acne
Conditions
Interventions
Sponsors
Novartis
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: -Male and female subjects aged 18 to 45 years of age included. -Body weight between 50 and 120 kg, inclusive, at screening. -Patients 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.
Exclusion criteria
Exclusion criteria: - 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. - 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 the duration of the study for treatment period 1). - Use of any oral/systemic treatment for acne, including oral antibiotics, dapsone, oral zinc within 4 weeks prior to baseline. -Use of systemic or lesional injected (for acne) corticosteroids or systemic immunomodulators (such as cyclosporine, methotrexate, azathioprine, etc.) within 4 weeks before baseline -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. -Previous treatment with biologics (such as anti-TNF* 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. - Any previous treatment with IL-17 or IL17R blocking agents, including, but not limited to secukinumab, ixekizumab, bimekizumab or brodalumab. -Use of oral retinoids (in particular isotretinoin) within the last 6 months prior to baseline. -Use of facial medium depth chemical peels (excluding home regimens) within 3 months prior to baseline. -Patients with known active Crohn*s disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the efficacy of CJM112 versus placebo on facial inflammatory lesion counts in patients with moderate to severe inflammatory acne | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the safety and tolerability of CJM112 in patients with moderate to severe inflammatory acne. To assess the pharmacokinetics of CJM112 in patients with moderate to severe acne | — |
Countries
Germany, Netherlands, United States of America
Outcome results
None listed