Trial Outcomes & Findings for Brodalumab in Subjects With Moderate to Severe Plaque Psoriasis Who Have Failed IL-17A Therapies (NCT NCT03403036)

Results Overview

Number of patients achieving a score of "0-clear" or "1-almost clear" in the sPGA score after 16 weeks of treatment to measure efficacy. Static Physician Global Assessment (sPGA) - 3 categories induration, erythema, and scaling, scored 0-4, these 3 categories averaged giving total score from 0-4, with higher score indicating more symptoms.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

39 participants

Primary outcome timeframe

16 weeks

Results posted on

2021-03-10

Participant Flow

41 patients screened with 39 meeting all eligibility requirements. Patients with moderate-to-severe psoriasis were recruited from 3 sites.

Participant milestones

Participant milestones
Measure	Brodalumab Brodalumab (210 mg) via subcutaneous injection using prefilled syringes given at Weeks 0, 1, 2, and every 2 weeks thereafter through and including Week 16.
Overall Study STARTED	39
Overall Study COMPLETED	34
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Brodalumab Brodalumab (210 mg) via subcutaneous injection using prefilled syringes given at Weeks 0, 1, 2, and every 2 weeks thereafter through and including Week 16.
Overall Study Lack of Efficacy	5

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Brodalumab n=39 Participants Brodalumab (210 mg) via subcutaneous injection using prefilled syringes given at Weeks 0, 1, 2, and every 2 weeks thereafter through and including Week 16.
Age, Continuous	50.74 years STANDARD_DEVIATION 2.64 • n=39 Participants
Sex: Female, Male Female	14 Participants n=39 Participants
Sex: Female, Male Male	25 Participants n=39 Participants
Baseline PASI	20.36 units on a scale STANDARD_DEVIATION 2.24 • n=39 Participants
Baseline sPGA	3.41 units on a scale STANDARD_DEVIATION 0.08 • n=39 Participants
Number of participants who failed Secukinumab	16 Participants n=39 Participants
Number of participants who failed Ixekizumab	19 Participants n=39 Participants
Number of participants who failed both Secukinumab and Ixekizumab	4 Participants n=39 Participants
Number of previously failed biologics	2.23 biologic medications STANDARD_DEVIATION 0.29 • n=39 Participants

PRIMARY outcome

Timeframe: 16 weeks

Number of patients achieving a score of "0-clear" or "1-almost clear" in the sPGA score after 16 weeks of treatment to measure efficacy. Static Physician Global Assessment (sPGA) - 3 categories induration, erythema, and scaling, scored 0-4, these 3 categories averaged giving total score from 0-4, with higher score indicating more symptoms.

Outcome measures

Outcome measures
Measure	Brodalumab n=34 Participants Brodalumab (210 mg) via subcutaneous injection using prefilled syringes given at Weeks 0, 1, 2, and every 2 weeks thereafter through and including Week 16.
Number of Patients With Physician's Global Assessment (sPGA) Score 0 or 1	24 Participants

SECONDARY outcome

Timeframe: 16 weeks

PASI combines the assessment of the severity of lesions and the area affected into a single score in the range 0 (no disease) to 72 (maximal disease). Number of participants with 75%, 90%, and 100% reduction in the PASI score, respectively, PASI-75, PASI-90, and PASI-100 who completed the trial at week 16.

Outcome measures

Outcome measures
Measure	Brodalumab n=34 Participants Brodalumab (210 mg) via subcutaneous injection using prefilled syringes given at Weeks 0, 1, 2, and every 2 weeks thereafter through and including Week 16.
Number of Participants With Psoriasis Area and Severity Index (PASI) Score Improvement PASI-75	26 Participants
Number of Participants With Psoriasis Area and Severity Index (PASI) Score Improvement PASI-90	17 Participants
Number of Participants With Psoriasis Area and Severity Index (PASI) Score Improvement PASI-100	11 Participants

SECONDARY outcome

Timeframe: 16 weeks

Number of adverse events as a measure of safety

Outcome measures

Outcome measures
Measure	Brodalumab n=39 Participants Brodalumab (210 mg) via subcutaneous injection using prefilled syringes given at Weeks 0, 1, 2, and every 2 weeks thereafter through and including Week 16.
Number of Adverse Events	6 events

Adverse Events

Brodalumab

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Brodalumab n=39 participants at risk Brodalumab (210 mg) via subcutaneous injection using prefilled syringes given at Weeks 0, 1, 2, and every 2 weeks thereafter through and including Week 16.
Eye disorders Corneal Ulcer	2.6% 1/39 • Number of events 1 • 16 weeks
Infections and infestations Tooth Abscess	2.6% 1/39 • Number of events 1 • 16 weeks
Immune system disorders Allergic Sinusitis	2.6% 1/39 • Number of events 1 • 16 weeks
Skin and subcutaneous tissue disorders Folliculitis	2.6% 1/39 • Number of events 1 • 16 weeks
Endocrine disorders Pre-Diabetes	2.6% 1/39 • Number of events 1 • 16 weeks
Musculoskeletal and connective tissue disorders Sciatica	2.6% 1/39 • Number of events 1 • 16 weeks

Additional Information

Dr. Mark Lebwohl

Icahn School of Medicine at Mount Sinai

Phone: 212-241-9728

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place