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

A Randomized, Subject and Investigator Blinded, Placebo Controlled, Multi-center Study in Parallel Groups to Assess the Efficacy and Safety of LYS006 in Patients With Moderate to Severe Inflammatory Acne

ClinicalTrials.gov Identifier: NCT03497897

Novartis Reference Number: CLYS006X2201

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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study 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.

Condition 
Inflammatory Acne
Phase 
Phase 2
Overall status 
Recruiting
Enrollment count 
56 participants
Start date 
Sep 10, 2018
Completion date 
Jul 08, 2021
Gender 
All
Age(s)
18 Years - 45 Years (Adult)

Interventions

Drug
LYS006
Oral administration
Drug
Placebo
Oral administration

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 confirmed by central reading of standardized image capture (Visia® system) by an independent dermatologist at screening and by the investigator's clinical evaluation at 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.

Other protocol-defined inclusion/exclusion criteria may apply.

Study Locations

United States
Novartis Investigative Site
Recruiting
Fremont, 95438
California
United States
Novartis Investigative Site
Recruiting
Santa Monica, 90404
California
United States
Novartis Investigative Site
Recruiting
Hialeah, 33016
Florida
United States
Novartis Investigative Site
Withdrawn
Louisville, 40291
Kentucky
United States
Novartis Investigative Site
Completed
New Orleans, 70115
Louisiana
United States
Novartis Investigative Site
Recruiting
Detroit, 48202
Michigan
United States
Novartis Investigative Site
Withdrawn
Hershey, 17033
Pennsylvania
United States
Novartis Investigative Site
Recruiting
Johnston, 02919
Rhode Island
United States
Novartis Investigative Site
Recruiting
Charleston, 29407
South Carolina
United States
Novartis Investigative Site
Recruiting
Houston, 77030
Texas
United States
Novartis Investigative Site
Recruiting
Pflugerville, 78660
Texas
United States
Czechia
Novartis Investigative Site
Recruiting
Prague, 11000
Prague 1
Czechia
Novartis Investigative Site
Recruiting
Plzen, 305 99
-
Czechia
Germany
Novartis Investigative Site
Recruiting
Bad Bentheim, 48455
-
Germany
Novartis Investigative Site
Recruiting
Berlin, 13353
-
Germany
Novartis Investigative Site
Recruiting
Bonn, 53111
-
Germany
Novartis Investigative Site
Recruiting
Frankfurt, 60590
-
Germany
Novartis Investigative Site
Recruiting
Hamburg, 22143
-
Germany
Novartis Investigative Site
Recruiting
Mainz, 55131
-
Germany
Novartis Investigative Site
Withdrawn
Pommelsbrunn, 91224
-
Germany
Hungary
Novartis Investigative Site
Recruiting
Budapest, 1085
-
Hungary
Novartis Investigative Site
Recruiting
Szeged, 6725
-
Hungary
Netherlands
Novartis Investigative Site
Withdrawn
Leiden, 2333 CL
-
Netherlands
Novartis Investigative Site
Recruiting
Nijmegen, 6525EX
-
Netherlands

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 
1-888-669-6682
Name: 
Novartis Pharmaceuticals
Phone: 
+41613241111
Email: 

Have a question?

Call 1-999-669-6682 or email [email protected]