Semapimod for Treatment of Moderate to Severe Crohn's Disease 1 or 3 Days' Treatment Versus Placebo

NCT00739986 | Completed Phase 2

• 1 other identifier: CNI-1493-CD04
• Study Type: interventional
• Target: 152
• Locations: 5 countries
• Sites: 28

Brief Summary

Assessment of the number of days' treatment with semapimod necessary for efficacy, as measured by response rate to CNI-1493 as compared to placebo, in patients with moderate to severe Crohn's disease (CD).

Conditions

Crohn's Disease

Keywords

Crohn's Disease; TNF-alpha; IL-6; MAP Kinase; CNI-1493

Outcome Measures

Primary Outcomes (1)

• Crohn's Disease Activity Index (CDAI) score

  Day 29

Secondary Outcomes (4)

• Inflammatory Bowel Disease Questionnaire (IBDQ)

  Day 29

• Crohn's disease endoscopic index of severity (CDEIS)

  Day 29

• Change in level of C-reactive protein (CRP)

  Day 29

• Safety (Adverse events)

  Days 29 and 57

Study Arms (3)

1

EXPERIMENTAL

Semapimod 60 mg IV x 1 day, placebo IV x 2 days

Drug: Semapimod

2

EXPERIMENTAL

Semapimod 60 mg IV x 3 days

Drug: Semapimod

3

PLACEBO COMPARATOR

Placebo comparator IV x 3 days

Drug: Placebo

Interventions

Semapimod DRUG

semapimod 60 mg IV x 1 day, placebo x 2 days

1

Placebo DRUG

placebo IV x 3 days

3

Eligibility Criteria

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

You may qualify if:

• Men and women at least 18 years of age.
• Baseline Crohn's Disease Activity Index (CDAI) 250-400.
• Crohn's disease of at least 3 months duration, with colitis, ileitis, or ileocolitis, confirmed by radiography and/or endoscopy.
• Those of childbearing potential were to use a barrier method (diaphragm or condom) of contraception and continue doing so for at least 3 months after last study medication. It was recommended that two forms be used.
• Patients receiving medications for CD were to be on each medication for at least 8 weeks prior to screening and on stable doses of each for at least 2 weeks prior to screening, with the following exceptions:
• those on methotrexate had to be on a stable dose for at least 4 weeks and not be receiving more than 25 mg/wk
• those on azathioprine or 6-mercaptopurine on a stable dose for at least 10 weeks
• those on steroids had to have been on steroids for at least 2 weeks and on a stable dose for those 2 weeks. They were not to be receiving more than 20 mg/day prednisone or equivalent
• those on mesalazine had to have been on for at least 6 weeks and on a stable dose for at least 2 weeks
• those on antibiotics for CD had to have been on for at least 2 weeks and on a stable dose for those 2 weeks
• Any CD medication which had been discontinued was to have been discontinued at least 4 weeks prior to screening, with the exception of infliximab, which was to have been discontinued at least 8 weeks prior to screening.
• The screening laboratory tests were to meet the following criteria:
• Hgb \>= 8.5 g/dL (5.3 mmol/L) WBC 3.5-20 x 109/L Neutrophils \>= 1.5 x 109/L Platelets \>= 100 x 109/L ALT (SGPT) \<1.5 x the upper limit of normal range Alkaline phosphatase \<2.5 x the upper limit of normal range Bilirubin \<25 mmol/L (1.5 mg/dl) Creatinine \<110 mol/L (1.2 mg/dl)
• Patients were to be able to adhere to the study visit schedule and/or protocol requirements.
• Patients were to be able to give informed consent and the consent was to be obtained prior to any study specific screening procedures.

