CLINICAL TRIALS PROFILE FOR BIIB104

Clinical Trials for BIIB104

Trial ID	Title	Status	Sponsor	Phase	Summary
NCT03745820 ↗	A Study to Evaluate the Safety and Efficacy of BIIB104 in Participants With Cognitive Impairment Associated With Schizophrenia (CIAS)	Recruiting	Biogen	Phase 2	The primary objective of the study is to evaluate the efficacy of BIIB104 in participants with CIAS, using the Working Memory Domain of the MATRICS Consensus Cognitive Battery (MCCB). The secondary objectives of this study are to evaluate the safety and tolerability of BIIB104 in participants with CIAS, and to evaluate the efficacy of BIIB104 in participants with CIAS on measures of cognition, functioning, and psychiatric symptomology.
NCT04068532 ↗	A Study to Explore Pharmacodynamic Effects of BIIB104 on Brain Circuitry in Healthy Participants	Completed	Biogen	Phase 1	The primary objective of the study is to explore the pharmacodynamic (PD) effects of BIIB104 on brain circuitry associated with emotional processing in healthy participants. The secondary objectives of the study are to evaluate the safety and tolerability of BIIB104 in healthy participants; To further explore the PD effects of BIIB104 on brain circuitry associated with emotional processing in healthy participants; To explore the PD effects of BIIB104 on brain circuitry associated with working memory in healthy participants using the N-Back; To explore the PD effects of BIIB104 on regional cerebral blood flow (CBF) in healthy participants; To explore the PD effects of BIIB104 on brain circuitry during resting state in healthy participants.
NCT04079101 ↗	Study to Assess the Safety, Tolerability, and Pharmacokinetics of BIIB104 in Healthy Japanese and Non-Japanese Participants	Completed	Biogen	Phase 1	The primary objective is to evaluate the pharmacokinetics (PK) of BIIB104 in healthy Japanese and non-Japanese participants. The secondary objective is to evaluate the safety and tolerability of multiple, oral doses of BIIB104 administered BID for 9 days, with an additional dose occurring in the morning on Day 10 in healthy Japanese and non-Japanese participants.
NCT05148481 ↗	A Study to Evaluate Safety and Pharmacokinetics of BIIB104 in Healthy Japanese and Non-Japanese Participants	Recruiting	Biogen	Phase 1	The primary objective of the study is to evaluate the pharmacokinetics (PK) of BIIB104 in healthy Japanese and non-Japanese participants. The secondary objective of the study is to evaluate the safety and tolerability of multiple, oral doses of BIIB104 administered twice daily (BID) for 9 days, with an additional dose occurring in the morning on Day 10 in healthy Japanese and non-Japanese participants.

Clinical Trial Conditions for BIIB104

Condition Name

Condition Name
Intervention	Trials
Healthy Volunteers	3
Cognitive Impairment Associated With Schizophrenia	1
Healthy Volunteer	1
Schizophrenia	1

Condition MeSH

Condition MeSH
Intervention	Trials
Schizophrenia	1
Cognitive Dysfunction	1

Clinical Trial Locations for BIIB104

Trials by Country

Trials by Country
Location	Trials
United States	17
United Kingdom	5
Spain	4
Germany	3
Japan	1

Trials by US State

Trials by US State
Location	Trials
California	3
Michigan	1
Maryland	1
Illinois	1
Georgia	1

Clinical Trial Progress for BIIB104

Clinical Trial Phase

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

Clinical Trial Status

Clinical Trial Status
Clinical Trial Phase	Trials
Completed	2
Recruiting	2
Not yet recruiting	1

Clinical Trial Sponsors for BIIB104

Sponsor Name

Sponsor Name
Sponsor	Trials
Biogen	5

Sponsor Type

Sponsor Type
Sponsor	Trials
Industry	5