Clinical trial NCT02998671: Study of Efficacy and Safety of CJM112 in Patients With Moderate to Severe Inflammatory Acne
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acne Vulgaris
Keywords: Acne, inflammatory acne, efficacy, safety, PK
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2016-12-20
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study was 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 were to be explored.


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.
* 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:

* 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.
* Use of facial medium depth chemical peels (excluding home regimens) within 3 months prior to baseline.
* Any live vaccines (this includes nasal-spray flu vaccine) starting from 6 weeks before 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.
* History of hypersensitivity or allergy to the investigational compound/compound class being used in this study.
* Active systemic infections (other than common cold) during the 2 weeks prior to baseline.
* History of severe systemic Candida infections or evidence of Candidiasis in the 2 weeks prior to baseline.
* Evidence of active tuberculosis at screening. All patients will be tested for tuberculosis status using a blood test (QuantiFERON®-TB (Tuberculosis) Gold In-Tube). Patients with evidence of tuberculosis may enter the trial afteradequate treatment has been started according to local regulations.
* Patients with known active Crohn's disease
* History of immunodeficiency diseases, including a positive HIV (ELISA and Western blot) test result at screening.
* A positive Hepatitis B surface antigen or Hepatitis C test result at screening
* 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.
* WOCBP, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and for 13 weeks after stopping medication.

Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: Total Inflammatory Facial Lesion Count at Day 85
timeFrame: Day 85
Secondary outcomes:
measure: Number and Severity of Adverse Events in Period 1
timeFrame: Day 1 to Day 85
measure: Number and Severity of Adverse Events in Period 2
timeFrame: Day 86 to Day 260
measure: Pharmacokinetics (PK): Serum Trough Concentrations of CJM112 in Period 1
timeFrame: Day 1, Day 29, Day 57 and Day 85
measure: Pharmacokinetics (PK): Serum Trough Concentrations of CJM112 in Period 2
timeFrame: Day 85, Day 113, Day 141 and Day 169
measure: Number of Patients With Clinically Significant Abnormal Hematology Laboratory Parameters
timeFrame: 38 Weeks
measure: Number of Patients With Clinically Significant Abnormal Clinical Chemistry Laboratory Parameters Parameters
timeFrame: 38 Weeks
measure: Number of Patients With Clinically Significant Abnormal Urinalysis Laboratory Parameters
timeFrame: 38 Weeks
Other outcomes:
Locations:
city: Culver City
country: United States
facility: Novartis Investigative Site
state: California
city: Sacramento
country: United States
facility: Novartis Investigative Site
state: California
city: Austin
country: United States
facility: Novartis Investigative Site
state: Texas
city: Bonn
country: Germany
facility: Novartis Investigative Site
city: Frankfurt
country: Germany
facility: Novartis Investigative Site
city: Muenster
country: Germany
facility: Novartis Investigative Site
city: Pommelsbrunn
country: Germany
facility: Novartis Investigative Site
city: Bergen op Zoom
country: Netherlands
facility: Novartis Investigative Site
city: Groningen
country: Netherlands
facility: Novartis Investigative Site
city: Leiden
country: Netherlands
facility: Novartis Investigative Site
Study officials:
References: