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Crohn DiseasePhase 2NCT02209792

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

A Phase 2 study testing BIBR 796 BS, 5 mg and BIBR 796 BS, 20 mg in people with Crohn Disease, run by Boehringer Ingelheim.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Crohn Disease
What is being tested?
BIBR 796 BS, 5 mg and BIBR 796 BS, 20 mg
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
284 participants
Where
No sites listed yet
Study dates
Oct 2001to Jan 2004
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 15Show fewer
  • 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)
  • 5-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
  • 6-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

Who cannot join

  • 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
Show all 45Show fewer
  • 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
  • Treatment with anti-inflammatory medication deviating from the criteria for dosage, and stability as provided in the inclusion criteria
  • Patients treated with any of the following therapy:
  • antibiotics provided the dosage had not been stable within 2 weeks prior to visit 2;
  • parenteral or elemental diet;
  • intrarectal therapy for Crohn's disease 2 weeks prior to visit 2 (added by amendment 1, dated 16 January 2002)
  • Treatment with:
  • Nonsteroidal anti-inflammatory drugs (NSAIDs) within 2 weeks prior to visit 2;
  • Acetylsalicylic acid >100 mg/d;
  • Paracetamol (acetaminophen) >3 g/day;
  • Drug classified as proton pump inhibitor: 7 days prior to visit 2. This exclusion criterion was deleted after amendment 2 dated 11 June 2002.
  • Drug classified as H2-receptor-blocker or antacid: 2 days prior to visit 2. This exclusion criterion was deleted after amendment 2 dated 11 June 2002.
  • Active infection or serious infectious diseases resulting in hospitalisation or requiring systemic anti-infective therapy within 4 weeks before visit 2
  • Serologic evidence of active hepatitis B and/or C
  • Known HIV-infection
  • History of prior tuberculosis infection or suspicion of active infection at screening based on chest X-ray done within 6 months prior to treatment phase
  • History of cardiovascular, renal, neurologic, psychiatric, liver, immunologic, or endocrine dysfunction if they were clinically significant. A clinically significant disease was defined as one which, in the opinion of the investigator, may have either put the patient at risk because of participation in the study or as a disease which may have influenced the results of the study or the patient's ability to participate in the study
  • Recent history of heart failure (one year or less) or myocardial infarction or patients with any cardiac arrhythmia requiring drug therapy (changed by amendment 1, dated 16 January 2002)
  • ECG results outside of the reference range of clinical relevance including, but not limited to QTcB >480 msec, PR interval >240 msec, QRS interval >110 msec
  • History of malignant disease in the last 5 years or suspicion of active malignant disease except successfully treated squamous or basal cell carcinoma of the skin and except patients with cervical carcinoma in situ who have had adequate treatment and follow up
  • Clinically significant abnormal baseline haematology, blood chemistry or urinalysis if the abnormality defines a disease listed as an exclusion criterion
  • Any of the following specific laboratory abnormalities at visit 1:
  • alanine aminotransferase (ALT), aspartate aminotransferase (AST) greater than upper limit of normal range (ULN)
  • Total bilirubin greater than ULN except for patients with documented Gilbert's disease
  • Gamma-glutamyltransferase, alkaline phosphatase or lactate dehydrogenase greater than 1.5 x ULN
  • White blood cell count greater than 1.5 ULN which was not due to Crohn's disease as assessed by the investigator
  • Serum creatinine above 1.5 x ULN
  • History of drug or alcohol abuse within the past two years or active drug or alcohol abuse
  • Participation in another clinical trial within 4 weeks or 5 half-lives of the respective investigational agent, whichever was longer
  • Hypersensitivity to trial drug
  • Inability to comply with the protocol

About this study

Official title: A Randomised, Double-blind, Placebo-controlled, Five* Parallel Groups, Dose Finding Study of BIRB 796 BS (10, 20, 30, and 60 mg*) Administered Twice a Day Orally Over 8 Weeks in Patients With Moderate to Severe Crohn's Disease Followed by a 18 Weeks Treatment Extension in Patients With Clinical Remission or Clinical Response After 8 Weeks Treatment With the Respective Dose of BIRB 796 BS - Extension Phase. * Subsequent to Amendment 4 (Dated 11 Jun 2002) a 60 mg b.i.d. Group Was Included.

