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

NCT02421172 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2022-07-13

Study results available
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Summary

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.

Conditions

  • Hidradenitis Suppurativa (Acne Inversa)

Interventions

BIOLOGICAL

CJM112

CJM112 Fully human IgG1 monoclonal antibody

DRUG

Placebo

Sponsors & Collaborators

Principal Investigators

  • R Hunger · University of Bern, Switzerland

  • Lars French · Zurich University Hospital, Switzerland

  • E P Prens · Erasmus MC, Rotterdam, Netherlands

  • Gregor Jemec · Dermatologisk Afdeling, Roskilde, Denmark

  • Sylke Schneider-Burrus · Psoriasis Research and Treatment Center, Charité hospital, Berlin, Germany

  • Christos C Zouboulis · Dessau Medical Center, Department of Dermatology, Venerology, Allergology and Immunology, Germany

  • Falk G Bechara · Ruhr-University Bochum, Germany

  • Barbara Horváth · University Medical Center Groningen, NL

  • Jan Mekkes · Dermatologie AMC, Amsterdam, NL

  • Christian Vestergaard · Dermato-verenologisk afdeling S, Denmark

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-04-13
Primary Completion
2016-11-23
Completion
2016-11-23
FDA Drug
Yes

Countries

  • United States
  • Denmark
  • Germany
  • Netherlands
  • Switzerland

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02421172 on ClinicalTrials.gov