Trial · NCT03975153
Guselkumab in the Treatment of Pityriasis Rubra Pilaris (PRP)
NCT03975153, Phase 2, Completed, Oregon Health and Science University; results first posted 2024-05-24
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Guselkumab in the Treatment of Pityriasis Rubra Pilaris (PRP). Trials, record NCT03975153. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03975153
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Guselkumab in the Treatment of Pityriasis Rubra Pilaris (PRP)
- NCT number
- NCT03975153
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 15 participants, actual
- Lead sponsor
- Oregon Health and Science University
- Conditions
- Pityriasis Rubra Pilaris
- Interventions
- guselkumab
- First posted
- 2019-06-05
- Last updated
- 2024-05-24
- Results first posted
- 2024-05-24
- Limitations and caveats
- Limitations of the study: open label design, small sample size, lack of validated outcomes measures for PRP, racial and ethnic homogeneity of the participants
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Change From Baseline Psoriasis Area and Severity Index (PASI) at Week-24 After Treatment With Guselkumab. | 24 weeks | 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. |
| Secondary | Proportion of Subjects Achieving a 4-point Improvement in Quality of Life Measured by the Dermatology Life Quality Index (DLQI) at Week-24. | 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. |
| Secondary | Proportion of Subjects With >50% Improvement With Psoriasis Area and Severity Index (PASI) at Week-24 Who Did Not Worsen at Week-36 | 36 weeks | 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. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mean Change From Baseline Psoriasis Area and Severity Index (PASI) at Week-24 After Treatment With Guselkumab. | 24 weeks | percent change from baseline PASI | MEAN | |
| SECONDARY | Proportion of Subjects Achieving a 4-point Improvement in Quality of Life Measured by the Dermatology Life Quality Index (DLQI) at Week-24. | 24 weeks | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Proportion of Subjects With >50% Improvement With Psoriasis Area and Severity Index (PASI) at Week-24 Who Did Not Worsen at Week-36 | 36 weeks | Only participants who achieved \>50% in PASI at week-24 are included in this analysis. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group3
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Mean Change From Baseline Psoriasis Area and Severity Index (PASI) at Week-24 After Treatment With Guselkumab. | Guselkumab Treatment | 61.8 | Full Range 21.3 to 100 | percent change from baseline PASI | |
| Proportion of Subjects Achieving a 4-point Improvement in Quality of Life Measured by the Dermatology Life Quality Index (DLQI) at Week-24. | Guselkumab Treatment | 11 | Participants | ||
| Proportion of Subjects With >50% Improvement With Psoriasis Area and Severity Index (PASI) at Week-24 Who Did Not Worsen at Week-36 | Guselkumab Treatment | 9 | Participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Guselkumab Treatment | 14 | |
| Overall Study | COMPLETED | Guselkumab Treatment | 12 | |
| Overall Study | NOT COMPLETED | Guselkumab Treatment | 2 |
Source ClinicalTrials.gov
Adverse events21
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Temporary PRP worsening | Skin and subcutaneous tissue disorders | Guselkumab Treatment | 1 | 12 | 1 |
| other | Ectropion | Eye disorders | Guselkumab Treatment | 1 | 12 | 1 |
| other | Elevated creatinine | Renal and urinary disorders | Guselkumab Treatment | 1 | 12 | 1 |
| other | Gastroenteritis | Gastrointestinal disorders | Guselkumab Treatment | 1 | 12 | 1 |
| other | Weight loss | Metabolism and nutrition disorders | Guselkumab Treatment | 1 | 12 | 1 |
| other | Ground level fall | Social circumstances | Guselkumab Treatment | 1 | 12 | 1 |
| other | Injection site reaction | Skin and subcutaneous tissue disorders | Guselkumab Treatment | 1 | 12 | 1 |
| other | Scalp pustules | Skin and subcutaneous tissue disorders | Guselkumab Treatment | 1 | 12 | 1 |
| other | Pulmonary nodule | Respiratory, thoracic and mediastinal disorders | Guselkumab Treatment | 1 | 12 | 1 |
| other | False-positive hyperkalmia | Blood and lymphatic system disorders | Guselkumab Treatment | 1 | 12 | 1 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Guselkumab Treatment | 1 | 12 |
| Total, other adverse events | Guselkumab Treatment | 8 | 12 |
| Total, serious adverse events | Guselkumab Treatment | 1 | 12 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 38598229 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03975153
GET https://conductscience.org/api/trials/v1/NCT03975153/events?page=2