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
Being tested
Placebo, BIBR 796 BS, 5 mg, BIBR 796 BS, 20 mg
Medical subject headings
Crohn Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PlaceboDrug

  • BIBR 796 BS, 5 mgDrug

  • BIBR 796 BS, 20 mgDrug

Study groups in NCT02209792
Study groupRoleWhat they receive
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo
BIRB 796 BS, low doseExperimental2 x 5 mg b.i.d.
Receives: Drug: Placebo; Drug: BIBR 796 BS, 5 mg
BIRB 796 BS, medium dose 1Experimental20 mg b.i.d.
Receives: Drug: Placebo; Drug: BIBR 796 BS, 20 mg
BIRB 796 BS, medium dose 2Experimental2 x 5 mg + 20 mg b.i.d.
Receives: Drug: BIBR 796 BS, 5 mg; Drug: BIBR 796 BS, 20 mg
BIRB 796 BS, high doseExperimental3 x 20 mg b.i.d.
Receives: Drug: BIBR 796 BS, 20 mg

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: at week 8

Secondary outcomes (22)

  1. Clinical remission (defined as a CDAI score below 150)

    Measured: at week 26

  2. Stabilised clinical remission at the end of the main treatment phase

    Measured: at week 8 and 10

  3. Time to clinical remission

    Measured: up to 26 weeks

  4. Duration of maintenance of clinical remission

    Measured: up to 26 weeks

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

    Measured: up to 26 weeks

  6. Time to clinical response

    Measured: up to 26 weeks

  7. Duration of maintenance of clinical response

    Measured: up to 26 weeks

  8. Changes from baseline in the CDAI score

    Measured: up to 26 weeks

  9. Changes from baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) score

    Measured: up to 26 weeks

  10. Number of patients with 50% fistulae reduction

    defined as an at least 50% reduction from baseline in the number of draining fistulae

    Measured: up to 26 weeks

  11. Changes from baseline in the number of draining fistulae

    Measured: up to 26 weeks

  12. Changes from baseline in C-reactive protein (CRP) measurements

    Measured: up to 26 weeks

  13. Changes from baseline in the daily corticosteroid dose

    measured in mg prednisone equivalent

    Measured: after week 10

  14. Number of drop-outs due to treatment failure

    Measured: up to 26 weeks

  15. Number of patients with adverse events

    Measured: up to 40 weeks

  16. Number of patients with clinically relevant changes in laboratory parameters

    Measured: up to week 38

  17. Number of patients with relevant findings in electrocardiogram (ECG)

    Measured: up to 26 weeks

  18. Extended clinical response (defined as a reduction of CDAI score ≥ 100)

    Measured: week 10 to 26

  19. Time to extended clinical response

    Measured: week 10 to 26

  20. Duration of maintenance of extended clinical response

    Measured: week 10 to 26

  21. Changes from baseline in the Crohn's Disease Endoscopic Index of Severity (CDEIS) score

    for patients in the endoscopic substudy only

    Measured: at the end of week 8

  22. Changes from baseline in the histological scoring of biopsy specimens

    for patients in the endoscopic substudy only

    Measured: at the end of week 8

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Aug 2014 (estimated)
  2. Study startOct 2001
  3. Primary completionJan 2004

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
284 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02209792
Sponsor's protocol ID
1175.12
Status last verified
Aug 2014
First submitted
5 Aug 2014
Last updated
6 Aug 2014
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BIBR 796 BS, 5 mg and BIBR 796 BS, 20 mg in people with Crohn Disease, run by Boehringer Ingelheim.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 45 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 6 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early. Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical Remission defined as Crohn's Disease Activity Index (CDAI) < 150 (time frame: at week 8). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02209792.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2014.

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