Study Complete
Sponsor ID
20200195

Phase 3, Randomized Study of Apremilast in Japanese Participants with Palmoplantar Pustulosis (PPP)

Sponsor ID
20200195
Clinicaltrials.gov ID
NCT05174065
EUCTIS ID
N/A
EudraCT ID
N/A

Study Details

The primary objective of the study is to evaluate the efficacy of apremilast (AMG 407) twice daily (BID) compared with placebo in participants with Palmoplantar Pustulosis (PPP).

Additional Study Details

Phase
Phase 3
Product
Otezla
Type
Interventional
Masking
Double (Participant, Investigator)
Enrollment
176
Additional Study Details

Protocol Summary

Primary Outcome Measures

Number of participants achieving at least 50% reduction from baseline in Palmoplantar Pustulosis Area and Severity Index (PPPASI) total score (PPPASI-50) at week 16

Timeframe: 16 weeks

Secondary Outcome Measures

Change from baseline in PPPASI total score at week 16

Timeframe: 16 weeks

Change from baseline in Palmoplantar Pustulosis Severity Index (PPSI) total score at week 16

Timeframe: 16 weeks

Change from baseline in Visual Analogue Scale (VAS) assessment for Palmoplantar Pustulosis (PPP) symptoms (pruritis and pain/discomfort) at week 16

Timeframe: 16 weeks

Change from Baseline in Dermatology Life Quality Index (DLQI) total score at week 16

Timeframe: 16 weeks

Number of participants with treatment-emergent adverse events

Timeframe: 56 weeks

Locations

Location
Status
Contact Us
Location
Nagaoka Red Cross Hospital
Nagaoka-shi, Niigata, Japan, 940-2085
Status
Recruiting
Location
Higuchi Dermatology Urology Clinic
Kasuga-shi, Fukuoka, Japan, 816-0802
Status
Recruiting
Location
Kobe University Hospital
Kobe-shi, Hyogo, Japan, 650-0017
Status
Recruiting
Location
Nagata Dermatology Clinic
Ogori-shi, Fukuoka, Japan, 838-0144
Status
Recruiting
Location
Medical Corporation Goto Dermatology Clinic
Osaka-shi, Osaka, Japan, 554-0021
Status
Recruiting
Location
Pansy Skin Clinic
Saitama-shi, Saitama, Japan, 330-0064
Status
Recruiting
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