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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03497897
Recruitment Status : Completed
First Posted : April 13, 2018
Last Update Posted : November 24, 2022
Information provided by (Responsible Party):
Novartis ( 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.

Condition or disease Intervention/treatment Phase
Inflammatory Acne Drug: LYS006 Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 67 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : September 10, 2018
Actual Primary Completion Date : February 24, 2022
Actual Study Completion Date : March 9, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne Safety

Arm Intervention/treatment
Experimental: LYS006 high dose Drug: LYS006
Oral administration

Experimental: LYS006 low dose Drug: LYS006
Oral administration

Placebo Comparator: Placebo Drug: Placebo
Oral administration

Primary Outcome Measures :
  1. Total inflammatory lesion count [ Time Frame: Week 12 ]
    Inflammatory facial lesion count (papules, pustules, nodules)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03497897

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United States, California
Novartis Investigative Site
Fremont, California, United States, 95438
Novartis Investigative Site
Santa Monica, California, United States, 90404
United States, Florida
Novartis Investigative Site
Hialeah, Florida, United States, 33016
United States, Louisiana
Novartis Investigative Site
New Orleans, Louisiana, United States, 70115
United States, Michigan
Novartis Investigative Site
Detroit, Michigan, United States, 48202
United States, Texas
Novartis Investigative Site
Houston, Texas, United States, 77030
Novartis Investigative Site
Pflugerville, Texas, United States, 78660
Novartis Investigative Site
Plzen, Czechia, 305 99
Novartis Investigative Site
Nice Cedex, France, 06202
Novartis Investigative Site
Nice, France, 06000
Novartis Investigative Site
Bad Bentheim, Germany, 48455
Novartis Investigative Site
Berlin, Germany, 13353
Novartis Investigative Site
Bonn, Germany, 53111
Novartis Investigative Site
Frankfurt, Germany, 60590
Novartis Investigative Site
Budapest, Hungary, 1085
Novartis Investigative Site
Szeged, Hungary, 6725
Novartis Investigative Site
Nijmegen, Netherlands, 6525EX
Sponsors and Collaborators
Novartis Pharmaceuticals
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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03497897    
Other Study ID Numbers: CLYS006X2201
First Posted: April 13, 2018    Key Record Dates
Last Update Posted: November 24, 2022
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description:

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Acne, efficacy, safety
Additional relevant MeSH terms:
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Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases