Efficacy, Safety, and Pharmacokinetics Study of CJM112 in Hidradenitis Suppurativa Patients
NCT ID: NCT02421172
Last Updated: 2022-07-13
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
66 participants
INTERVENTIONAL
2015-04-13
2016-11-23
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Period 1: CJM112 High Dose
Period 1: CJM112 High Dose subcutaneously (s.c.) weekly for 5 doses followed by bi-weekly for 5 doses for a total of 10 doses
CJM112
CJM112 Fully human IgG1 monoclonal antibody
Period 1: Placebo
Period 1: Placebo subcutaneously (s.c.) weekly for 5 doses followed by bi-weekly for 5 doses for a total of 10 doses
Placebo
Period 2: CJM112 High Dose (Period 1) / Placebo (Period 2)
Period 2: Placebo subcutaneously (s.c.) weekly for 5 doses then bi-weekly for 5 doses for a total of 10 doses this group.This group was on CJM112 High Dose in Period 1
Placebo
Period 2: Placebo (Period 1)/CJM112 Low Dose (Period 2)
Period 2: CJM112 Low Dose subcutaneously (s.c.) weekly for 5 doses then bi-weekly for 5 doses for a total of 10 doses this group.This group was on Placebo in Period 1
CJM112
CJM112 Fully human IgG1 monoclonal antibody
Period 2: Placebo (Period 1)/CJM112 High Dose (Period 2)
Period 2: CJM112 High Dose subcutaneously (s.c.) weekly for 5 doses then bi-weekly for 5 doses for a total of 10 doses this group.This group was on Placebo in Period 1
CJM112
CJM112 Fully human IgG1 monoclonal antibody
Interventions
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CJM112
CJM112 Fully human IgG1 monoclonal antibody
Placebo
Eligibility Criteria
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Inclusion Criteria
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
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.
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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R Hunger
Role: PRINCIPAL_INVESTIGATOR
University of Bern, Switzerland
Lars French
Role: PRINCIPAL_INVESTIGATOR
Zurich University Hospital, Switzerland
E P Prens
Role: PRINCIPAL_INVESTIGATOR
Erasmus MC, Rotterdam, Netherlands
Gregor Jemec
Role: PRINCIPAL_INVESTIGATOR
Dermatologisk Afdeling, Roskilde, Denmark
Sylke Schneider-Burrus
Role: PRINCIPAL_INVESTIGATOR
Psoriasis Research and Treatment Center, Charité hospital, Berlin, Germany
Christos C Zouboulis
Role: PRINCIPAL_INVESTIGATOR
Dessau Medical Center, Department of Dermatology, Venerology, Allergology and Immunology, Germany
Falk G Bechara
Role: PRINCIPAL_INVESTIGATOR
Ruhr-University Bochum, Germany
Barbara Horváth
Role: PRINCIPAL_INVESTIGATOR
University Medical Center Groningen, NL
Jan Mekkes
Role: PRINCIPAL_INVESTIGATOR
Dermatologie AMC, Amsterdam, NL
Christian Vestergaard
Role: PRINCIPAL_INVESTIGATOR
Dermato-verenologisk afdeling S, Denmark
Locations
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Novartis Investigative Site
Los Angeles, California, United States
Novartis Investigative Site
Ormond Beach, Florida, United States
Novartis Investigative Site
Tampa, Florida, United States
Novartis Investigative Site
Atlanta, Georgia, United States
Novartis Investigative Site
Indianapolis, Indiana, United States
Novartis Investigative Site
Rockville, Maryland, United States
Novartis Investigative Site
Boston, Massachusetts, United States
Novartis Investigative Site
Omaha, Nebraska, United States
Novartis Investigative Site
Nashville, Tennessee, United States
Novartis Investigative Site
Roskilde, , Denmark
Novartis Investigative Site
Berlin, , Germany
Novartis Investigative Site
Bochum, , Germany
Novartis Investigative Site
Groningen, , Netherlands
Novartis Investigative Site
Rotterdam, , Netherlands
Novartis Investigative Site
Basel, , Switzerland
Novartis Investigative Site
Zurich, , Switzerland
Countries
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Other Identifiers
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CCJM112X2202
Identifier Type: -
Identifier Source: org_study_id
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