Phase 3 Study to Evaluate the Safety and Efficacy of Hydrocortisone Acetate Suppositories

Cristcot

Status and phase: Completed; Phase 3

Conditions: Ulcerative Proctitis

Treatments: Combination Product: Twice daily 90 mg hydrocortisone acetate suppository administered with Sephure applicator; Combination Product: Twice daily placebo suppository administered with Sephure applicator; Combination Product: Once daily 90 mg hydrocortisone acetate or placebo suppository administered with Sephure applicator

Study type: Interventional

Funder types: Industry

Identifiers

NCT04469686

CHS1221

2019-003596-19 (EudraCT Number)

Details and patient eligibility

About

A randomized, multi-center, double-blind, three arm placebo-controlled study in male and non-pregnant, non-lactating female subjects aged 18 years to examine the safety and efficacy of two dosing regimens of hydrocortisone acetate 90 mg suppository administered with the Sephure applicator for the treatment of ulcerative colitis of the rectum.

Full description

Hydrocortisone acetate 90 mg or placebo will be administered as a rectal suppository with a Sephure suppository applicator. Two arms of the study will receive different dosage regimens of hydrocortisone acetate, and the third arm will receive placebo. All subjects will administer the study drug twice a day; once in the morning and once in the evening for 28 days.

The study population will consist of male and non pregnant, non lactating females aged 18 years and older with a confirmed diagnosis of active UC of the rectum.

Enrollment: 200 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or non pregnant, non lactating females aged 18 years and older.
• Subjects with a confirmed diagnosis of active UC of the rectum, extending no more than 15 centimeters (cm) (5.9 inches) proximal to the anal verge as assessed by colonoscopy performed at Visit 2. Note: Subjects may have a history of more extensive UC (e.g., pancolitis), but have active disease only in the rectum at the time of enrollment.
• Modified Mayo sub score for stool frequency of 1 3.
• Modified Mayo sub score for rectal bleeding of 0 2.
• Modified Mayo endoscopic sub score of 2 3.
• Total Modified Mayo Score (without physician global assessment) of 4-8.

Exclusion criteria

• History or current diagnosis of bacterial or other infectious colitis, radiation enteritis and radiation proctitis, Crohn's disease, collagenous colitis and indeterminate colitis.
• Prior gastrointestinal surgery except appendectomy, cholecystectomy, and hernia.
• Concomitant active lower gastrointestinal disease (except Irritable Bowel Syndrome) or distortion of intestinal anatomy.
• Bleeding hemorrhoids at the time of enrollment.
• Acute diverticulitis at the time of enrollment.
• Acute or chronic pancreatitis at the time of enrollment.
• Unmanaged celiac disease at the time of enrollment.
• Positive stool test for enteric pathogens, Clostridium difficile, or presence of ova and parasites.
• Taking a prohibited medication.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

200 participants in 3 patient groups, including a placebo group

Twice Daily - Active

Experimental group

Description:

Twice daily 90 mg hydrocortisone acetate suppository administered with Sephure suppository applicator

Treatment:

Combination Product: Twice daily 90 mg hydrocortisone acetate suppository administered with Sephure applicator

Once Daily - Active

Experimental group

Description:

Once daily 90 mg hydrocortisone acetate and once daily placebo suppository administered with Sephure suppository applicator

Treatment:

Combination Product: Once daily 90 mg hydrocortisone acetate or placebo suppository administered with Sephure applicator

Placebo

Placebo Comparator group

Description:

Twice daily placebo suppository administered with Sephure suppository applicator

Treatment:

Combination Product: Twice daily placebo suppository administered with Sephure applicator