Trial Outcomes & Findings for A Comparison of DFD01 Spray Versus Vehicle Spray in Subjects With Moderate Psoriasis (NCT NCT01967069)

Results Overview

IGA of clear or almost clear

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

277 participants

Primary outcome timeframe

Day 15

Results posted on

2024-03-07

Participant milestones
Measure	DFD01 Spray DFD01 Spray twice daily DFD01 Spray	Vehicle Spray Vehicle Spray twice daily Vehicle Spray
Overall Study STARTED	182	95
Overall Study COMPLETED	174	87
Overall Study NOT COMPLETED	8	8

Reasons for withdrawal
Measure	DFD01 Spray DFD01 Spray twice daily DFD01 Spray	Vehicle Spray Vehicle Spray twice daily Vehicle Spray
Overall Study Adverse Event	2	2
Overall Study Lost to Follow-up	5	2
Overall Study Withdrawal by Subject	1	3
Overall Study Lack of Efficacy	0	1

A Comparison of DFD01 Spray Versus Vehicle Spray in Subjects With Moderate Psoriasis

Baseline characteristics by cohort
Measure	DFD01 Spray n=182 Participants DFD01 Spray twice daily DFD01 Spray	Vehicle Spray n=95 Participants Vehicle Spray twice daily Vehicle Spray	Total n=277 Participants Total of all reporting groups
Age, Continuous	50.3 years STANDARD_DEVIATION 14.72 • n=5 Participants	49.9 years STANDARD_DEVIATION 12.90 • n=7 Participants	50.2 years STANDARD_DEVIATION 14.10 • n=5 Participants
Sex: Female, Male Female	68 Participants n=5 Participants	37 Participants n=7 Participants	105 Participants n=5 Participants
Sex: Female, Male Male	114 Participants n=5 Participants	58 Participants n=7 Participants	172 Participants n=5 Participants
Region of Enrollment United States	182 participants n=5 Participants	95 participants n=7 Participants	277 participants n=5 Participants
% Body Surface Area	13.7 Percent STANDARD_DEVIATION 3.72 • n=5 Participants	13.4 Percent STANDARD_DEVIATION 3.49 • n=7 Participants	13.6 Percent STANDARD_DEVIATION 3.64 • n=5 Participants
Participants with Moderate Psoriasis According to the Investigator's Global Assessment (IGA)	182 Participants n=5 Participants	95 Participants n=7 Participants	277 Participants n=5 Participants

Timeframe: Day 15

Population: Intent to Treat

IGA of clear or almost clear

Outcome measures
Measure	DFD01 Spray n=182 Participants DFD01 Spray twice daily DFD01 Spray	Vehicle Spray n=95 Participants Vehicle Spray twice daily Vehicle Spray
Percentage of Participants With Treatment Success According to the Investigator's Global Assessment (IGA)	21.50 percentage of subjects Interval 15.5 to 27.5	7.4 percentage of subjects Interval 2.1 to 12.7

Serious events: 1 serious events

Other events: 17 other events

Deaths: 0 deaths

Serious events: 2 serious events

Other events: 24 other events

Deaths: 0 deaths

Serious adverse events
Measure	DFD01 Spray n=179 participants at risk DFD01 Spray twice daily DFD01 Spray	Vehicle Spray n=93 participants at risk Vehicle Spray twice daily Vehicle Spray
Gastrointestinal disorders Upper Gastrointestinal Bleed	0.56% 1/179 • Number of events 1 Three subjects in the betamethasone dipropionate spray 0.05% group and two subjects in the vehicle spray group had no post-baseline safety evaluations.	0.00% 0/93 Three subjects in the betamethasone dipropionate spray 0.05% group and two subjects in the vehicle spray group had no post-baseline safety evaluations.
Infections and infestations Infection Right Foot	0.00% 0/179 Three subjects in the betamethasone dipropionate spray 0.05% group and two subjects in the vehicle spray group had no post-baseline safety evaluations.	1.1% 1/93 • Number of events 1 Three subjects in the betamethasone dipropionate spray 0.05% group and two subjects in the vehicle spray group had no post-baseline safety evaluations.
Psychiatric disorders Exacerbation of Schizophrenia	0.00% 0/179 Three subjects in the betamethasone dipropionate spray 0.05% group and two subjects in the vehicle spray group had no post-baseline safety evaluations.	1.1% 1/93 • Number of events 1 Three subjects in the betamethasone dipropionate spray 0.05% group and two subjects in the vehicle spray group had no post-baseline safety evaluations.

Other adverse events
Measure	DFD01 Spray n=179 participants at risk DFD01 Spray twice daily DFD01 Spray	Vehicle Spray n=93 participants at risk Vehicle Spray twice daily Vehicle Spray
General disorders Application Site Pain	2.8% 5/179 • Number of events 5 Three subjects in the betamethasone dipropionate spray 0.05% group and two subjects in the vehicle spray group had no post-baseline safety evaluations.	10.8% 10/93 • Number of events 10 Three subjects in the betamethasone dipropionate spray 0.05% group and two subjects in the vehicle spray group had no post-baseline safety evaluations.
General disorders Application Site Pruritus	6.7% 12/179 • Number of events 12 Three subjects in the betamethasone dipropionate spray 0.05% group and two subjects in the vehicle spray group had no post-baseline safety evaluations.	15.1% 14/93 • Number of events 14 Three subjects in the betamethasone dipropionate spray 0.05% group and two subjects in the vehicle spray group had no post-baseline safety evaluations.

Promius Pharma

Phone: 609-282-1476

Restriction type: GT60