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NCT03497897

Study to Assess the Efficacy and Safety of LYS006 in Patients With Moderate to Severe Inflammatory Acne

Completed Phase 2 Results posted Last updated 31 August 2023
What this trial tests

Phase 2 trial testing LYS006 20 mg in Inflammatory Acne in 66 participants. Completed in 9 March 2022.

Timeline
10 September 2018
Primary endpoint
24 February 2022
9 March 2022

Quick facts

Lead sponsorNovartis Pharmaceuticals
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposetreatment
Enrollment66
Start date10 September 2018
Primary completion24 February 2022
Estimated completion9 March 2022
Sites17 locations across France, Netherlands, Germany, Hungary, United States, Czechia

Drugs / interventions tested

Conditions studied

Sponsor

Novartis Pharmaceuticals — full company profile →

Who can join

Adults 18 to 45, any sex, with Inflammatory Acne. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Total Inflammatory Lesion Count Primary · 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.

GroupValue95% CI
LYS006 20 mg BID18.5514.16 – 24.32
LYS006 2 mg BID24.5116.35 – 36.94
Placebo BID20.0415.42 – 26.13

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 128 days. Reporting threshold: 2%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

LYS006 20 mg BID
Serious: 0/26 (0%)
Deaths: 0/26
LYS006 2 mg BID
Serious: 0/11 (0%)
Deaths: 0/11
Placebo BID
Serious: 0/29 (0%)
Deaths: 0/29
Total
Serious: 0/66 (0%)
Deaths: 0/66
Other adverse events (58 terms — click to expand)

ReactionSystemLYS006 20 mg BIDLYS006 2 mg BIDPlacebo BIDTotal
NasopharyngitisInfections and infestations
Blood creatine phosphokinase increasedInvestigations
Crystal urine presentInvestigations
HeadacheNervous system disorders
Urinary tract infectionInfections and infestations
Urine protein/creatinine ratio increasedInvestigations
NauseaGastrointestinal disorders
VomitingGastrointestinal disorders
Abdominal painGastrointestinal disorders
Abdominal pain upperGastrointestinal disorders
ConstipationGastrointestinal disorders
Haematocrit increasedInvestigations
Haemoglobin increasedInvestigations
Protein urine presentInvestigations
EpistaxisRespiratory, thoracic and mediastinal disorders
HaemoglobinaemiaBlood and lymphatic system disorders
PolycythaemiaBlood and lymphatic system disorders
TinnitusEar and labyrinth disorders
DiarrhoeaGastrointestinal disorders
FlatulenceGastrointestinal disorders
FatigueGeneral disorders
Influenza like illnessGeneral disorders
OedemaGeneral disorders
AcarodermatitisInfections and infestations
BronchitisInfections and infestations
COVID-19Infections and infestations
CystitisInfections and infestations
Gastrointestinal infectionInfections and infestations
Genital infection fungalInfections and infestations
GingivitisInfections and infestations
Otitis mediaInfections and infestations
SinusitisInfections and infestations
UrethritisInfections and infestations
Vulvovaginal mycotic infectionInfections and infestations
Muscle strainInjury, poisoning and procedural complications
Procedural painInjury, poisoning and procedural complications
Skin abrasionInjury, poisoning and procedural complications
SunburnInjury, poisoning and procedural complications
Albumin urine presentInvestigations
Aspartate aminotransferase increasedInvestigations

Data from ClinicalTrials.gov NCT03497897 adverse events section.

Sponsor's own description

The main purpose of this study is to assess preliminary efficacy and safety of LYS006 in patients with moderate to severe inflammatory acne and to determine if LYS006 has an adequate clinical profile for further clinical development.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. New perspectives on the treatment of hidradenitis suppurativa.
    Amat-Samaranch V, Agut-Busquet E, Vilarrasa E, Puig L. · · 2021 · cited 47× · PMID 34840709 · DOI 10.1177/20406223211055920
  2. Current Status of the Use of Multifunctional Enzymes as Anti-Cancer Drug Targets.
    Teixeira CSS, Sousa SF. · · 2021 · cited 10× · PMID 35056904 · DOI 10.3390/pharmaceutics14010010

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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing