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A Comparison of 122-0551 Foam Versus Vehicle Foam in Subjects With Plaque Psoriasis (Study 310)

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ClinicalTrials.gov Identifier: NCT02742441
Recruitment Status : Completed
First Posted : April 19, 2016
Results First Posted : November 14, 2018
Last Update Posted : November 14, 2018
Sponsor:
Information provided by (Responsible Party):
Therapeutics, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Plaque Psoriasis
Interventions Drug: 122-0551 Foam
Drug: Vehicle Foam
Enrollment 409
Recruitment Details

Recruitment period: June 2016 to February 2017

The location of clinical sites included dermatology clinics and clinical research centers.

Pre-assignment Details All subjects who met the entry criteria were randomized and enrolled into the study.
Arm/Group Title 122-0551 Foam Vehicle Foam
Hide Arm/Group Description

122-0511 Foam, topically applied twice daily

Intervention: Drug: 122-0551 Foam

122-0551 Foam: Topical Foam containing active drug

Vehicle Foam, topically applied twice daily

Intervention: Drug: Vehicle Foam

Vehicle Foam: Topical Foam containing no active drug

Period Title: Overall Study
Started 205 204
Completed 199 196
Not Completed 6 8
Reason Not Completed
Lost to Follow-up             4             4
Withdrawal by Subject             2             2
Adverse Event             0             2
Arm/Group Title 122-0551 Foam Vehicle Foam Total
Hide Arm/Group Description

122-0511 Foam, topically applied twice daily

Intervention: Drug: 122-0551 Foam

122-0551 Foam: Topical Foam containing active drug

Vehicle Foam, topically applied twice daily

Intervention: Drug: Vehicle Foam

Vehicle Foam: Topical Foam containing no active drug

Total of all reporting groups
Overall Number of Baseline Participants 205 204 409
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 205 participants 204 participants 409 participants
50.3  (13.9) 50.1  (14.0) 50.2  (13.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 205 participants 204 participants 409 participants
Female
92
  44.9%
86
  42.2%
178
  43.5%
Male
113
  55.1%
118
  57.8%
231
  56.5%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 205 participants 204 participants 409 participants
Hispanic or Latino
54
  26.3%
54
  26.5%
108
  26.4%
Not Hispanic or Latino
151
  73.7%
150
  73.5%
301
  73.6%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 205 participants 204 participants 409 participants
American Indian or Alaska Native
1
   0.5%
0
   0.0%
1
   0.2%
Asian
2
   1.0%
2
   1.0%
4
   1.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
1
   0.5%
1
   0.2%
Black or African American
11
   5.4%
15
   7.4%
26
   6.4%
White
190
  92.7%
185
  90.7%
375
  91.7%
More than one race
1
   0.5%
1
   0.5%
2
   0.5%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 205 participants 204 participants 409 participants
205 204 409
1.Primary Outcome
Title Percentage of Subjects Rated a "Treatment Success" Based on the Investigator's Global Assessment (IGA)
Hide Description The IGA score is a static evaluation of the overall or “average” degree of severity taking into account all of the subject’s psoriatic lesions in the Treatment Area by the investigator or designee. This evaluation takes into consideration the three individual characteristics of psoriasis (scaling, erythema and plaque elevation) with the IGA score at each visit representing the average of scaling, erythema or plaque elevation that is present amongst all of the lesions eligible for treatment. IGA will be assessed on a 5-point scale where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe.
Time Frame Day 15
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis shown is based on the intent-to-treat population, defined as all enrolled participants who were randomized and applied at least one dose of the test article.
Arm/Group Title 122-0551 Foam Vehicle Foam
Hide Arm/Group Description:

122-0511 Foam, topically applied twice daily

Intervention: Drug: 122-0551 Foam

122-0551 Foam: Topical Foam containing active drug

Vehicle Foam, topically applied twice daily

Intervention: Drug: Vehicle Foam

Vehicle Foam: Topical Foam containing no active drug

Overall Number of Participants Analyzed 205 204
Measure Type: Number
Unit of Measure: percentage of participants
30.7 7.4
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 122-0551 Foam, Vehicle Foam
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Treatment groups were compared with respect to the proportions of subjects with "treatment success" at Day 15 using the Cochran-Mantel-Haenszel (CMH) test stratified by analysis center.
Method Cochran-Mantel-Haenszel
Comments Missing data was imputed as treatment failure.
2.Secondary Outcome
Title Percentage of Subjects Rated a "Treatment Success" for Each of the Clinical Signs of Psoriasis (Scaling, Erythema and Plaque Elevation)
Hide Description Scaling, erythema and plaque elevation will each be scored on a 5-point scale where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe. These evaluations are an assessment of the overall or “average” degree of each of three key characteristics present within all of the subject’s psoriatic lesions in the Treatment Area by the investigator or designee.
Time Frame Day 15
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis shown is based on the Intent-to-Treat (ITT) population.
Arm/Group Title 122-0551 Foam Vehicle Foam
Hide Arm/Group Description:

