Phase 2
Completed N=331
The Safety, Efficacy and Pharmacokinetics of ARQ-151 Cream in Subjects With Chronic Plaque Psoriasis
Source: ClinicalTrials.gov NCT03638258 ↗Enrolled (actual)
331
Serious AEs
1.2%
Results posted
Aug 2022
Primary outcomePrimary: Percentage of Participants With an Investigator Global Assessment (IGA) Score of 'Clear' or 'Almost Clear' at Week 6 — 28.0; 22.8; 8.3 percentage of participants — p=<0.001
Summary
This is a parallel group, double blind, vehicle-controlled study in which roflumilast (ARQ-151) cream 0.3%, roflumilast cream 0.15%, or vehicle cream is applied once daily (QD) for 84 days to subjects with chronic plaque psoriasis involving between 2 and 20% body surface area.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With an Investigator Global Assessment (IGA) Score of 'Clear' or 'Almost Clear' at Week 6 |
28.0; 22.8; 8.3 | <0.001 sig |
| SECONDARY Percentage of Participants With an Investigator Global Assessment (IGA) Score of 'Clear' or 'Almost Clear' |
14.5; 9.0; 4.4; 37.9; 30.6; 11.9 | 0.015 sig |
| SECONDARY Change From Baseline in Modified Psoriasis Area Severity Index (mPASI) Score |
-40.08; -47.32; -18.01; -53.15; -59.73; -16.42 | <0.001 sig |
| SECONDARY Percent Change From Baseline in Body Surface Area (BSA) Affected |
-21.74; -23.25; -5.33; -34.88; -33.41; -8.19 | <0.001 sig |
| SECONDARY Percentage of Participants With an Investigator Global Assessment (IGA) Score of 'Clear' or 'Almost Clear' Plus a 2-Grade Improvement From Baseline |
10.0; 6.9; 4.4; 23.9; 17.4; 8.0 | 0.116 |
| SECONDARY Percentage of Participants With an Intertriginous Area Investigator Global Assessment (I-IGA) Score of 'Clear' or 'Almost Clear' Who Had at Least Mild Lesions at Baseline |
46.6; 43.8; 17.6; 73.4; 43.7; 29.4 | 0.086 |
| SECONDARY Change From Baseline in Worst Itch-Numeric Rating Scale (WI-NRS) Pruritus Score |
-2.8; -1.9; -1.1; -3.3; -2.6; -1.3 | <0.001 sig |
| SECONDARY Percentage of Participants With Baseline Worst Itch-Numeric Rating Scale (WI-NRS) Pruritus Score ≥6 Who Experienced a 4-point Reduction |
50.9; 35.4; 24.9; 52.8; 57.0; 34.5 | 0.002 sig |
| SECONDARY Percentage of Participants Achieving a Modified Psoriasis Area Severity Index-75 (mPASI-75) Compared to Baseline |
13.3; 7.6; 10.5; 24.1; 22.2; 9.6 | 0.527 |
| SECONDARY Percentage of Participants Achieving a Modified Psoriasis Area Severity Index-90 (mPASI-90) Compared to Baseline |
6.0; 1.3; 2.3; 14.3; 2.3; 3.2 | 0.188 |
| SECONDARY Change From Baseline in Psoriasis Symptom Diary (PSD) Total Score |
-32.7; -32.7; -22.9; -37.8; -38.0; -24.6 | 0.002 sig |
| SECONDARY Change From Baseline in Itch-Related Sleep Loss Numeric Rating Scale (NRS) Score |
-1.1; -1.2; -1.0; -1.5; -1.3; -0.9 | 0.184 |
| SECONDARY Change From Baseline in Dermatology Life Quality Index (DLQI) Score |
-2.2; -2.3; -1.9; -2.6; -3.1; -1.8 | 0.255 |
| SECONDARY Responses to Individual Questions of the Psoriasis Symptom Diary (PSD) |
3.0; 3.3; 4.2; 1.8; 1.6; 2.6 | — |
Eligibility Criteria
Inclusion Criteria
- Participants legally competent to sign and give informed consent
- Males and females ages 18 years and older (inclusive)
- Clinical diagnosis of psoriasis vulgaris of at least 6 months duration as determined by the Investigator
- Females of childbearing potential (FOCBP) must have a negative urine pregnancy test at Screening (Visit 1) and Baseline (Visit 2). In addition, sexually active FOCBP must agree to use at least one form of highly effective contraception throughout the trial.
- In good health as judged by the Investigator, based on medical history, physical examination, serum chemistry labs, hematology values, and urinalysis.
- Subjects are considered reliable and capable of adhering to the Protocol and visit schedule, according to the judgment of the Investigator.
Exclusion Criteria
- Planned excessive exposure of treated area(s) to either natural or artificial sunlight or tanning bed.
- Females who are pregnant, wishing to become pregnant during the study, or are breast-feeding.
- Previous treatment with roflumilast cream or its active ingredient
- Subjects with any serious medical condition or laboratory abnormality that would prevent study participation or place the subject at significant risk, as determined by the Investigator.
- Subjects with a history of chronic alcohol or drug abuse within 6 months of initiation of study medication.
- Subjects who are unable to communicate, read or understand the local language, or who display another condition, which in the Investigator's opinion, makes them unsuitable for clinical study participation.
Data sourced from ClinicalTrials.gov (NCT03638258). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.