Trial Outcomes & Findings for Evaluation of Add on Enstilar in Patients Using Otezla for Psoriasis (NCT NCT03587194)

Last Updated: 2024-04-16

Results Overview

Patients who achieve Psoriasis Area Severity Index 75 at week 12. PASI scores range 0-72 (maximal disease)

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

50 participants

Primary outcome timeframe

12 weeks

Results posted on

2024-04-16

Participant milestones
Measure	Otezla Enstilar Otezla: Otezla 30mg BID Enstilar QD
Overall Study STARTED	50
Overall Study COMPLETED	23
Overall Study NOT COMPLETED	27

Withdrawal data not reported

Evaluation of Add on Enstilar in Patients Using Otezla for Psoriasis

Baseline characteristics by cohort
Measure	Otezla Enstilar n=50 Participants Otezla 30mg BID Enstilar QD
Age, Continuous	48 years n=5 Participants
Sex: Female, Male Female	33 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	10 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants
Race (NIH/OMB) White	36 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	50 participants n=5 Participants

Timeframe: 12 weeks

Patients who achieve Psoriasis Area Severity Index 75 at week 12. PASI scores range 0-72 (maximal disease)

Outcome measures
Measure	Otezla Enstilar n=31 Participants Otezla: Otezla 30mg BID Enstilar QD
Psoriasis Area Severity Index 75 at Week 12	29 Participants

Serious events: 1 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events
Measure	Otezla Enstilar n=31 participants at risk Otezla: Otezla 30mg BID Enstilar QD
Ear and labyrinth disorders mastoiditis	3.2% 1/31 • Number of events 1 • 16 weeks

Other adverse events
Measure	Otezla Enstilar n=31 participants at risk Otezla: Otezla 30mg BID Enstilar QD
Gastrointestinal disorders diarrhea	16.1% 5/31 • Number of events 5 • 16 weeks
Gastrointestinal disorders nausea	12.9% 4/31 • Number of events 4 • 16 weeks
Skin and subcutaneous tissue disorders folliculitis	6.5% 2/31 • Number of events 2 • 16 weeks
Musculoskeletal and connective tissue disorders leg pain	6.5% 2/31 • Number of events 2 • 16 weeks
Skin and subcutaneous tissue disorders Verrucous acanthoma	3.2% 1/31 • Number of events 2 • 16 weeks
Gastrointestinal disorders vomiting	6.5% 2/31 • Number of events 2 • 16 weeks

Psoriasis Treatment Center of Central New Jersey

Phone: 6094434500