CLINICAL TRIALS PROFILE FOR RIDINILAZOLE

Clinical Trials for ridinilazole

Trial ID	Title	Status	Sponsor	Phase	Summary
NCT02784002 ↗	A Study of Ridinilazole (SMT19969) Compared With Fidaxomicin for the Treatment of Clostridium Difficile Infection (CDI)	Completed	Summit Therapeutics	Phase 2	The purpose of this research study is to evaluate the safety and effectiveness of Ridinilazole (SMT19969) in treating C. difficile Infection (CDI).
NCT03595553 ↗	Comparison of Ridinilazole Versus Vancomycin Treatment for Clostridium Difficile Infection	Active, not recruiting	Summit Therapeutics	Phase 3	Summit is developing ridinilazole as a novel antimicrobial for Clostridioides difficile Infection (CDI), formerly known as Clostridium difficile Infection, with the goal of demonstrating an improved Sustained Clinical Response rate in subjects treated with ridinilazole as compared to subjects treated with vancomycin. A phase 2 proof of concept study, with vancomycin as comparator, demonstrated these attributes with a comparable safety profile. A high fecal concentration of ridinilazole and little systemic exposure were noted. The rationale for this phase 3 study is to confirm the improvement in sustained clinical response of CDI over vancomycin and to compare the safety and tolerability of ridinilazole to that of vancomycin. Ridinilazole plasma concentration will be assessed in a subset of patients.
NCT03595566 ↗	To Compare Ridinilazole Versus Vancomycin Treatment for Clostridium Difficile Infection	Active, not recruiting	Summit Therapeutics	Phase 3	Summit is developing ridinilazole as a novel antimicrobial for Clostridioides difficile Infection (CDI), formerly known as Clostridium difficile Infection, with the goal of demonstrating an improved Sustained Clinical Response rate in subjects treated with ridinilazole as compared to subjects with vancomycin. A phase 2 proof of concept study, with vancomycin as comparator, demonstrated these attributes with a comparable safety profile. A high fecal concentration of ridinilazole and little systemic exposure were noted. The rationale for this phase 3 study is to confirm the improvement in sustained clinical response of CDI over vancomycin and to compare the safety and tolerability of ridinilazole to that of vancomycin.

Clinical Trial Conditions for ridinilazole

Condition Name

Condition Name
Intervention	Trials
Clostridioides Difficile Infection	3
Clostridium Difficile Infection	3

Condition MeSH

Condition MeSH
Intervention	Trials
Infections	4
Infection	4
Communicable Diseases	4

Clinical Trial Locations for ridinilazole

Trials by Country

Trials by Country
Location	Trials
United States	58
Canada	9
Korea, Republic of	6
Brazil	4
Australia	4

Trials by US State

Trials by US State
Location	Trials
Idaho	4
California	4
Ohio	3
New York	3
Michigan	3

Clinical Trial Progress for ridinilazole

Clinical Trial Phase

Clinical Trial Phase
Clinical Trial Phase	Trials
Phase 3	3
Phase 2	1

Clinical Trial Status

Clinical Trial Status
Clinical Trial Phase	Trials
Active, not recruiting	2
Completed	1
Recruiting	1

Clinical Trial Sponsors for ridinilazole

Sponsor Name

Sponsor Name
Sponsor	Trials
Summit Therapeutics	4
Department of Health and Human Services	1

Sponsor Type

Sponsor Type
Sponsor	Trials
Industry	4
U.S. Fed	1