Trial Outcomes & Findings for Ixekizumab in the Treatment of Pityriasis Rubra Pilaris (PRP) (NCT NCT03485976)

Last Updated: 2020-07-01

Results Overview

Clinical improvement will be measured by the Psoriasis Area and Severity Index (PASI) score. PASI is a scale that measures the severity (redness, scale, and elevation) of each body surface area of skin involved in psoriasis (a disease that has some similarities with PRP). Redness, scale, and elevation are each scored on a 0-4 point scale, added together, and multiplied by each body surface area involved (head and neck, trunk, upper limbs, lower limbs). The maximum score is 72 which would indicate the worst disease over every surface of someone's body. A scale of zero would indicate normal skin.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

12 participants

Primary outcome timeframe

24 weeks

Results posted on

2020-07-01

Participant Flow

Participant milestones

Participant milestones
Measure	Ixekizumab Treatment Arm Ixekizumab 160 mg subcutaneous injection at week 0, followed by 80 mg subcutaneous injections at week 2, 4, 6, 8, 10, 12, 16, and 20 Ixekizumab: Treatment at the FDA-approved psoriasis dosing
Overall Study STARTED	12
Overall Study COMPLETED	11
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Ixekizumab in the Treatment of Pityriasis Rubra Pilaris (PRP)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ixekizumab Treatment Arm n=12 Participants Ixekizumab 160 mg subcutaneous injection at week 0, followed by 80 mg subcutaneous injections at week 2, 4, 6, 8, 10, 12, 16, and 20 Ixekizumab: Treatment at the FDA-approved psoriasis dosing
Age, Continuous	44.8 years n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	12 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	12 participants n=5 Participants
Body Mass Index (BMI)	28.0 kg/m^2 n=5 Participants
PRP Subtype Classic adult (Type I PRP)	6 Participants n=5 Participants
PRP Subtype Atypical adult (Type II PRP)	5 Participants n=5 Participants
PRP Subtype Classic juvenile (Type III PRP)	1 Participants n=5 Participants
Psoriasis Assessment and Severity Index (PASI) score	24.8 units on a scale n=5 Participants
Physician Global Assessment (PGA) score Clear (0)	0 Participants n=5 Participants
Physician Global Assessment (PGA) score Almost clear (1)	0 Participants n=5 Participants
Physician Global Assessment (PGA) score Mild (2)	0 Participants n=5 Participants
Physician Global Assessment (PGA) score Moderate (3)	9 Participants n=5 Participants
Physician Global Assessment (PGA) score Severe (4)	3 Participants n=5 Participants
Dermatology Life Quality Index (DLQI) score	19 units on a scale n=5 Participants
Itch Numerical Rating Score (NRS)	7 units on a scale n=5 Participants
Pain Numerical Rating Score (NRS)	6 units on a scale n=5 Participants
Age at PRP diagnosis	43.7 years n=5 Participants
Duration of PRP symptoms prior to trial enrollment	11.9 months n=5 Participants
Previous systemic therapy Treatment naive	1 participants n=5 Participants
Previous systemic therapy Prior systemic therapy	11 participants n=5 Participants
Previous systemic therapy Prior methotrexate	6 participants n=5 Participants
Previous systemic therapy Prior systemic retinoid	7 participants n=5 Participants
Previous systemic therapy Prior biologic therapy	4 participants n=5 Participants

PRIMARY outcome

Timeframe: 24 weeks

Population: Mean improvement in PASI from baseline to week-24

Outcome measures

Outcome measures
Measure	Ixekizumab Treatment Arm n=12 Participants Ixekizumab 160 mg subcutaneous injection at week 0, followed by 80 mg subcutaneous injections at week 2, 4, 6, 8, 10, 12, 16, and 20 Ixekizumab: Treatment at the FDA-approved psoriasis dosing
Clinical Improvement in PRP Severity and Body Surface Area	15.2 units on a scale Standard Error 2.1

SECONDARY outcome

Timeframe: 24 weeks

Quality of life will be measured by the Dermatology Life Quality Index (DLQI). There are 10 questions covering symptoms, embarrassment, shopping and home care, clothes, social and leisure, sport, work or study, close relationships, sex, and treatment. Each question refers to the impact of PRP on the patient's life over the previous week. The highest score is 30 and would indicate a maximum (negative) impact on quality of life. A score of zero would indicate no impact on quality of life.

Outcome measures

Outcome measures
Measure	Ixekizumab Treatment Arm n=12 Participants Ixekizumab 160 mg subcutaneous injection at week 0, followed by 80 mg subcutaneous injections at week 2, 4, 6, 8, 10, 12, 16, and 20 Ixekizumab: Treatment at the FDA-approved psoriasis dosing
Improvement in Quality of Life	9.5 units on a scale Standard Error 2.5

SECONDARY outcome

Timeframe: 24 weeks

Itch will be measured using a numeric rating scale from 0 (no itch) to 10 (worst itch imaginable).

Outcome measures

Outcome measures
Measure	Ixekizumab Treatment Arm n=12 Participants Ixekizumab 160 mg subcutaneous injection at week 0, followed by 80 mg subcutaneous injections at week 2, 4, 6, 8, 10, 12, 16, and 20 Ixekizumab: Treatment at the FDA-approved psoriasis dosing
Improvement in Itch	3.6 units on a scale Standard Error 0.8

Adverse Events

Ixekizumab Treatment Arm

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Ixekizumab Treatment Arm n=12 participants at risk Ixekizumab 160 mg subcutaneous injection at week 0, followed by 80 mg subcutaneous injections at week 2, 4, 6, 8, 10, 12, 16, and 20 Ixekizumab: Treatment at the FDA-approved psoriasis dosing
Infections and infestations Upper respiratory tract infection	33.3% 4/12 • Number of events 4 • 24-weeks
Gastrointestinal disorders Gastrointestinal upset	8.3% 1/12 • Number of events 1 • 24-weeks
Skin and subcutaneous tissue disorders Injection site reaction	8.3% 1/12 • Number of events 1 • 24-weeks
Skin and subcutaneous tissue disorders Temporary worsening of PRP	8.3% 1/12 • Number of events 1 • 24-weeks
Infections and infestations Otitis externa	8.3% 1/12 • Number of events 1 • 24-weeks
Skin and subcutaneous tissue disorders Ingrown nail	8.3% 1/12 • Number of events 1 • 24-weeks
Eye disorders Glaucoma	8.3% 1/12 • Number of events 1 • 24-weeks
Cardiac disorders Non-specific chest pain (resolved without intervention)	8.3% 1/12 • Number of events 1 • 24-weeks
Blood and lymphatic system disorders Mild leukopenia	8.3% 1/12 • Number of events 1 • 24-weeks
Blood and lymphatic system disorders Eosinophilia	8.3% 1/12 • Number of events 1 • 24-weeks
Skin and subcutaneous tissue disorders Cutaneous atrophy associated with corticosteroid use	8.3% 1/12 • Number of events 1 • 24-weeks
Infections and infestations Bacterial vaginosis	8.3% 1/12 • Number of events 1 • 24-weeks

Additional Information

Teri Greiling, MD, PhD

Oregon Health & Science University, Department of Dermatology

Phone: 503-494-8452

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place