CLINICAL TRIALS PROFILE FOR SEMAPIMOD

Clinical Trials for Semapimod

Trial ID	Title	Status	Sponsor	Phase	Summary
NCT00038766 ↗	CNI-1493 for Treatment of Moderate to Severe Crohn's Disease	Terminated	Ferring Pharmaceuticals	Phase 2	The purpose of this study is to determine whether CNI-1493 is safe and effective in the treatment of moderate to severe Crohn's Disease.
NCT00739986 ↗	Semapimod for Treatment of Moderate to Severe Crohn's Disease 1 or 3 Days' Treatment Versus Placebo	Completed	Ferring Pharmaceuticals	Phase 2	Assessment of the number of days' treatment with semapimod necessary for efficacy, as measured by response rate to CNI-1493 as compared to placebo, in patients with moderate to severe Crohn's disease (CD).
NCT00740103 ↗	Long-term Study of Semapimod (CNI-1493) for Treatment of Crohn's Disease	Completed	Ferring Pharmaceuticals	Phase 2	CNI-1493-CD05 is an open-label extension study of CNI-1493-CD04. In the CD05 study, patients are eligible for up to 5 courses of semapimod 60 mg IV x 3 days every 6 - 8 weeks. Primary objective is assessment of the efficacy of cumulative doses of semapimod measured by decrease in Crohn's Disease Activity Index (CDAI).
NCT00741910 ↗	Extension Study of Semapimod 60 mg IV x 3 Days	Completed	Ferring Pharmaceuticals	Phase 2	Study CNI-1493-CD06 is an open, single-arm extension studies to CD03 and CD05. CDAI is the only efficacy measure assessed in this study. The safety of multiple courses of semapimod is to be determined by the incidence of clinical and laboratory adverse events.
NCT00950105 ↗	Single Ascending Dose Study of Oral CPSI-2364 (Semapimod)	Completed	Ferring Pharmaceuticals	Phase 1	This study will be conducted in healthy male or female subjects using a double-blind, randomized, placebo-controlled, single-dose design. Up to 30 subjects will be enrolled; 3 healthy subjects in Cohorts 1 and 2 (2 active, 1 placebo) and 8 healthy subjects in Cohorts 3 to 5 (6 active, 2 placebo). The following CPSI-2364 doses are proposed: 1 mg, 10 mg, 30 mg, 90 mg, and 270 mg.Safety will be evaluated throughout the study and include physical examinations, vital signs assessments, 12-lead electrocardiograms (ECGs), routine clinical laboratory tests (including blood chemistry, hematology, coagulation, and urinalysis), and adverse event (AE) assessments. Vital sign assessments and 12-lead ECGs will be performed repeatedly over the 24-hour observation period. Venous blood samples will be taken at specified intervals and tested for the presence of CPSI-2364.

Clinical Trial Conditions for Semapimod

Condition Name

Condition Name
Intervention	Trials
Crohn's Disease	4
Crohn Disease	1

Condition MeSH

Condition MeSH
Intervention	Trials
Crohn Disease	5

Clinical Trial Locations for Semapimod

Trials by Country

Trials by Country
Location	Trials
United States	23
Netherlands	3
Israel	3
Germany	3
Belgium	2

Trials by US State

Trials by US State
Location	Trials
New York	4
Illinois	4
Georgia	3
California	3
Tennessee	2

Clinical Trial Progress for Semapimod

Clinical Trial Phase

Clinical Trial Phase
Clinical Trial Phase	Trials
Phase 2	4
Phase 1	1

Clinical Trial Status

Clinical Trial Status
Clinical Trial Phase	Trials
Completed	4
Terminated	1

Clinical Trial Sponsors for Semapimod

Sponsor Name

Sponsor Name
Sponsor	Trials
Ferring Pharmaceuticals	5

Sponsor Type

Sponsor Type
Sponsor	Trials
Industry	5