You may not qualify if:

• Treatment with any other experimental therapeutics within the last 4 weeks before enrolment.
• Patients who had received anti-TNF therapy, such as infliximab, within 8 weeks of screening for this study. Patients who had received anti-TNF therapy \>8 weeks prior to screening were eligible.
• Patients with any ostomy, extensive bowel resection (e.g., more than 100cm of small bowel, proctocolectomy or colectomy with ileorectal anastomosis). Segmental colectomy was permitted.
• Patients immediately in need of surgery for active gastrointestinal bleeding, peritonitis, intestinal obstruction, or intra-abdominal or pancreatic abscess requiring surgical drainage.
• Patients with known severe fixed symptomatic stenosis of the small or large intestine.
• Evidence at the time of enrolment of bowel obstruction or history within the preceding six months as confirmed by radiography, endoscopy, or surgery.
• Patients with a clinically significant abnormality or granulomata or any other evidence of primary tuberculosis infection on chest X-ray
• Patients with current signs or symptoms of clinically significant hematologic, endocrine, pulmonary, cardiac, neurologic or cerebral disease.
• Patients with previous diagnosis of, or known, malignancies.
• Patients with serious infections, such as hepatitis, HIV, pneumonia or pyelonephritis, within 3 months prior to screening.
• History of opportunistic infections such as herpes zoster within 2 months prior to screening, evidence of active CMV, active Pneumocystis carinii, drug resistant atypical mycobacterium.
• Patients with stool examination positive for enteric pathogens, pathogenic ova or parasites, or Clostridium difficile toxin.
• Women who were pregnant or breast-feeding.
• A psychiatric, addictive, or any disorder that compromises ability to give truly informed consent for participation in this study.
• Patients who had received CNI-1493 in the past.

Sponsors & Collaborators

• Ferring Pharmaceuticals: lead

Study Sites (28)

Institute of Healthcare Assessment

San Diego, California, 92120, United States

Location

University of California, San Francisco

San Francisco, California, 94115, United States

Location

Atlanta Gastroenterology Associates

Atlanta, Georgia, 30342, United States

Location

Advanced Gastroenterology Associates

Suwanee, Georgia, 30024, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

Long Island Clinical Research Associates

Great Neck, New York, 11021, United States

Location

Asher Kornbluth, MD

New York, New York, 10128, United States

Location

Rochester General Hospital

Rochester, New York, 14621, United States

Location

Gastroenterology Associates

Bristol, Tennessee, 37620, United States

Location

Gastroenterology Associates

Kingsport, Tennessee, 37660, United States

Location

Cliniques Universitaires Saint-Luc

Brussels, Belgium

Location

Academic Hospital Gasthuisberg

Leuven, Belgium

Location

Benjamin Franklin University

Berlin, Germany

Location

Medizinischen Hochschule-Hannover

Hanover, Germany

Location

Universitats Klinikum Heidelberg

Heidelberg, Germany

Location

University of Kiel

Kiel, Germany

Location

Gastroenterologische Fachpraxis

Minden, Germany

Location

Stadtisches Krankenhaus Munchen-Bogenhausen

München, Germany

Location

University of Munster

Münster, Germany

Location

Rambam Medical Center

Haifa, Israel

Location

Hadassah Medical Center

Jerusalem, Israel

Location

Shaare Zedek Hospital

Jerusalem, Israel

Location

Tel Aviv Sourasky Medical Center

Tel Aviv, Israel

Location

Chaim Sheba Medical Center

Tel Litwinsky, Israel

Location

Academic Medical Center

Amsterdam, Netherlands

Location

Free University (Vrije Universiteit)

Amsterdam, Netherlands

Location

Academisch Ziekenhuis Maastricht

Maastricht, Netherlands

Location

Erasmus Medical Center

Rotterdam, Netherlands

Location

MeSH Terms

Conditions

Crohn Disease

Interventions

semapimod

Condition Hierarchy (Ancestors)

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

Study Officials

• Daan Hommes, MD

  Academic Medical Center, Netherlands

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2008
• First Posted: August 22, 2008
• Study Start: October 1, 2002
• Primary Completion: June 1, 2004
• Study Completion: August 1, 2004
• Last Updated: November 9, 2023

Record last verified: 2012-08

Locations

US (10); BE (2); DE (7); IL (5); NL (4)