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

NCT ID: NCT03497897

Last Updated: 2023-08-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-10
• Study Completion Date: 2022-03-09

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.

Conditions

Inflammatory Acne

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

LYS006 20 mg BID

LYS006, 20 mg, orally, twice daily (BID), for 12 weeks

Group Type: EXPERIMENTAL

LYS006 20 mg

Intervention Type: DRUG

LYS006 20 mg, capsules, oral administration, BID, for 12 weeks

LYS006 2 mg BID

LYS006, 2 mg, orally, BID, for 12 weeks

Group Type: EXPERIMENTAL

LYS006 2 mg

Intervention Type: DRUG

LYS006 2 mg, capsules, oral administration, BID, for 12 weeks

Placebo BID

Matching placebo, orally, BID, for 12 weeks

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Matching placebo, capsules, oral administration, BID, for 12 weeks

Interventions

LYS006 20 mg

LYS006 20 mg, capsules, oral administration, BID, for 12 weeks

Intervention Type: DRUG

LYS006 2 mg

LYS006 2 mg, capsules, oral administration, BID, for 12 weeks

Intervention Type: DRUG

Placebo

Matching placebo, capsules, oral administration, BID, for 12 weeks

Intervention Type: DRUG

Eligibility Criteria

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.
• Patients with papulo-pustular acne vulgaris (inflammatory acne) presenting with 20 to 100 facial inflammatory lesions (papules, pustules and nodules) at baseline, no more than 2 facial inflammatory nodules or cysts at screening and baseline, and a minimun number of 10 non-inflammatory facial lesions (open and closed comedones).
• Patients who are candidates for systemic treatment and for whom in the opinion of the investigator, an appropriate previous treatment with topical anti-acne medication failed, or was not well tolerated, or is not indicated (e.g., due to large body surface area affected, e.g., on the back)
• Patients with Grade 3 (moderate) or Grade 4 (severe) IGA score assessed by the investigator at screening and baseline.

Exclusion Criteria

• Appropriate wash out periods are required for investigational drugs, any oral/systemic treatment for acne, systemic or lesional injected (for acne) corticosteroids or systemic immunomodulators, any systemic hormonal treatments, previous treatment with biologics, oral retinoids (in particular isotretinoin) and any topical anti-acne treatment.
• Previous surgical, physical (such as ThermaClear™), light (including blue or UV light, photodynamic therapy or laser therapy within 4 weeks prior to baseline
• Use of facial medium depth chemical peels (excluding home regimens) within 3 months prior to baseline.
• Any other forms of acne
• Any severe, progressive or uncontrolled medical or psychiatric condition or other factors at randomization that in the judgment of the investigator prevents the patient from participating in the study.
• Active systemic infections (other than common cold) during the 2 weeks prior to baseline.
• History of immunodeficiency diseases, including a positive HIV (ELISA and Western blot) test result at screening.
• Chronic infection with Hepatitis B or Hepatitis C virus.
• Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive Human chorionic gonadotropin (HCG) laboratory test.
• Sexually active males or women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using basic methods of contraception during dosing of study treatment.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Novartis Investigative Site

Fremont, California, United States

Novartis Investigative Site

Santa Monica, California, United States

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

Novartis Investigative Site

Bad Bentheim, , Germany

Novartis Investigative Site

Berlin, , Germany

Novartis Investigative Site

Bonn, , Germany

Novartis Investigative Site

Frankfurt, , Germany

Novartis Investigative Site

Budapest, , Hungary

Novartis Investigative Site

Szeged, , Hungary

Novartis Investigative Site

Nijmegen, , Netherlands

Countries

United States; Czechia; France; Germany; Hungary; Netherlands

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

http://www.novctrd.com/ctrdweb/patientsummary/patientsummaries?patientSummaryId=1441

A Plain Language Trial Summary is available on novctrd.com

Other Identifiers

2017-003191-30

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CLYS006X2201

Identifier Type: -

Identifier Source: org_study_id