Efficacy, Safety, and Pharmacokinetics Study of CJM112 in Hidradenitis Suppurativa Patients



Status:Completed
Conditions:Dermatology, Dermatology
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:Any
Updated:11/24/2017
Start Date:April 13, 2015
End Date:November 23, 2016

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A Randomized, Double-blind, Placebo Controlled, Multiple Dose Study to Evaluate the Clinical Efficacy, Safety, Tolerability, Dose Relation, Pharmacokinetics and Pharmacodynamics of CJM112 in Moderate to Severe Chronic Hidradenitis Suppurativa Patients

This is a randomized, double blind, multicenter study in patients with moderate to severe
chronic hidradenitis suppurativa in parallel groups, to determine the efficacy and safety of
multiple doses of CJM112 in comparison to placebo. The study has two periods to explore
preliminary dose effects.


Inclusion Criteria:

1. Male and female patients 18 to 65 years of age with clinically diagnosed chronic HS
for at least 1 year (prior to screening) who have undergone previous antibiotic
therapy

2. Weight between 50 kg and 150 kg

3. HS-PGA score of at least moderate severity at the time of inclusion with at least 4
abscesses and/or nodules. HS lesions must be present in at least two distinct
anatomical areas, and at least one area must be minimally Hurley Stage II (moderate)

Exclusion Criteria:

1. Use of previous biologics or other specified concomitant medications

2. Use of any systemic treatment for HS in the last 4 weeks prior to randomization

3. Presence of more than 25 draining fistulae.

4. Surgical treatment for HS in the last 4 weeks prior to randomization/first treatment.

5. Women of child-bearing potential and sexually active males unwilling to use a condom
during intercourse while taking drug and for 15 weeks after stopping investigational
medication.

6. Evidence of active tuberculosis at screening

7. History of severe systemic Candida infections or evidence of Candidiasis in the last
two weeks

8. Active systemic or skin infections (other than common cold or HS related) during the
two weeks before randomization/first treatment

9. Any live vaccines (including nasal spray flu vaccine) starting from 6 weeks before
randomization.

Other protocol-defined inclusion/exclusion criteria may apply
We found this trial at
10
sites
Boston, Massachusetts 02118
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Boston, MA
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Atlanta, Georgia 30322
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Atlanta, GA
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Indianapolis, Indiana 46202
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Indianapolis, IN
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Los Angeles, California 90095
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Los Angeles, CA
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Nashville, Tennessee 37205
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Nashville, TN
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Omaha, Nebraska 68144
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Omaha, NE
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Ormond Beach, Florida 32174
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Ormond Beach, FL
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Rockville, Maryland 20852
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Rockville, MD
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Roskilde,
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Tampa, Florida 33613
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Tampa, FL
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