122-0511 Foam, topically applied twice daily

Intervention: Drug: 122-0551 Foam

122-0551 Foam: Topical Foam containing active drug

Vehicle Foam, topically applied twice daily

Intervention: Drug: Vehicle Foam

Vehicle Foam: Topical Foam containing no active drug

Overall Number of Participants Analyzed 205 204
Measure Type: Number
Unit of Measure: percentage of participants
Plaque Elevation 35.0 9.9
Scaling 33.7 9.8
Erythema 28.8 8.3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 122-0551 Foam, Vehicle Foam
Comments Treatment groups were compared with respect to each of the clinical signs of psoriasis (plaque elevation, scaling, and erythema).
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Statistical significance was achieved for each of the clinical signs of psoriasis.
Method Cochran-Mantel-Haenszel
Comments Missing data was imputed as treatment failure.
3.Other Pre-specified Outcome
Title Percentage of Subjects Rated a "Treatment Success" Based on the Investigator's Global Assessment (IGA)
Hide Description [Not Specified]
Time Frame Day 8
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis shown is based on the ITT population. Only participants with observed values are reported.
Arm/Group Title 122-0551 Foam Vehicle Foam
Hide Arm/Group Description:

122-0511 Foam, topically applied twice daily

Intervention: Drug: 122-0551 Foam

122-0551 Foam: Topical Foam containing active drug

Vehicle Foam, topically applied twice daily

Intervention: Drug: Vehicle Foam

Vehicle Foam: Topical Foam containing no active drug

Overall Number of Participants Analyzed 199 196
Measure Type: Number
Unit of Measure: percentage of participants
9.5 3.6
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 122-0551 Foam, Vehicle Foam
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.012
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
4.Other Pre-specified Outcome
Title Percentage of Subjects Rated a "Treatment Success" for Each of the Clinical Signs of Psoriasis (Scaling, Erythema and Plaque Elevation)
Hide Description [Not Specified]
Time Frame Day 8
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis shown is based on the ITT population. Only participants with observed values are reported.
Arm/Group Title 122-0551 Foam Vehicle Foam
Hide Arm/Group Description:

122-0511 Foam, topically applied twice daily

Intervention: Drug: 122-0551 Foam

122-0551 Foam: Topical Foam containing active drug

Vehicle Foam, topically applied twice daily

Intervention: Drug: Vehicle Foam

Vehicle Foam: Topical Foam containing no active drug

Overall Number of Participants Analyzed 205 204
Measure Type: Number
Unit of Measure: percentage of participants
Plaque Elevation 13.2 3.6
Scaling 14.2 3.6
Erythema 8.0 3.1
5.Other Pre-specified Outcome
Title Change From Baseline in Pruritus Score
Hide Description At the Baseline Visit, prior to the first application of the test article, the subject’s overall experience of pruritus within the previous two (2) weeks will be assessed and scored (range 1-5) using a questionnaire that assesses the degree, duration, direction, disability, and distribution of the subject’s pruritus. Possible total scores range from 5 (no pruritus) to 25 (most severe pruritus). At Day 15, the overall experience of pruritus, in the previous two weeks, will be scored using the same questionnaire.
Time Frame Day 15
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis shown is based on the ITT population. Only participants with observed values are reported. Pruritus scores were based on the patient’s assessment of pruritus ranging from a score of 5 (no pruritus) to 25 (most severe pruritus).
Arm/Group Title 122-0551 Foam Vehicle Foam
Hide Arm/Group Description:

122-0511 Foam, topically applied twice daily

Intervention: Drug: 122-0551 Foam

122-0551 Foam: Topical Foam containing active drug

Vehicle Foam, topically applied twice daily

Intervention: Drug: Vehicle Foam

Vehicle Foam: Topical Foam containing no active drug

Overall Number of Participants Analyzed 205 204
Mean (Standard Deviation)
Unit of Measure: scores on a scale
-4.3  (3.8) -2.5  (3.3)
6.Other Pre-specified Outcome
Title Changes in Percent BSA With Active Psoriasis in the Treatment Area
Hide Description The percent (%) Body Surface Area (BSA) with active psoriasis in the Treatment Area will be determined at the Baseline Visit and Week 2 (Day 15) and documented. At Baseline, the percent BSA with active psoriasis in the Treatment Area must be 2% to 12%, inclusive.
Time Frame Day 15
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis shown is based on the ITT population. Only participants with observed values are reported. The mean percent BSA with active psoriasis at Baseline was 5.4% and 5.1% for the active and vehicle groups, respectively.
Arm/Group Title 122-0551 Foam Vehicle Foam
Hide Arm/Group Description:

122-0511 Foam, topically applied twice daily

Intervention: Drug: 122-0551 Foam

122-0551 Foam: Topical Foam containing active drug

Vehicle Foam, topically applied twice daily

Intervention: Drug: Vehicle Foam

Vehicle Foam: Topical Foam containing no active drug

Overall Number of Participants Analyzed 199 196
Mean (Standard Deviation)
Unit of Measure: Change in percent BSA
-1.5  (2.3) -0.2  (1.5)
Time Frame Adverse Events (AEs) were collected from Study Day 1 (enrollment/first dose) to study completion (Day 15) or participant termination. AEs that continued beyond completion/termination were followed until resolution or stabilization.
Adverse Event Reporting Description The safety population included all subjects enrolled in the study who were dispensed and applied the test article at least once; because the first dose of the test article was applied at the study site (Day 1), all enrolled subjects (N=409) were included in the safety population. Subjects reporting a particular AE more than once are counted only once for that AE.
 
