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.
This was a randomized, placebo-controlled, subject- and investigator-blinded, multicenter, nonconfirmatory, parallel group, and proof-of-concept study in adult patients with moderate to severe inflammatory acne. After an initial screening period (up to 4 weeks), subjects were treated with LYS006 or matching placebo for 12 consecutive weeks to assess preliminary clinical efficacy, safety, and tolerability in the targeted subject population. At the beginning of the treatment period, subjects were randomized to one of three treatment groups, i.e., LYS006 20 mg twice daily (BID), LYS006 2 mg BID or matching placebo in a 3:1:3 ratio. After treatment period completion, all subjects entered a post-treatment safety follow-up period of 4 weeks without study drug administration. The maximum duration of study participation was 20 weeks. Study completion was defined as when the last subject completed his/her study completion visit, and any repeat assessments associated with this visit were documented and followed-up appropriately by the investigator, or in the event of an early study termination decision, the date of that decision.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
66
LYS006 20 mg, capsules, oral administration, BID, for 12 weeks
LYS006 2 mg, capsules, oral administration, BID, for 12 weeks
Matching placebo, capsules, oral administration, BID, for 12 weeks
Novartis Investigative Site
Fremont, California, United States
Novartis Investigative Site
Santa Monica, California, United States
Total Inflammatory Lesion Count
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.
Time frame: Week 12
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Novartis Investigative Site
Hialeah, Florida, United States
Novartis Investigative Site
New Orleans, Louisiana, United States
Novartis Investigative Site
Detroit, Michigan, United States
Novartis Investigative Site
Houston, Texas, United States
Novartis Investigative Site
Pflugerville, Texas, United States
Novartis Investigative Site
Pilsen, Czechia
Novartis Investigative Site
Nice, France
Novartis Investigative Site
Nice, France
...and 7 more locations