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



Status:Terminated
Conditions:Acne, Acne, Dermatology
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:18 - 45
Updated:11/8/2018
Start Date:December 22, 2016
End Date:August 1, 2018

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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

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.


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.
We found this trial at
6
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Berlin,
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Austin, Texas 78759
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Austin, TX
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Culver City, California 90230
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Culver City, CA
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Hershey, Pennsylvania 17033
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Hershey, PA
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High Point, North Carolina 27262
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High Point, NC
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Sacramento, California 95825
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Sacramento, CA
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