Trial Outcomes & Findings for Phase 3 Study to Evaluate the Safety and Efficacy of Hydrocortisone Acetate Suppositories (NCT NCT04469686)

Last Updated: 2026-08-06

Results Overview

The primary efficacy endpoint was specified as the between-treatment group (HCA Suppository 90 mg bid versus placebo and HCA Suppository 90 mg qd versus placebo) difference in the proportion of subjects with clinical remission at the End of Treatment visit (Day 29). Clinical remission was defined as a Modified Mayo Total Score of 0 to 2, with stool frequency subscore of 0 or 1 (minimum 1 point decrease from baseline), rectal bleeding subscore of 0, and endoscopic subscore of 0 or 1.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

200 participants

Primary outcome timeframe

29 days

Results posted on

2026-08-06

Participant Flow

Participant milestones

Participant milestones
Measure	Twice Daily - Active Twice daily 90 mg hydrocortisone acetate suppository administered with Sephure suppository applicator	Once Daily - Active Once daily 90 mg hydrocortisone acetate and once daily placebo suppository administered with Sephure suppository applicator	Placebo Twice daily placebo suppository administered with Sephure suppository applicator
Overall Study STARTED	67	67	66
Overall Study COMPLETED	57	56	58
Overall Study NOT COMPLETED	10	11	8

Reasons for withdrawal

Reasons for withdrawal
Measure	Twice Daily - Active Twice daily 90 mg hydrocortisone acetate suppository administered with Sephure suppository applicator	Once Daily - Active Once daily 90 mg hydrocortisone acetate and once daily placebo suppository administered with Sephure suppository applicator	Placebo Twice daily placebo suppository administered with Sephure suppository applicator
Overall Study Physician Decision	1	3	2
Overall Study Withdrawal by Subject	1	1	2
Overall Study Adverse Event	4	2	3
Overall Study Randomization problem	0	1	0
Overall Study Pregnancy	0	0	1
Overall Study Geopolitical tension	1	0	0
Overall Study Lost to Follow-up	1	4	0
Overall Study Protocol Violation	2	0	0

Baseline Characteristics

Age was summarized using the Full Analysis Set (FAS) by randomized treatment assignment.

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: 29 days

Population: The reduction from 67 participants to 66 participants in the Once Daily Active arm was due to a randomization error.

Outcome measures

Outcome measures
Measure	Twice Daily - Active n=67 Participants Twice daily 90 mg hydrocortisone acetate suppository administered with Sephure suppository applicator	Once Daily - Active n=66 Participants Once daily 90 mg hydrocortisone acetate and once daily placebo suppository administered with Sephure suppository applicator	Placebo n=66 Participants Twice daily placebo suppository administered with Sephure suppository applicator
Clinical Remission	11 Participants Interval 1.3126 to 60.7941	14 Participants Interval 1.5305 to 69.1744	1 Participants

SECONDARY outcome

Timeframe: 29 days

Population: The reduction in participants of the Once Daily arm is due to a randomization error.

Reduction of stool frequency measured using Mayo Scoring sub score of stool frequency to assess the change in stool frequency from Baseline (Day 1) to End of Treatment (Day 29) and from Baseline (Day 1) to Follow-up (Day 15).

Outcome measures

Outcome measures
Measure	Twice Daily - Active n=67 Participants Twice daily 90 mg hydrocortisone acetate suppository administered with Sephure suppository applicator	Once Daily - Active n=66 Participants Once daily 90 mg hydrocortisone acetate and once daily placebo suppository administered with Sephure suppository applicator	Placebo n=66 Participants Twice daily placebo suppository administered with Sephure suppository applicator
Reduction of Stool Frequency Participants with Reduction in Stool Frequency at End of Treatment	34 participants	38 participants	26 participants
Reduction of Stool Frequency Participants with Reduction in Stool Frequency at Follow-up	27 participants	32 participants	21 participants

SECONDARY outcome

Timeframe: 29 days

Population: The reduction in QD Active participants is due to a randomization error.

Rectal Bleeding measured using Mayo Scoring sub-score of rectal bleeding equal to assess the change in rectal bleeding in active treatment groups vs. placebo group from Baseline (Day 1) to End of Treatment (Day 29) and from Baseline (Day 1) to Follow-up (Day 15).

