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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04300296 | PoC Study to Evaluate the Efficacy and Safety of Secukinumab 300 mg in Patients With Lichen Planus | PHASE2 | COMPLETED | 111 | — | — | Jul 27, 2020 | May 3, 2022 | Aug 22, 2023 | 35 | United States, France +1 |
Number of treatment responders at week 16, where response is defined as an Investigator's Global Assessment (IGA) score of 2 or lower at Week 16. IGA is measured on a scale from 0 - 4 with 0 = Clear, 1 = Minimal; 2 = Mild; 3 = Moderate; and 4 = Severe with 0 being best score and 4 being worst score. CLP=Cutaneous lichen planus, MLP=Mucosal lichen planus, LPP=Lichen planopilaris. Posterior median and 95% credible interval (instead of 95% confidence interval) were derived using Bayesian method based on beta-binomial model.
| Arm | Type | Description |
|---|---|---|
| Cutaneous lichen planus secukinumab 300mg Q4W | EXPERIMENTAL | Secukinumab 300 mg every 4 weeks provided in pre-filled syringe in cutaneous lichen planus patients |
| Cutaneous lichen planus placebo | PLACEBO_COMPARATOR | Placebo in 1ml PFS in cutaneous lichen patients |
| Mucosal lichen planus secukinumab 300 mg Q4W | EXPERIMENTAL | Secukinumab 300 mg every 4 weeks provided in pre-filled syringe in mucosal lichen planus patients. |
| Mucosal lichen planus placebo | PLACEBO_COMPARATOR | Placebo 1 ml PFS in mucosal lichen planus patients |
| Lichen planopilaris secukinumab 300 mg Q4W | EXPERIMENTAL | Secukinumab 300 mg every 4weeks provided in pre-filled syringe in lichen planopilaris patients. |
| Lichen planopilaris placebo | PLACEBO_COMPARATOR | Placebo in 1ml PFS in lichen planopilaris patients |
| Cutaneous lichen planus placebo to secukinumab 300 mg Q2W | EXPERIMENTAL | Non responder patients on placebo in TP 1 received secukinumab 300 mg Q2W in TP 2 |
| Mucosal lichen planus placebo to secukinumab 300 mg Q2W | EXPERIMENTAL | Non responder patients on placebo in TP 1 received secukinumab 300 mg Q2W in TP 2 |
| Lichen planopilaris placebo to secukinumab 300 mg Q2W | EXPERIMENTAL | Non responder patients on placebo in TP 1 received secukinumab 300 mg Q2W in TP 2 |
| Name | Type | Description |
|---|---|---|
| secukinumab 300 mg Q4W | DRUG | secukinumab 300 mg administered every four weeks (Q4W) via a pre-filled syringe. |
| secukinumab 300 mg Q2W | DRUG | secukinumab 300 mg administered every two weeks (Q2W) via a pre-filled syringe. |
| Placebo | OTHER | Matching placebo administered via a pre-filled syringe |
Inclusion Criteria: 1. Written informed consent must be obtained before any assessment is performed. 2. Female and male patients ≥ 18 years of age. 3. Subjects must have biopsy-confirmed forms of cutaneous lichen planus (CLP), mucosal lichen planus (MLP), or active lichen planopilaris (LPP) eligibl...