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
- Conditions
- acne10014982
- Registration Number
- NL-OMON47130
- Lead Sponsor
- ovartis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 30
-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.
- 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>To assess the efficacy of CJM112 versus placebo on facial inflammatory lesion<br /><br>counts in patients with moderate to severe inflammatory acne</p><br>
- Secondary Outcome Measures
Name Time Method <p>To assess the safety and tolerability of CJM112 in patients with moderate to<br /><br>severe inflammatory acne.<br /><br>To assess the pharmacokinetics of CJM112 in patients with moderate to severe<br /><br>acne</p><br>