Study Complete
Sponsor ID
20210147
Study to Investigate the Effect of Rocatinlimab (AMG 451) on the Pharmacokinetics of Multiple Cytochrome P450 (CYP450) Substrates in Participants with Moderate to Severe Atopic Dermatitis
Study Details
The primary objective of the study is to evaluate the pharmacokinetics (PK) of multiple cytochrome P450 (CYP450) substrates alone and in combination with rocatinlimab in participants with moderate to severe atopic dermatitis (AD).
Protocol Summary
Primary Outcome Measures
Maximum Observed Serum Concentration (Cmax) of CYP450 Substrate
Timeframe: Day 1
Cmax of CYP450 Substrate
Timeframe: Day 120
Area Under the Serum Concentration-Time Curve from Time Zero to Time of Last Quantifiable Concentration (AUClast) of CYP450 Substrate
Timeframe: Day 1
AUClast of CYP450 Substrate
Timeframe: Day 120
Area Under the Serum Concentration-Time Curve from Time Zero to Infinity (AUCinf) of CYP450 Substrate
Timeframe: Day 1
AUCinf of CYP450 Substrate
Timeframe: Day 120
Secondary Outcome Measures
Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Timeframe: Up to Day 238
Number of Participants with Serious Adverse Events (SAEs)
Timeframe: Up to Day 238
Number of Participants with Anti-rocatinlimab Antibody Formation
Timeframe: Up to Day 238
Locations
Location
DermDox Dermatology Centers, PC - Camp Hill
Camp Hill, PA, United States, 17011
Status
Terminated
Location
Axis Clinicals, LCC
Dilworth, MN, United States, 56529
Status
Recruiting
Location
Velocity Clinical Research, North Hollywood
North Hollywood, CA, United States, 91606-1570
Status
Terminated
Location
Accel Research Sites (ACR)
Deland, FL, United States, 32720-3134
Status
Terminated
Location
Velocity Clinical Research -Spartanburg
Spartanburg, South Carolina, United States, 29303-4225
Status
Terminated
Location
Direct Helpers Research Center (DHRC)
Hialeah, FL, United States, 33012-3618
Status
Recruiting
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