Outcome measures

Outcome measures
Measure	Twice Daily - Active n=67 Participants Twice daily 90 mg hydrocortisone acetate suppository administered with Sephure suppository applicator	Once Daily - Active n=66 Participants Once daily 90 mg hydrocortisone acetate and once daily placebo suppository administered with Sephure suppository applicator	Placebo n=66 Participants Twice daily placebo suppository administered with Sephure suppository applicator
Rectal Bleeding Rectal Bleeding Score: 0, End of Treatment · Rectal Bleeding Score: 0, End of Treatment	34 Participants	31 Participants	10 Participants
Rectal Bleeding Rectal Bleeding Score: 0, Follow-up · Rectal Bleeding Score: 0, End of Treatment	21 Participants	26 Participants	11 Participants

Adverse Events

Twice Daily - Active

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Once Daily - Active

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Twice Daily - Active n=67 participants at risk Twice daily 90 mg hydrocortisone acetate suppository administered with Sephure suppository applicator	Once Daily - Active n=67 participants at risk Once daily 90 mg hydrocortisone acetate and once daily placebo suppository administered with Sephure suppository applicator	Placebo n=66 participants at risk Twice daily placebo suppository administered with Sephure suppository applicator
Gastrointestinal disorders Flatulence	3.0% 2/67 • Adverse events were reported from time of screening until end of trial (Safety and Symptom Follow-up Visit), 73 days.	4.5% 3/67 • Adverse events were reported from time of screening until end of trial (Safety and Symptom Follow-up Visit), 73 days.	0.00% 0/66 • Adverse events were reported from time of screening until end of trial (Safety and Symptom Follow-up Visit), 73 days.
Psychiatric disorders Insomnia	3.0% 2/67 • Adverse events were reported from time of screening until end of trial (Safety and Symptom Follow-up Visit), 73 days.	0.00% 0/67 • Adverse events were reported from time of screening until end of trial (Safety and Symptom Follow-up Visit), 73 days.	3.0% 2/66 • Adverse events were reported from time of screening until end of trial (Safety and Symptom Follow-up Visit), 73 days.
Gastrointestinal disorders Abdominal pain	3.0% 2/67 • Adverse events were reported from time of screening until end of trial (Safety and Symptom Follow-up Visit), 73 days.	3.0% 2/67 • Adverse events were reported from time of screening until end of trial (Safety and Symptom Follow-up Visit), 73 days.	3.0% 2/66 • Adverse events were reported from time of screening until end of trial (Safety and Symptom Follow-up Visit), 73 days.
Endocrine disorders Blood glucose increased	3.0% 2/67 • Adverse events were reported from time of screening until end of trial (Safety and Symptom Follow-up Visit), 73 days.	0.00% 0/67 • Adverse events were reported from time of screening until end of trial (Safety and Symptom Follow-up Visit), 73 days.	0.00% 0/66 • Adverse events were reported from time of screening until end of trial (Safety and Symptom Follow-up Visit), 73 days.
Nervous system disorders Headache	3.0% 2/67 • Adverse events were reported from time of screening until end of trial (Safety and Symptom Follow-up Visit), 73 days.	1.5% 1/67 • Adverse events were reported from time of screening until end of trial (Safety and Symptom Follow-up Visit), 73 days.	4.5% 3/66 • Adverse events were reported from time of screening until end of trial (Safety and Symptom Follow-up Visit), 73 days.
General disorders Pyrexia	3.0% 2/67 • Adverse events were reported from time of screening until end of trial (Safety and Symptom Follow-up Visit), 73 days.	0.00% 0/67 • Adverse events were reported from time of screening until end of trial (Safety and Symptom Follow-up Visit), 73 days.	3.0% 2/66 • Adverse events were reported from time of screening until end of trial (Safety and Symptom Follow-up Visit), 73 days.
Gastrointestinal disorders Abdominal distension	3.0% 2/67 • Adverse events were reported from time of screening until end of trial (Safety and Symptom Follow-up Visit), 73 days.	0.00% 0/67 • Adverse events were reported from time of screening until end of trial (Safety and Symptom Follow-up Visit), 73 days.	0.00% 0/66 • Adverse events were reported from time of screening until end of trial (Safety and Symptom Follow-up Visit), 73 days.
Renal and urinary disorders Leukocyturia	3.0% 2/67 • Adverse events were reported from time of screening until end of trial (Safety and Symptom Follow-up Visit), 73 days.	1.5% 1/67 • Adverse events were reported from time of screening until end of trial (Safety and Symptom Follow-up Visit), 73 days.	0.00% 0/66 • Adverse events were reported from time of screening until end of trial (Safety and Symptom Follow-up Visit), 73 days.
Infections and infestations COVID-19	1.5% 1/67 • Adverse events were reported from time of screening until end of trial (Safety and Symptom Follow-up Visit), 73 days.	3.0% 2/67 • Adverse events were reported from time of screening until end of trial (Safety and Symptom Follow-up Visit), 73 days.	0.00% 0/66 • Adverse events were reported from time of screening until end of trial (Safety and Symptom Follow-up Visit), 73 days.

Additional Information

Chief Scientific Officer

Cristcot

Phone: 978-212-6380

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee PIs are restricted from publication of data related to the study unless prior written authorization has been granted by the Sponsor.
Publication restrictions are in place

Restriction type: OTHER