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Completed

NCT Number: NCT03412682

To Evaluate the Efficacy and Safety of FE 999315 in Japanese Subjects With Mild to Moderate Active Ulcerative Colitis

To demonstrate non-inferiority in efficacy of FE 999315 to mesalazine in patients with mild to moderate active ulcerative colitis after 8 weeks of treatment.

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Key information

Conditions

Colitis, Ulcerative Colitis Colonic Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

16 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Ferring Investigator Site JPN27, Nagoya, Aichi-ken, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male and female patients, 16 to 75 years old, diagnosed with ulcerative colitis.
  • Diagnosis of ulcerative colitis in active phase of mild to moderate entity.
  • Female patients must fulfill at least one of the following criteria: Post-menopausal (women ≥45 years with no menstrual period for at least 12 months without an alternative medical cause), surgically sterile, using a medically approved contraception throughout the trial period or her male partner using medically approved contraception throughout the trial period.
  • Male patients must agree to use medically approved contraception throughout the trial period.

Exclusion criteria

  • Patients with limited distal proctitis.
  • Patients with infectious colitis.
  • Patients with history of colectomy.
  • Patients with severe diseases in other organs and systems.
  • Evidence or history of toxic megacolon.
  • Women who wish to become pregnant during the trial period

Treatment and study plan

Budesonide (6 mg)

Drug

Budesonide (6 mg) administered once a day along with three mesalazine placebo three times a day, over an 8-week treatment period.

Other names: FE 999315

Budesonide (9 mg)

Drug

Budesonide (9 mg) administered once a day along with three mesalazine placebo three times a day, over an 8-week treatment period.

Other names: FE 999315

Mesalazine (3,600 mg)

Drug

Mesalazine (3,600 mg) administered once a day plus three mesalazine 400 mg three times a day, over an 8-week treatment period.

Primary outcomes

  1. Change from baseline of total Ulcerative Colitis Disease Activity Index (UCDAI) scores after 8 weeks of treatment using the mucosal appearance score

    Time frame: After 8 weeks

    UCDAI is a four-component scale, used to determine the severity of ulcerative colitis. The four components assessed are stool frequency, rectal bleeding, mucosal appearance and physician's rating of disease activity. Score for each component can range between 0-3 and thus, the maximum overall score can be between 0-12. Higher score implies higher disease severity.

Secondary outcomes

  1. Percentage of subjects achieving clinical remission after 8 weeks of treatment

    Time frame: 8 weeks

  2. Percentage of subjects achieving 0 score for subscores of rectal bleeding, stool frequency and mucosal appearance (normal mucosa) in UCDAI after 8 weeks of treatment

    Time frame: 8 weeks

  3. Percentage of subjects achieving clinical improvement after 8 weeks of treatment

    Time frame: 8 weeks

  4. Percentage of subjects achieving endoscopic improvement after 8 weeks of treatment for subjects with baseline UCDAI mucosal appearance subscore greater than equal to [≥]1

    Time frame: 8 weeks

  5. Percentage of subjects achieving symptom resolution after 2 weeks of treatment

    Time frame: 2 weeks

  6. Percentage of subjects achieving symptom resolution after 4 weeks of treatment

    Time frame: 4 weeks

  7. Percentage of subjects achieving symptom resolution after 8 weeks of treatment

    Time frame: 8 weeks

  8. Percentage of subjects with endoscopic healing after 8 weeks of treatment

    Time frame: 8 weeks

  9. Change from baseline in partial UCDAI score at 2 weeks

    Time frame: 2 weeks

  10. Change from baseline in partial UCDAI score at 4 weeks

    Time frame: 4 weeks

  11. Change from baseline in partial UCDAI score at 8 weeks

    Time frame: 8 weeks

Sponsors and collaborators

Lead sponsor

Ferring Pharmaceuticals

Industry

Registry information

Official study title

A Phase 3, Multi-centre, Randomised, Double-blind, Active-controlled, Parallel-group Trial Investigating the Efficacy and Safety of FE 999315 Following 8 Weeks of Treatment for Mild to Moderate Active Ulcerative Colitis in Japanese Subjects

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jan 26, 2018
Registry last updated
Jun 18, 2020

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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