irritable bowel syndrome, celiac disease, infectious colitis)
• Patients with pathogens or Clostridium difficile toxin detected in the stool culture in the screening period
• Other infectious, ischemic, or immunological diseases with gastrointestinal involvement
• Patients with short bowel syndrome
• Patients who had had a treatment failure with a tumor necrosis factor (TNF)-blocking agent. Treatment failure was defined as not achieving a clinical response (improvement of ≥70 points in CDAI within 4 weeks) in a clinical trial or - in clinical practice -discontinuation of the TNF-blocking agent due to ineffectiveness (changed according to amendment 1, dated 16 January 2002)
• Treatment with cyclosporine A within 12 weeks prior to visit 2
• Last dose given within the specified time period before visit 2 for the following compounds:
• infliximab (Remicade®): 8 weeks,
• investigational agent: 4 weeks or 5 half-lives, whichever is longer

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2014
• First Posted: August 6, 2014
• Study Start: October 1, 2001
• Primary Completion: January 1, 2004
• Last Updated: August 6, 2014

Record last verified: 2014-08