A randomized, subject and investigator blinded, placebo controlled, multi-center study in parallel groups to assess the efficacy and safety of CJM112 in patients with moderate to severe inflammatory acne

ovartis Pharma AG0 sites75 target enrollmentSeptember 22, 2016

ConditionsModerate to Severe Inflammatory Acne MedDRA version: 19.1Level: LLTClassification code 10000519Term: Acne vulgarisSystem Organ Class: 100000004858 Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Moderate to Severe Inflammatory Acne
Sponsor: ovartis Pharma AG
Enrollment: 75
Status: Active, not recruiting
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

September 22, 2016

End Date

TBD

Last Updated

7 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

ovartis Pharma AG

Eligibility Criteria

Inclusion Criteria

•\-Male and female subjects aged 18 to 45 years of age included, 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, inclusive at screening.
•\-Patient with papulo\-pustular acne vulgaris with between 25 and 100 facial inflammatory lesions (papules, pustules and nodules), and presence of non\-inflammatory lesions (open and closed comedones) in the face at screening and baseline, who have failed systemic therapy for inflammatory acne.
•\-No more than 5 facial inflammatory nodules at screening and baseline.
•\-Investigator's Global assessment (IGA) score of at least moderate (3\) acne severity on the face at screening and baseline.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1\.2 Adults (18\-64 years) yes
•F.1\.2\.1 Number of subjects for this age range 75
•F.1\.3 Elderly (\>\=65 years) no

Exclusion Criteria

•1\.Use of investigational drugs at the time of screening, or within 4 weeks or 5 half\-lives of baseline, whichever is longer; or longer if required by local regulations.
•2\.Use of any topical anti\-acne prescription treatment within 2 weeks and any over the counter (OTC) anti\-acne treatment within 1 week of baseline (use of medicated (anti\-acne) creams, medicated cleansers or medicated soaps is prohibited for Treatment Period 1\).
•3\.Use of any oral/systemic treatment for acne, including oral antibiotics, dapsone, oral zinc within 4 weeks prior to baseline.
•4\.Use of systemic or lesional injected (for acne) corticosteroids or systemic immunomodulators (such as cyclosporine, methotrexate, azathioprine, etc.) within 4 weeks before baseline
•5\.Use of any systemic hormonal treatment (in particular anti\-androgens, such as spironolactone, finasteride and cyproterone acetate) within 1 month before baseline. Oral contraceptives can be continued if stable for the last 3 months before baseline and if stable in dose and dosing regimen and type (brand) and if the patient plans to continue throughout the study period.
•6\.Previous treatment with biologics (such as anti\-TNFa agents or anti\-IL\-1\) within 3 months prior to baseline; Anti\-IL\-12/23 blocking agents (such as briakinumab and ustekinumab or p19 antibodies) within 6 months prior to baseline.
•7\.Any previous treatment with IL\-17 or IL17R blocking agents, including, but not limited to secukinumab, ixekizumab, bimekizumab or brodalumab.
•8\.Use of oral retinoids (in particular isotretinoin) within the last 6 months prior to baseline.
•9\.Use of facial medium depth chemical peels (excluding home regimens) within 3 months prior to baseline.
•10\.Any live vaccines (this includes nasal\-spray flu vaccine) starting from 6 weeks before baseline.