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

Sponsor ID
20210147
Clinicaltrials.gov ID
NCT05891119
EUCTIS ID
N/A
EudraCT ID
N/A

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).

Additional Study Details

Phase
Early Phase 1
Product
Rocatinlimab
Type
Interventional
Masking
None (Open Label)
Enrollment
21
Additional Study Details

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
Status
Contact Us
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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