A Study of SPH3127 in the Treatment of Mild to Moderate Ulcerative Colitis

• Sponsor: Shanghai Pharmaceuticals Holding Co., Ltd (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05770609
• Collaborator: (none)
• Enrollment: 108
• Locations: 2
• Arms: 3
• Anticipated Duration (Months): 23.1
• Patients Per Site: 54
• Patients Per Site Per Month: 2.3

Study Details

Study Description

Brief Summary

To preliminarily evaluate the clinical efficacy of the renin inhibitor SPH3127 Tablets in patients with mild to moderate ulcerative colitis with placebo as a control and determine the recommended dose.

Condition or Disease	Intervention/Treatment	Phase
Mild to Moderate Ulcerative Colitis	Drug: SPH3127 Tablets with Dose A; Drug: SPH3127 Tablets with Dose B; Drug: SPH3127 Tablets placebo	Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 108 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel, Dose-finding Phase II Clinical Study to Evaluate the Efficacy and Safety of SPH3127 Tablets in the Treatment of Mild to Moderate Ulcerative Colitis
• Anticipated Study Start Date: Mar 15, 2023
• Anticipated Primary Completion Date: Feb 15, 2025
• Anticipated Study Completion Date: Feb 15, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: SPH3127 Tablets with Dose A Oral daily dose of SPH3127 Tablets for up to 8 weeks	Drug: SPH3127 Tablets with Dose A; See Arm description
Experimental: SPH3127 Tablets with Dose B Oral daily dose of SPH3127 Tablets for up to 8 weeks	Drug: SPH3127 Tablets with Dose B; See Arm description
Placebo Comparator: SPH3127 Tablets placebo Oral daily dose of SPH3127 Tablets placebo for up to 8 weeks	Drug: SPH3127 Tablets placebo; See Arm description

Outcome Measures

Primary Outcome Measures

1. Symptom remission rate [Week8]

   Symptom remission rate

2. Endoscopic remission rate [Week8]

   Endoscopic remission rate

Secondary Outcome Measures

1. Clinical remission rate [Week8]

   Clinical remission rate

2. Symptom remission rate [Week2、Week4]

   Symptom remission rate

3. Safety and tolerability since the start of any study treatment. [Approximately 3 months]

   Incidence of adverse event and serious adverse event , correlation with study drug

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Aged 18 - 75 years, male or female;

2. Subjects who have been diagnosed with ulcerative colitis；

3. Subjects who agree to take effective contraceptive measures with their spouses throughout the study period and for up to 12 weeks after the last dose;

4. Subjects who thoroughly learn about the nature, significance, possible benefits, possible inconvenience and potential risks of the trial, understand the study procedures and voluntarily sign the informed consent form prior to their participation in the trial.

Exclusion Criteria:

1. Subjects who are diagnosed with Crohn's disease or indeterminate colitis;

2. Subjects with active infections at screening which may, as evaluated by the investigator, cause increased risks for subjects;

3. Subjects who had surgery that might impact the absorption of oral drugs, subjects who will undergo surgery during the study period, subjects who have undergone major surgery before screening, or subjects who have a plan of surgery during the study period;

4. Subjects and lactating women and those who will become pregnant within 6 months after the trial starts;

5. Subjects with a history of drug abuse with clinical significance within 1 year prior to screening;

6. Subjects with other diseases or conditions that the investigator considers unsuitable for this trial.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The First Affiliated Hospital，Sun Yat-sen University	Guangzhou	Guangdong	China	510080
2	Union Hospital Tongji Medical College Huazhong Universitu of Science and Technology	Wuhan	Hubei	China	430000

Sponsors and Collaborators

• Shanghai Pharmaceuticals Holding Co., Ltd

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Shanghai Pharmaceuticals Holding Co., Ltd
• ClinicalTrials.gov Identifier: NCT05770609
• Other Study ID Numbers: SPH3127-203
• First Posted: Mar 15, 2023
• Last Update Posted: Mar 20, 2023
• Last Verified: Mar 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Colitis; Colitis, Ulcerative; Ulcer

Study Results

No Results Posted as of Mar 20, 2023