Arm/Group Title 122-0551 Foam Vehicle Foam
Hide Arm/Group Description

122-0511 Foam, topically applied twice daily

Intervention: Drug: 122-0551 Foam

122-0551 Foam: Topical Foam containing active drug

Vehicle Foam, topically applied twice daily

Intervention: Drug: Vehicle Foam

Vehicle Foam: Topical Foam containing no active drug

All-Cause Mortality
122-0551 Foam Vehicle Foam
Affected / at Risk (%) Affected / at Risk (%)
Total   0/205 (0.00%)      0/204 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
122-0551 Foam Vehicle Foam
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/205 (0.00%)      1/204 (0.49%)    
Gastrointestinal disorders     
Gastric ulcer haemorrhage * 1 [1]  0/205 (0.00%)  0 1/204 (0.49%)  1
1
Term from vocabulary, MedDRA (19.0)
*
Indicates events were collected by non-systematic assessment
[1]
The SAE was deemed unrelated to test article.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
122-0551 Foam Vehicle Foam
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   12/205 (5.85%)      14/204 (6.86%)    
Eye disorders     
Blepharitis * 1  1/205 (0.49%)  1 1/204 (0.49%)  1
Gastrointestinal disorders     
Diarrhoea * 1  0/205 (0.00%)  0 1/204 (0.49%)  1
Gastric ulcer haemorrhage * 1  0/205 (0.00%)  0 1/204 (0.49%)  1
Gastritis haemorrhagic * 1  0/205 (0.00%)  0 1/204 (0.49%)  1
Gastrooesophageal reflux disease * 1  0/205 (0.00%)  0 1/204 (0.49%)  1
Nausea * 1  0/205 (0.00%)  0 1/204 (0.49%)  1
General disorders     
Application site pain  1  2/205 (0.98%)  2 1/204 (0.49%)  1
Application site pruritis * 1  0/205 (0.00%)  0 2/204 (0.98%)  2
Pyrexia * 1  0/205 (0.00%)  0 1/204 (0.49%)  1
Infections and infestations     
Sinusitis * 1  1/205 (0.49%)  1 0/204 (0.00%)  0
Skin infection * 1  1/205 (0.49%)  1 0/204 (0.00%)  0
Upper respiratory tract infection * 1  1/205 (0.49%)  1 1/204 (0.49%)  1
Urinary tract infection * 1  0/205 (0.00%)  0 1/204 (0.49%)  1
Injury, poisoning and procedural complications     
Hand fracture * 1  0/205 (0.00%)  0 1/204 (0.49%)  1
Radius fracture * 1  0/205 (0.00%)  0 1/204 (0.49%)  1
Musculoskeletal and connective tissue disorders     
Back pain * 1  1/205 (0.49%)  1 0/204 (0.00%)  0
Fracture pain * 1  0/205 (0.00%)  0 1/204 (0.49%)  1
Medial tibial stress syndrome * 1  0/205 (0.00%)  0 1/204 (0.49%)  1
Pain in extremity * 1  0/205 (0.00%)  0 1/204 (0.49%)  1
Nervous system disorders     
Migraine * 1  0/205 (0.00%)  0 1/204 (0.49%)  1
Headache * 1  3/205 (1.46%)  3 3/204 (1.47%)  3
Respiratory, thoracic and mediastinal disorders     
Nasal congestion * 1  1/205 (0.49%)  1 0/204 (0.00%)  0
Sinus congestion * 1  1/205 (0.49%)  1 0/204 (0.00%)  0
Vascular disorders     
Hypovolaemic shock * 1  0/205 (0.00%)  0 1/204 (0.49%)  1
1
Term from vocabulary, MedDRA (19.0)
*
Indicates events were collected by non-systematic assessment
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The Sponsor has first right to publish pooled study data. In the event that such manuscript has not been submitted for publication within 12 months from study completion/termination at all participating sites, the PI shall have the right to single center publications provided they submit any data for presentation, oral or written, to the Sponsor for review 30 days prior to public disclosure. The PI may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Clinical Research, Therapeutics, Inc.
Organization: Therapeutics, Inc.
Phone: 858-571-1800
EMail: clinicalresearch@therapeuticsinc.com
Layout table for additonal information
Responsible Party: Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT02742441     History of Changes
Other Study ID Numbers: 122-0551-310
First Submitted: April 14, 2016
First Posted: April 19, 2016
Results First Submitted: September 17, 2018
Results First Posted: November 14, 2018
Last Update Posted: November 14, 2018