The study is designed primarily to assess preliminary efficacy and safety of CJM112 in patients with moderate to severe inflammatory acne and to determine if CJM112 has an adequate clinical profile for further clinical development. In addition,…
ID
Source
Brief title
Condition
- Epidermal and dermal conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To assess the efficacy of CJM112 versus placebo on facial inflammatory lesion
counts in patients with moderate to severe inflammatory acne
Secondary outcome
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
Background summary
Moderate to severe inflammatory acne is a debilitating disease, with visible
inflammatory lesions on the face and subsequent risk of permanent scars. The
current treatment is often a combination or association of several topical
treatments (such as topical retinoids and
antibacterials such as benzoylperoxide and antibiotics) with oral antibiotics,
and/or hormonal treatment or retinoids, such as isotretinoin. It is more and
more recognized that inflammatory acne is not an infectious disease, but rather
an inflammatory skin disease, in which Propionibacterium acnes (P. acnes) and
innate immunity play critical roles. Recently the role of IL-17A in early acne
lesions has been demonstrated by upregulated IL-17A in lesional versus
non-lesional acne skin, both at RNA as well as at protein level. Serum IL17A is
increased in acne patients and reduced by effective treatment after 12 weeks
(Karadag et al 2012).
CJM112 is an affinity matured fully human monoclonal antibody (mAb) that
demonstrates high affinity to IL-17A and IL-17AF
Study objective
The study is designed primarily to assess preliminary efficacy and safety of
CJM112 in patients with moderate to severe inflammatory acne and to determine
if CJM112 has an adequate clinical profile for further clinical development. In
addition, sustainability of response and dose relationship will be explored.
Study design
This is a randomized, subject and investigator blinded, placebo controlled,
multi-center study in parallel groups.
Subject receives:
Period 1 (8 weeks): CJM112 high dose (300 mg) monthly
Period 2 (12 weeks): CJM112 high dose (300 mg) monthly
Treatment arm 2:
Period 1 (8 weeks): CJM112 low dose (75 mg) monthly
Period 2 (12 weeks): CJM112 low dose (75 mg) monthly
Treatment arm 3:
Period 1 (8 weeks): Placebo monthly
Period 2 (12 weeks): CJM112 high dose (300 mg) or CJM112 low dose (75 mg)
monthly
Intervention
CJM112 or placebo.
Study burden and risks
Studyperiod: 11 months, 10 visits, varying from 2-4 hours per visit
Physical examination: 7 times
Bloodpressure, pulse and bodytemerature:10 times
Blood and urine collection: 10 times
ECG: 6 times
Imaging: 5 times
Measuring sebum face skin(sebumeter): 4 times
Completion of 3 questionnaires: 4 times
For CHDR only: During treatment and follow-up period: Daily selfie via special
app.
Optional:
Blood collection for pharmacogenetic examination
Skin biopt (optional): 3 times
Forbidden co-medication.
Raapopseweg 1
Arnhem 6824 DP
NL
Raapopseweg 1
Arnhem 6824 DP
NL
Listed location countries
Age
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
- 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
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2016-002492-95-NL |
| ClinicalTrials.gov | NCT02998671 |
| CCMO | NL58510.056.16 |