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secukinumab Q4W

Phase 2

Lichen Planus: Cutaneous Lichen Planus, Mucosal Lichen Planus and Lichen Planopilaris | Small molecule | Dermatology |Novartis AG|Last Updated: Aug 22, 2023

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment111

FDA Designations

No designations recorded

Clinical trial landscape

secukinumab Q4W · 1 trial · 1 indication

Phase 2 1
NCT04300296PoC Study to Evaluate the Efficacy and Safety of Secukinumab 300 mg in Patients With Lichen PlanusLichen Planus: Cutaneous Lichen Planus, Mucosal Lichen Planus and Lichen Planopilaris
COMPLETED111 Analytics
PHASE2COMPLETED
PoC Study to Evaluate the Efficacy and Safety of Secukinumab 300 mg in Patients With Lichen Planus
Lichen Planus: Cutaneous Lichen Planus, Mucosal Lichen Planus and Lichen PlanopilarisUnlock trial analytics

Study Endpoints

Primary Endpoints

Response Rate of Investigator Global Assessment (IGA) Score of 2 or Lower at Week 16 for CLP, MLP and LPP
Baseline up to week 16

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.

Secondary Endpoints

Number (%) of Subjects With IGA ≤ 2 Response, IGA ≥2 Points Improvement Response, and IGA 0 or 1 Response by Visit - CLP Cohort (BOCF)- Entire Treatment Period (FAS)
Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 28, and 32
Number (%) of Subjects With IGA ≤ 2 Response, IGA ≥2 Points Improvement Response, and IGA 0 or 1 Response by Visit - MLP Cohort (BOCF)- Entire Treatment Period (FAS)
Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 28, and 32
Number (%) of Subjects With IGA ≤ 2 Response, IGA ≥2 Points Improvement Response, and IGA 0 or 1 Response by Visit - LPP Cohort (BOCF)- Entire Treatment Period (FAS)
Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 28, and 32
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Cutaneous lichen planus secukinumab 300mg Q4WEXPERIMENTALSecukinumab 300 mg every 4 weeks provided in pre-filled syringe in cutaneous lichen planus patients
Cutaneous lichen planus placeboPLACEBO_COMPARATORPlacebo in 1ml PFS in cutaneous lichen patients
Mucosal lichen planus secukinumab 300 mg Q4WEXPERIMENTALSecukinumab 300 mg every 4 weeks provided in pre-filled syringe in mucosal lichen planus patients.
Mucosal lichen planus placeboPLACEBO_COMPARATORPlacebo 1 ml PFS in mucosal lichen planus patients
Lichen planopilaris secukinumab 300 mg Q4WEXPERIMENTALSecukinumab 300 mg every 4weeks provided in pre-filled syringe in lichen planopilaris patients.
Lichen planopilaris placeboPLACEBO_COMPARATORPlacebo in 1ml PFS in lichen planopilaris patients
Cutaneous lichen planus placebo to secukinumab 300 mg Q2WEXPERIMENTALNon responder patients on placebo in TP 1 received secukinumab 300 mg Q2W in TP 2
Mucosal lichen planus placebo to secukinumab 300 mg Q2WEXPERIMENTALNon responder patients on placebo in TP 1 received secukinumab 300 mg Q2W in TP 2
Lichen planopilaris placebo to secukinumab 300 mg Q2WEXPERIMENTALNon responder patients on placebo in TP 1 received secukinumab 300 mg Q2W in TP 2

Interventions

NameTypeDescription
secukinumab 300 mg Q4WDRUGsecukinumab 300 mg administered every four weeks (Q4W) via a pre-filled syringe.
secukinumab 300 mg Q2WDRUGsecukinumab 300 mg administered every two weeks (Q2W) via a pre-filled syringe.
PlaceboOTHERMatching placebo administered via a pre-filled syringe
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites35

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...

Countries:United StatesFranceGermany
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Frequently asked questions about secukinumab Q4W

What is secukinumab Q4W used for?

Secukinumab Q4W is being investigated for the treatment of lichen planus, specifically cutaneous lichen planus, mucosal lichen planus, and lichen planopilaris. It is a small molecule developed by Novartis AG for use in dermatology. The drug is currently in Phase 2 clinical development for these conditions.

What does secukinumab Q4W target?

Secukinumab Q4W is a small molecule, but its specific molecular target has not been disclosed in the available information. The drug is being studied for its efficacy and safety in patients with lichen planus, a chronic inflammatory condition affecting the skin and mucous membranes.

Who makes secukinumab Q4W?

Secukinumab Q4W is developed by Novartis AG, a multinational pharmaceutical company listed on the stock exchange under the ticker NVS. The company is conducting clinical trials to evaluate the drug's potential in treating various forms of lichen planus.

What phase is secukinumab Q4W in?

Secukinumab Q4W is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still undergoing clinical trials to assess its safety and efficacy in patients with lichen planus.

What clinical trials is secukinumab Q4W in?

Secukinumab Q4W is being studied in a Phase 2 clinical trial with the identifier NCT04300296. This trial, titled 'PoC Study to Evaluate the Efficacy and Safety of Secukinumab 300 mg in Patients With Lichen Planus,' has been completed. It enrolled 111 participants across the United States, France, and Germany.

Is secukinumab Q4W the same as secukinumab?

Secukinumab Q4W is a specific dosing regimen of secukinumab, administered every four weeks. The drug is being investigated for lichen planus, and the clinical trial NCT04300296 evaluated a 300 mg dose given on this schedule. The drug is developed by Novartis AG.