Trial Outcomes & Findings for Guselkumab in the Treatment of Pityriasis Rubra Pilaris (PRP) (NCT NCT03975153)

NCT ID: NCT03975153

Last Updated: 2024-05-24

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

15 participants

Primary outcome timeframe

24 weeks

Results posted on

2024-05-24

Participant Flow

Participant milestones

Participant milestones
Measure	Guselkumab Treatment Treatment with guselkumab for 20 weeks guselkumab: Treatment at the FDA-approved psoriasis dosing for 20 weeks
Overall Study STARTED	14
Overall Study COMPLETED	12
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Guselkumab in the Treatment of Pityriasis Rubra Pilaris (PRP)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Guselkumab Treatment n=12 Participants Treatment with guselkumab for 20 weeks guselkumab: Treatment at the FDA-approved psoriasis dosing for 20 weeks
Age, Continuous	56.5 years STANDARD_DEVIATION 18.7 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	12 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 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	11 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
Psoriasis Area and Severity Index	30.6 units on a scale STANDARD_DEVIATION 11.4 • n=5 Participants
Dermatology Life Quality Index	20.1 units on a scale STANDARD_DEVIATION 6.8 • n=5 Participants
Itch numeric rating scale	6.9 units on a scale STANDARD_DEVIATION 2.2 • n=5 Participants

PRIMARY outcome

Timeframe: 24 weeks

Outcome measures

Outcome measures
Measure	Guselkumab Treatment n=12 Participants Treatment with guselkumab for 20 weeks guselkumab: Treatment at the FDA-approved psoriasis dosing for 20 weeks
Mean Change From Baseline Psoriasis Area and Severity Index (PASI) at Week-24 After Treatment With Guselkumab.	61.8 percent change from baseline PASI Interval 21.3 to 100.0

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. For inflammatory skin conditions, a 4-point improvement in DLQI score is considered clinically important.

Outcome measures

Outcome measures
Measure	Guselkumab Treatment n=12 Participants Treatment with guselkumab for 20 weeks guselkumab: Treatment at the FDA-approved psoriasis dosing for 20 weeks
Proportion of Subjects Achieving a 4-point Improvement in Quality of Life Measured by the Dermatology Life Quality Index (DLQI) at Week-24.	11 Participants

SECONDARY outcome

Timeframe: 36 weeks

Population: Only participants who achieved \>50% in PASI at week-24 are included in this analysis.

PASI measures the appearance of the skin based on erythema, scale, and elevation, multiplied by body surface area. 0 indicates completely clear skin. 72 is the maximum value, indicating the worst severity. A score of 11 or higher is considered severe disease. Trial participants who had a decrease in PASI by \>50% from week-0 to week-24 were included in this analysis. Participants did not receive any additional doses of guselkumab after week-20, and PASI score at week-36 was calculated to assess for sustained remission.

Outcome measures

Outcome measures
Measure	Guselkumab Treatment n=9 Participants Treatment with guselkumab for 20 weeks guselkumab: Treatment at the FDA-approved psoriasis dosing for 20 weeks
Proportion of Subjects With >50% Improvement With Psoriasis Area and Severity Index (PASI) at Week-24 Who Did Not Worsen at Week-36	9 Participants

Adverse Events

Guselkumab Treatment

Serious events: 1 serious events

Other events: 8 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Guselkumab Treatment n=12 participants at risk Treatment with guselkumab for 20 weeks guselkumab: Treatment at the FDA-approved psoriasis dosing for 20 weeks
Cardiac disorders Cholecystitis leading to myocardial infarction and death	8.3% 1/12 • 36 weeks

Other adverse events

Other adverse events
Measure	Guselkumab Treatment n=12 participants at risk Treatment with guselkumab for 20 weeks guselkumab: Treatment at the FDA-approved psoriasis dosing for 20 weeks
Skin and subcutaneous tissue disorders Temporary PRP worsening	8.3% 1/12 • Number of events 1 • 36 weeks
Eye disorders Ectropion	8.3% 1/12 • Number of events 1 • 36 weeks
Renal and urinary disorders Elevated creatinine	8.3% 1/12 • Number of events 1 • 36 weeks
Gastrointestinal disorders Gastroenteritis	8.3% 1/12 • Number of events 1 • 36 weeks
Metabolism and nutrition disorders Weight loss	8.3% 1/12 • Number of events 1 • 36 weeks
Social circumstances Ground level fall	8.3% 1/12 • Number of events 1 • 36 weeks
Skin and subcutaneous tissue disorders Injection site reaction	8.3% 1/12 • Number of events 1 • 36 weeks
Skin and subcutaneous tissue disorders Scalp pustules	8.3% 1/12 • Number of events 1 • 36 weeks
Respiratory, thoracic and mediastinal disorders Pulmonary nodule	8.3% 1/12 • Number of events 1 • 36 weeks
Blood and lymphatic system disorders False-positive hyperkalmia	8.3% 1/12 • Number of events 1 • 36 weeks
Infections and infestations COVID19 infection	8.3% 1/12 • Number of events 1 • 36 weeks
Endocrine disorders Type 2 diabetes	8.3% 1/12 • Number of events 1 • 36 weeks
Nervous system disorders Bell's palsy	8.3% 1/12 • Number of events 1 • 36 weeks
Ear and labyrinth disorders Otitis externa	8.3% 1/12 • Number of events 1 • 36 weeks
Immune system disorders Leukocytosis	8.3% 1/12 • Number of events 1 • 36 weeks
Infections and infestations Herpes zoster	8.3% 1/12 • Number of events 1 • 36 weeks
Skin and subcutaneous tissue disorders Allergic contact dermatitis	8.3% 1/12 • Number of events 1 • 36 weeks
General disorders Fall due to plantar fissures	8.3% 1/12 • Number of events 1 • 36 weeks
Injury, poisoning and procedural complications Motor vehicle accident	8.3% 1/12 • Number of events 1 • 36 weeks
Skin and subcutaneous tissue disorders Ruptured blister	8.3% 1/12 • Number of events 1 • 36 weeks

Additional Information

Teri Greiling, MD, PhD, FAAD

Oregon Health & Science University

Phone: 503-494-3376

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place