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LYS006

Phase 2

Inflammatory Acne | Small molecule | Dermatology |Novartis AG|Trials Updated: Aug 31, 2023

LYS006 development status

Highest phase Phase 2
Registered trials 3 across 1 sponsor since Feb 2019

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment66

FDA Designations

No designations recorded

LYS006 clinical trials

LYS006 · 1 trial · 1 indication

Phase 2 1
NCT03497897Study to Assess the Efficacy and Safety of LYS006 in Patients With Moderate to Severe Inflammatory AcneInflammatory Acne
COMPLETED66 Analytics
PHASE2COMPLETED
Study to Assess the Efficacy and Safety of LYS006 in Patients With Moderate to Severe Inflammatory Acne
Inflammatory AcneUnlock trial analytics

Study Endpoints

Primary Endpoints

Total Inflammatory Lesion Count
Week 12

Inflammatory facial lesion count included papules, pustules, and nodules. The natural log transformed inflammatory facial lesion count up to Week 12 was analyzed using a Bayesian mixed effect model for repeated measurements (MMRM). Values estimated from the model at Week 12 are presented in the table. Posterior geometric mean and 90% credible intervals in each group are presented.

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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
LYS006 20 mg BIDEXPERIMENTALLYS006, 20 mg, orally, twice daily (BID), for 12 weeks
LYS006 2 mg BIDEXPERIMENTALLYS006, 2 mg, orally, BID, for 12 weeks
Placebo BIDPLACEBO_COMPARATORMatching placebo, orally, BID, for 12 weeks

Interventions

NameTypeDescription
LYS006 20 mgDRUGLYS006 20 mg, capsules, oral administration, BID, for 12 weeks
LYS006 2 mgDRUGLYS006 2 mg, capsules, oral administration, BID, for 12 weeks
PlaceboDRUGMatching placebo, capsules, oral administration, BID, for 12 weeks
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Eligibility Criteria

Age Range18 Years to 45 Years
SexALL
Healthy VolunteersNo
Study Sites17

Inclusion criteria: * Male and female subjects aged 18 to 45 years of age inclusive, and otherwise in good health as determined by medical history, physical examination, vital signs, ECGs and laboratory tests at screening. * Body weight between 50 and 120 kg, both inclusive, at screening. * Patient...

Countries:United StatesCzechiaFranceGermanyHungaryNetherlands
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Competitive Landscape -Inflammatory Disorders 15 trials (matched to "Inflammatory Acne")

Top 1 of 2 competitors

CompanyTickerTrialsLead PhaseDrugs
Novo Nordisk A/S Sponsored ADR Class BNVO2PHASE3Ziltivekimab, Semaglutide
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Frequently asked questions about LYS006

What is LYS006?

LYS006 is an investigational small molecule drug developed by Novartis AG for the treatment of moderate to severe inflammatory acne. It is a Phase 2 clinical candidate that has been studied in a completed placebo-controlled trial. LYS006 is not yet approved for any indication.

What is LYS006 used for?

LYS006 is being developed for the treatment of moderate to severe inflammatory acne, a dermatological condition. It has been evaluated in a Phase 2 clinical trial in adult patients with this condition. The drug is investigational and has not received regulatory approval for any use.

Who makes LYS006?

LYS006 is developed by Novartis AG, which trades under the ticker symbol NVS. Novartis is the sponsor of the clinical program evaluating LYS006 in inflammatory acne.

What phase is LYS006 in?

LYS006 is in Phase 2 clinical development. A Phase 2 trial in moderate to severe inflammatory acne has been completed. The drug remains investigational and is not approved by the FDA or any other regulatory agency.

What clinical trials is LYS006 in?

LYS006 has been studied in one completed Phase 2 trial, NCT03497897, titled Study to Assess the Efficacy and Safety of LYS006 in Patients With Moderate to Severe Inflammatory Acne. The trial enrolled 66 patients across the United States, Czechia, France, Germany, Hungary, and the Netherlands.