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LYS006

Phase 2

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

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

Clinical trial landscape

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 8 trials (matched to "Inflammatory Acne")

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Frequently asked questions about LYS006

What is LYS006 used for?

LYS006 is an investigational small molecule being developed for the treatment of moderate to severe inflammatory acne. It is a dermatology therapy that has been studied in a Phase 2 clinical trial to assess its efficacy and safety in patients with this condition.

Who makes LYS006?

LYS006 is being developed by Novartis AG, a multinational pharmaceutical company traded on the New York Stock Exchange under the ticker symbol NVS. The company has conducted clinical research to evaluate the drug's potential in treating inflammatory acne.

What phase is LYS006 in?

LYS006 is in Phase 2 clinical development. It has completed a Phase 2 trial that evaluated its efficacy and safety in patients with moderate to severe inflammatory acne. The drug is investigational and has not been approved by regulatory authorities.

What clinical trials is LYS006 in?

LYS006 has been studied in one completed Phase 2 clinical trial, identified as NCT03497897. This randomized, double-blind, placebo-controlled study enrolled 66 participants with moderate to severe inflammatory acne across the United States, Czechia, France, Germany, Hungary, and the Netherlands.

Is LYS006 the same as any other drug?

No alternative names for LYS006 have been disclosed in the available clinical trial information. The drug is identified solely by its investigational code name LYS006 in the completed Phase 2 study for inflammatory acne.