Study of Efficacy and Safety of CJM112 in Patients With Moderate to Severe Inflammatory Acne

Study Overview
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Brief Summary
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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.

Official Title
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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
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Acne Vulgaris

Intervention / Treatment
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* Biological: CJM112
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1: CJM112 high dose<br>CJM112 high dose in treatment period 1; CJM112 high dose in extension period 2 | Biological: CJM112<br> <br> |
| Experimental: Group 2: CJM112 low dose<br>CJM112 low dose in treatment period 1; CJM112 low dose in extension period 2 | Biological: CJM112<br> <br> |
| Placebo Comparator: Group 3: Placebo, CJM112 low dose or high dose<br>Placebo in treatment period 1; CJM112 low dose or CJM112 high dose in extension period 2 | Biological: CJM112<br> <br> Other: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Inflammatory Facial Lesion Count at Day 85 | Total inflammatory facial lesion count was the total count of papules, pustules and nodules assessed at day 85 | Day 85 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number and Severity of Adverse Events in Period 1 | Frequency and severity of adverse events in Period 1 | Day 1 to Day 85 | 
| Number and Severity of Adverse Events in Period 2 | Frequency and severity of adverse events in Period 2 | Day 86 to Day 260 | 
| Pharmacokinetics (PK): Serum Trough Concentrations of CJM112 in Period 1 | Pharmacokinetics (PK): Serum trough concentrations of CJM112. Concentrations below the lower limit of quantification were reported as 0. | Day 1, Day 29, Day 57 and Day 85 | 
| Pharmacokinetics (PK): Serum Trough Concentrations of CJM112 in Period 2 | Pharmacokinetics (PK): Serum trough concentrations of CJM112. Concentrations below the lower limit of quantification were reported as 0. | Day 85, Day 113, Day 141 and Day 169 | 
| Number of Patients With Clinically Significant Abnormal Hematology Laboratory Parameters | Abnormalities were considered clinically significant by the Investigator if they could impact the study conduct or safety of the subjects. | 38 Weeks | 
| Number of Patients With Clinically Significant Abnormal Clinical Chemistry Laboratory Parameters Parameters | Abnormalities were considered clinically significant by the Investigator if they could impact the study conduct or safety of the subjects. | 38 Weeks | 
| Number of Patients With Clinically Significant Abnormal Urinalysis Laboratory Parameters | Abnormalities were considered clinically significant by the Investigator if they could impact the study conduct or safety of the subjects. | 38 Weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acne, inflammatory acne, efficacy, safety, PK