CLINICAL TRIALS PROFILE FOR LENABASUM

Clinical Trials for Lenabasum

Trial ID	Title	Status	Sponsor	Phase	Summary
NCT02465450 ↗	Safety, Tolerability, Pharmacokinetics, and Efficacy of JBT-101 (Lenabasum) in Cystic Fibrosis	Completed	Corbus Pharmaceuticals Inc.	Phase 2	The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and efficacy of JBT-101 in adult subjects with cystic fibrosis (CF).
NCT02466243 ↗	Safety, Tolerability, and Efficacy of JBT-101 in Subjects With Dermatomyositis	Terminated	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)	Phase 2	The purpose of this study is to evaluate the safety, tolerability and efficacy of JBT-101 in adult subjects with skin-predominant, dermatomyositis (DM) that is refractory to at least 3 months treatment with hydroxychloroquine.
NCT02466243 ↗	Safety, Tolerability, and Efficacy of JBT-101 in Subjects With Dermatomyositis	Terminated	University of Pennsylvania	Phase 2	The purpose of this study is to evaluate the safety, tolerability and efficacy of JBT-101 in adult subjects with skin-predominant, dermatomyositis (DM) that is refractory to at least 3 months treatment with hydroxychloroquine.
NCT02466243 ↗	Safety, Tolerability, and Efficacy of JBT-101 in Subjects With Dermatomyositis	Terminated	Corbus Pharmaceuticals Inc.	Phase 2	The purpose of this study is to evaluate the safety, tolerability and efficacy of JBT-101 in adult subjects with skin-predominant, dermatomyositis (DM) that is refractory to at least 3 months treatment with hydroxychloroquine.
NCT03093402 ↗	JBT-101 in Systemic Lupus Erythematosus (SLE)	Completed	Autoimmunity Centers of Excellence	Phase 2	The objective of this study is to evaluate the efficacy, safety, and tolerability of JBT-101 (also known as lenabasum) in systemic lupus erythematosus (SLE). - One hundred adults with active joint disease and at least moderate pain will be enrolled in this study to evaluate treatment of their systemic lupus erythematosus (SLE) with JBT-101. JBT-101 is a synthetic endocannabinoid receptor type 2 (CB2) agonist and an activator of the body's normal processes, to resolve innate immune responses without immunosuppression. - Participants will receive 2 doses of JBT-101 by mouth (three groups of varying doses) or, placebo, for 84 days and will continue to be followed for an additional 28 days. Participant visits to assess endpoints occur on Day 1, then every 2 weeks twice, then every 4 weeks three times, for a total of six visits. - The change in maximum daily pain Numerical Rating Scale (NRS) score from Baseline (Visit 1) will be assessed at every visit.
NCT03093402 ↗	JBT-101 in Systemic Lupus Erythematosus (SLE)	Completed	Corbus Pharmaceuticals Inc.	Phase 2	The objective of this study is to evaluate the efficacy, safety, and tolerability of JBT-101 (also known as lenabasum) in systemic lupus erythematosus (SLE). - One hundred adults with active joint disease and at least moderate pain will be enrolled in this study to evaluate treatment of their systemic lupus erythematosus (SLE) with JBT-101. JBT-101 is a synthetic endocannabinoid receptor type 2 (CB2) agonist and an activator of the body's normal processes, to resolve innate immune responses without immunosuppression. - Participants will receive 2 doses of JBT-101 by mouth (three groups of varying doses) or, placebo, for 84 days and will continue to be followed for an additional 28 days. Participant visits to assess endpoints occur on Day 1, then every 2 weeks twice, then every 4 weeks three times, for a total of six visits. - The change in maximum daily pain Numerical Rating Scale (NRS) score from Baseline (Visit 1) will be assessed at every visit.
NCT03093402 ↗	JBT-101 in Systemic Lupus Erythematosus (SLE)	Completed	Rho Federal Systems Division, Inc.	Phase 2	The objective of this study is to evaluate the efficacy, safety, and tolerability of JBT-101 (also known as lenabasum) in systemic lupus erythematosus (SLE). - One hundred adults with active joint disease and at least moderate pain will be enrolled in this study to evaluate treatment of their systemic lupus erythematosus (SLE) with JBT-101. JBT-101 is a synthetic endocannabinoid receptor type 2 (CB2) agonist and an activator of the body's normal processes, to resolve innate immune responses without immunosuppression. - Participants will receive 2 doses of JBT-101 by mouth (three groups of varying doses) or, placebo, for 84 days and will continue to be followed for an additional 28 days. Participant visits to assess endpoints occur on Day 1, then every 2 weeks twice, then every 4 weeks three times, for a total of six visits. - The change in maximum daily pain Numerical Rating Scale (NRS) score from Baseline (Visit 1) will be assessed at every visit.

Clinical Trial Conditions for Lenabasum

Condition Name

Condition Name
Intervention	Trials
Cystic Fibrosis	2
Dermatomyositis	2
Diffuse Cutaneous Systemic Sclerosis	1
Lupus	1

Condition MeSH

Condition MeSH
Intervention	Trials
Dermatomyositis	2
Fibrosis	2
Cystic Fibrosis	2
Scleroderma, Systemic	1

Clinical Trial Locations for Lenabasum

Trials by Country

+

−

Trials by Country
Location	Trials
United States	74
United Kingdom	9
Germany	6
Poland	4
Netherlands	3

Trials by US State

+

−

Trials by US State
Location	Trials
Pennsylvania	5
South Carolina	5
Ohio	5
New York	5
California	5

Clinical Trial Progress for Lenabasum

Clinical Trial Phase

Clinical Trial Phase
Clinical Trial Phase	Trials
Phase 3	2
Phase 2	4

Clinical Trial Status

Clinical Trial Status
Clinical Trial Phase	Trials
Completed	3
Terminated	2
Active, not recruiting	1

Clinical Trial Sponsors for Lenabasum

Sponsor Name

Sponsor Name
Sponsor	Trials
Corbus Pharmaceuticals Inc.	6
Autoimmunity Centers of Excellence	1
Rho Federal Systems Division, Inc.	1

Sponsor Type

Sponsor Type
Sponsor	Trials
Industry	7
Other	4
NIH	2