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

Phase 2

Completed

• Conditions: Inflammatory Acne
• Interventions: Drug: LYS006 2 mg; Drug: Placebo; Drug: LYS006 20 mg

• Registration Number: NCT03497897
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

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.

Detailed Description

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 Timeline

• Study First Submitted: 2018-04-06
• Study First Submitted QC: 2018-04-06
• Study First Posted: 2018-04-13
• Study Start: 2018-09-10
• Primary Completion: 2022-02-24
• Study Completion: 2022-03-09
• Results First Submitted: 2023-02-21
• Results First Submitted QC: 2023-02-21
• Results First Posted: 2023-03-20
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-29
• Last Update Posted: 2023-08-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LYS006 2 mg BID	LYS006 2 mg	LYS006, 2 mg, orally, BID, for 12 weeks
Placebo BID	Placebo	Matching placebo, orally, BID, for 12 weeks
LYS006 20 mg BID	LYS006 20 mg	LYS006, 20 mg, orally, twice daily (BID), for 12 weeks

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Novartis Investigative Site; 🇳🇱 Nijmegen, Netherlands