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Completed

NCT Number: NCT00741910

Extension Study of Semapimod 60 mg IV x 3 Days

Study CNI-1493-CD06 is an open, single-arm extension studies to CD03 and CD05. CDAI is the only efficacy measure assessed in this study. The safety of multiple courses of semapimod is to be determined by the incidence of clinical and laboratory adverse events.

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Key information

Conditions

Crohn's Disease Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Benjamin Franklin University, Berlin, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

The study was open to patients who had satisfactorily completed either study CNI-1493-CD-03 or CNI-1493-CD-05. Initial entry criteria were:

  • Patients who satisfactorily completed either study CNI-1493-CD-03 or CD-05 were eligible for participation in this study. Satisfactory completion was defined as follows:
  • The patient completed 5 treatment courses in the previous trial.
  • The patient had responded to treatment, as defined by a decrease in CDAI of at least 70 points from original baseline (prior to treatment on study CD-02 or CD-04) at the last assessment for study CD-03 or CD-05, respectively. The decrease had to be attributable to semapimod treatment. Thus, patients whose response was attributable to other anti-Crohn's disease therapy are not to be included.
  • The patient had no adverse event >grade 2 felt to be probably or definitely related to study medication.
  • The patient did not meet any discontinuation criterion in previous trial.
  • Patients had to sign informed consent specifically for this study, in addition to the consents for the previous studies, CNI-1493-CD-02 or CD-03, and CNI-1493-CD-04 or CD-05.
  • Patients could not take any other investigational therapies during the course of this study.
  • Men and women of childbearing potential had to be using a barrier method (diaphragm or condom) of contraception and continue doing so for at least 3 months after last study medication. It was strongly recommended that two forms be used.
  • Patients had to be able to adhere to the study visit schedule and/or protocol requirements.

Exclusion criteria

Could not have met any of the exclusion criteria for the CD02, 03, 04 or 05 studies.

Treatment and study plan

Semapimod

Drug

semapimod IV 60 mg x 3 days q 6 - 10 weeks

Other names: CNI-1493

Primary outcomes

  1. Crohn's Disease Activity Index (CDAI)

    Time frame: Every 6 - 10 weeks

Secondary outcomes

  1. Safety

    Time frame: Every 6 - 10 weeks

Sponsors and collaborators

Lead sponsor

Ferring Pharmaceuticals

Industry

Registry information

Official study title

Extension Study of CNI-1493 for Treatment of Moderate to Severe Crohn's Disease

Acronym: CD06

Important dates

Study start
2003
Primary completion
2006
Study completion
2006
First posted
Aug 26, 2008
Registry last updated
Nov 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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