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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02421172
Recruitment Status : Completed
First Posted : April 20, 2015
Last Update Posted : March 15, 2017
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief 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.

Condition or disease Intervention/treatment Phase
Hidradenitis Suppurativa (Acne Inversa) Biological: CJM112 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : April 13, 2015
Actual Primary Completion Date : November 23, 2016
Actual Study Completion Date : November 23, 2016

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Arm 1
CJM112 high dose in period 1; placebo in period 2
Biological: CJM112
Fully human IgG1 monoclonal antibody

Experimental: Arm 2
Placebo in period 1; CJM112 low dose in period 2
Biological: CJM112
Fully human IgG1 monoclonal antibody

Experimental: Arm 3
Placebo in period 1; CJM112 high dose in period 2
Biological: CJM112
Fully human IgG1 monoclonal antibody

Primary Outcome Measures :
  1. Clinical responder rate [ Time Frame: Week 16 ]
    Proportion of study participants achieving a clinical response in Hidradenitis Suppurativa - Physician Global Assessment (HS-PGA) score

Secondary Outcome Measures :
  1. Safety and tolerability as measured by frequency of adverse events [ Time Frame: Week 44 ]
    Frequency of adverse events, in particular infections

  2. Clinical responder rate [ Time Frame: Days 1 to week 44 ]
    Proportion of study participants achieving a clinical response in Hidradenitis Suppurativa - Physician Global Assessment (HS-PGA) score

  3. Pharmacokinetic profile [ Time Frame: Day 1 to Week 44 ]
    Total CJM112 total IL-17A (homodimer) and total IL-17AF (heterodimer) in serum. Cmax (maximum serum concentration following drug administration) Cmax,ss (maximum serum concentration following drug administration at steady state) Cmin,ss Cave,ss Tmax (time to reach the maximum concentration after drug administration) AUCtau (area under the serum concentration-time curve from time zero to the end of the dosing interval tau) AUCtau,ss (area under the serum concentration-time curve from time zero to the end of the dosing interval tau at steady state) CL/F (apparent systemic (or total body) clearance from serum following extravascular administration) T1/2 (terminal elimination half-life) Vz/F (apparent volume of distribution during the terminal elimination phase following extravascular administration)

  4. Immunogenicity [ Time Frame: Day 1 to Week 44 ]
    Anti-CJM112 antibodies in serum

  5. Safety and tolerability as measured by safety laboratories [ Time Frame: Week 44 ]
    Hematology, clinical chemistry and urinalysis

  6. Safety and tolerability as measured by physical exam [ Time Frame: Week 44 ]
    Physical examination

  7. Safety and tolerability as measured by vital signs [ Time Frame: Week 44 ]
    Body temperature, blood pressure, pulse rate

  8. Safety and tolerability as measured by ECG [ Time Frame: Week 44 ]
    PR interval, QRS duration, heart rate, RR, QT, QTc from a standard 12-lead ECG

  9. Pharmacodynamic profile as measured by questionnaires and lesion assements [ Time Frame: Day 1 to Week 44 ]
    Questionnaires to assess the patient reported endpoints such as assessment of efficacy, side effects such as pain, tenderness, quality of life as well as impact on work (Numeric rating scale to assess pain, Brief symptom questionnaire, Patient's global assessment, Patient's treatment satisfaction, Dermatology life quality index, EQ-5D-5L and Work Productivity & Activity Impairment Questionnaire:Specific Health Problem) HS assessment, meausred by HS-Physician's Global assessment. Lesion assessment measured by individual lesion count, new individual lesion count, lesion size, HS clinical response (scoring system based on increase/reduction of number of lesions), Modified Sartorius score (scoring system based on atomical region, type of lesion, distance between lesions) and Hurley score (classification of abscess formation and extent)

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02421172

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United States, California
Novartis Investigative Site
Los Angeles, California, United States, 90045
United States, Florida
Novartis Investigative Site
Ormond Beach, Florida, United States, 32174
Novartis Investigative Site
Tampa, Florida, United States, 33609
United States, Georgia
Novartis Investigative Site
Atlanta, Georgia, United States, 30342
United States, Indiana
Novartis Investigative Site
Indianapolis, Indiana, United States, 46256
United States, Maryland
Novartis Investigative Site
Rockville, Maryland, United States, 20850
United States, Massachusetts
Novartis Investigative Site
Boston, Massachusetts, United States, 02114
United States, Nebraska
Novartis Investigative Site
Omaha, Nebraska, United States, 68144
United States, Tennessee
Novartis Investigative Site
Nashville, Tennessee, United States, 37215
Novartis Investigative Site
Roskilde, Denmark, 4000
Novartis Investigative Site
Berlin, Germany, 10098
Novartis Investigative Site
Bochum, Germany, 44791
Novartis Investigative Site
Groningen, Netherlands
Novartis Investigative Site
Rotterdam, Netherlands, 3015 CE
Novartis Investigative Site
Basel, Switzerland
Novartis Investigative Site
Zurich, Switzerland, CH-8091
Sponsors and Collaborators
Novartis Pharmaceuticals
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Principal Investigator: R Hunger University of Bern, Switzerland
Principal Investigator: Lars French Zurich University Hospital, Switzerland
Principal Investigator: E P Prens Erasmus MC, Rotterdam, Netherlands
Principal Investigator: Gregor Jemec Dermatologisk Afdeling, Roskilde, Denmark
Principal Investigator: Sylke Schneider-Burrus Psoriasis Research and Treatment Center, Charité hospital, Berlin, Germany
Principal Investigator: Christos C Zouboulis Dessau Medical Center, Department of Dermatology, Venerology, Allergology and Immunology, Germany
Principal Investigator: Falk G Bechara Ruhr-University Bochum, Germany
Principal Investigator: Barbara Horváth University Medical Center Groningen, NL
Principal Investigator: Jan Mekkes Dermatologie AMC, Amsterdam, NL
Principal Investigator: Christian Vestergaard Dermato-verenologisk afdeling S, Denmark

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Responsible Party: Novartis Pharmaceuticals Identifier: NCT02421172     History of Changes
Other Study ID Numbers: CCJM112X2202
First Posted: April 20, 2015    Key Record Dates
Last Update Posted: March 15, 2017
Last Verified: March 2017

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Hidradenitis Suppurativa

Additional relevant MeSH terms:
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Hidradenitis Suppurativa
Sweat Gland Diseases
Skin Diseases
Skin Diseases, Bacterial
Bacterial Infections
Skin Diseases, Infectious