Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
secukinumab Q4W · 1 trial · 1 indication
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...
Secukinumab Q4W has been studied in lichen planus, including cutaneous lichen planus, mucosal lichen planus, and lichen planopilaris. It is an investigational use for this dermatologic condition and has been evaluated in a Phase 2 proof-of-concept trial. It is not approved for lichen planus.
Secukinumab Q4W targets IL17A. It is a monoclonal antibody that acts as an inhibitor of this cytokine. By binding to IL17A, the drug is designed to interfere with the inflammatory signaling pathway implicated in lichen planus.
Secukinumab Q4W is being developed by Novartis AG, which trades under the ticker NVS. Novartis conducted the Phase 2 proof-of-concept study evaluating secukinumab 300 mg in patients with lichen planus.
Secukinumab Q4W is in Phase 2 development for lichen planus. The single trial evaluating it has been completed. It is an investigational therapy and is not approved for the treatment of lichen planus or any of its subtypes.
Secukinumab Q4W has been evaluated in one completed Phase 2 trial, NCT04300296, titled a proof-of-concept study to evaluate the efficacy and safety of secukinumab 300 mg in patients with lichen planus. The trial enrolled 111 patients across the United States, France, and Germany.