A Three-Arm, Randomized, Placebo-Controlled, Double-Blind Phase 3 Study to Evaluate the Safety and Efficacy of Once-Daily and Twice-Daily Dosing of a Novel Hydrocortisone Acetate 90 mg Suppository Formulation Administered with the Sephure® Suppository Applicator in Subjects with Ulcerative Colitis of the Rectum.

A Three-Arm, Randomized, Placebo-Controlled, Double-Blind Phase 3 Study to Evaluate the Safety and Efficacy of Once-Daily and Twice-Daily Dosing of a Novel Hydrocortisone Acetate 90 mg Suppository Formulation Administered with the Sephure® Suppository Applicator in Subjects with Ulcerative Colitis of the Rectum. - cessa

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-003596-19-RO

Enrollment

618

Registered

2022-04-21

Start date

2021-07-07

Completion date

Unknown

Last updated

2025-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ulcerative Colitis of the Rectum MedDRA version: 20.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.0 Level: PT Classification code 10009900 Term: Colitis ulcerative System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.0 Level: HLT Classification code 10027682 Term: Immune and associated conditions NEC System Organ Class: 10021428 - Immune system disorders MedDRA version: 2

Interventions

Product Name: 90 mg hydrocortisone acetate suppository with Sephure suppository applicator Pharmaceutical Form: Suppository INN or Proposed INN: HYDROCORTISONE ACETATE Current Sponsor code: hydrocorti

Eligibility

Sex/Gender

All

Inclusion criteria

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. 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 3-8. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 587 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 31

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the efficacy of two dosage regimens of the study drug (hydrocortisone acetate 90 mg suppository) administered with the Sephure suppository applicator compared to placebo in the treatment of ulcerative colitis (UC) of the rectum using the Modified Mayo Score. ;Secondary Objective: Reduction of stool frequency and rectal bleeding sub-score of 0 (MMDAI) ;Primary end point(s): Primary endpoint is the proportion of subjects with clinical remission at the End of Treatment Visit (Visit 9). Clinical remission is defined as the Modified Mayo Total Score of 0 to 2, with, stool frequency sub-score of 0 or 1 (minimum 1 point decrease from baseline), rectal bleeding sub-score of 0 and endoscopic sub-score of 0 or 1. ;Timepoint(s) of evaluation of this end point: Day 53+3	—

Measure

Time frame

Main Objective: To evaluate the efficacy of two dosage regimens of the study drug (hydrocortisone acetate 90 mg suppository) administered with the Sephure suppository applicator compared to placebo in the treatment of ulcerative colitis (UC) of the rectum using the Modified Mayo Score. ;Secondary Objective: Reduction of stool frequency and rectal bleeding sub-score of 0 (MMDAI) ;Primary end point(s): Primary endpoint is the proportion of subjects with clinical remission at the End of Treatment Visit (Visit 9). Clinical remission is defined as the Modified Mayo Total Score of 0 to 2, with, stool frequency sub-score of 0 or 1 (minimum 1 point decrease from baseline), rectal bleeding sub-score of 0 and endoscopic sub-score of 0 or 1. ;Timepoint(s) of evaluation of this end point: Day 53+3

—

Secondary

Measure	Time frame
Secondary end point(s): Reduction of stool frequency defined as a reported score of 0 or 1, with at least a reduction of 1 point from baseline and absence of rectal bleeding (MMDAI sub-score of 0) defined as a reported score of 0. ;Timepoint(s) of evaluation of this end point: Day 15 and Day 29	—

Countries

Bulgaria, Denmark, Germany, Hong Kong, India, Italy, Philippines, Poland, Romania, Russian Federation, Spain, Ukraine, United States

Contacts

Public Contactcessa Information

Cristcot HCA LLC

research@cessa-uc.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026