Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04202679 | Study of Dupilumab for the Treatment of Patients With Prurigo Nodularis, Inadequately Controlled on Topical Prescription Therapies or When Those Therapies Are Not Advisable (PRIME2) | PHASE3 | COMPLETED | 160 | — | — | Jan 16, 2020 | Nov 22, 2021 | Sep 17, 2025 | 57 | United States, Canada +9 |
| NCT04183335 | Study of Dupilumab for the Treatment of Patients With Prurigo Nodularis, Inadequately Controlled on Topical Prescription Therapies or When Those Therapies Are Not Advisable (LIBERTY-PN PRIME) | PHASE3 | COMPLETED | 151 | — | — | Dec 12, 2019 | Feb 3, 2022 | Sep 17, 2025 | 63 | United States, Argentina +6 |
WI-NRS is a validated measure of itch severity. Participants were asked daily to rate the intensity of their worst pruritus (itch) over the past 24 hours, using a 11-point scale ranging from 0 (no itch) to 10 (worst imaginable itch). Higher scores indicated more severity. Percentage of participants with \>=4 points improvement (reduction) from baseline in WI-NRS scores at Week 12 is reported in this outcome measure.
WI-NRS is a validated measure of itch severity. Participants were asked daily to rate the intensity of their worst pruritus (itch) over the past 24 hours, using a 11-point scale ranging from 0 (no itch) to 10 (worst imaginable itch). Higher scores indicated more severity. Percentage of participants with improvement (reduction) in WI-NRS scores by \>=4 points from Baseline to Week 24 is reported in this outcome measure.
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Participants received placebo matched to dupilumab 600 milligrams (mg) (loading dose), subcutaneously (SC) on Day 1 followed by placebo matched to dupilumab 300 mg once every 2 weeks (q2w) for 24 weeks added to background therapy of topical corticosteroids/topical calcineurin inhibitors (TCS/TCI) at stable dose. |
| Dupilumab 300 mg Q2W | EXPERIMENTAL | Participants received dupilumab at a loading dose of 600 mg, SC on Day 1 followed by dupilumab 300 mg q2w for 24 weeks added to background therapy of TCS/TCI at stable dose. |
| Dupilumab | EXPERIMENTAL | Participants received dupilumab at a loading dose of 600 milligrams (mg), subcutaneously (SC) on Day 1 followed by dupilumab 300 mg once every 2 weeks (q2w) for 24 weeks added to background therapy of topical corticosteroids/topical calcineurin inhibitors (TCS/TCI) at stable dose. |
| Name | Type | Description |
|---|---|---|
| Dupilumab SAR231893 | DRUG | Pharmaceutical form:Injection solution Route of administration: Subcutaneous |
| Placebo | DRUG | Pharmaceutical form:Injection solution Route of administration: Subcutaneous |
| Moisturizers | DRUG | Pharmaceutical form: Route of administration: Topical |
| Low to medium potent topical corticosteroids | DRUG | Pharmaceutical form: Route of administration: Topical |
| Topical calcineurin inhibitors | DRUG | Pharmaceutical form: Route of administration: Topical |
Inclusion criteria : Must be 18 to 80 years of age, at the time of signing the informed consent. With a clinical diagnosis of PN defined by all of the following: * Diagnosed by a dermatologist for at least 3 months before the Screening visit. * On the Worst Itch Numeric Rating Scale (WI-NRS) rang...