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Trial record 19 of 90 for:    hidradenitis suppurativa

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

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ClinicalTrials.gov Identifier: NCT02421172
Recruitment Status : Completed
First Posted : April 20, 2015
Results First Posted : May 23, 2019
Last Update Posted : May 23, 2019
Sponsor:
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 Drug: Placebo 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: 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
Biological: CJM112
CJM112 Fully human IgG1 monoclonal antibody

Placebo Comparator: 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
Drug: Placebo
Placebo Comparator: 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
Drug: Placebo
Experimental: 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
Biological: CJM112
CJM112 Fully human IgG1 monoclonal antibody

Experimental: 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
Biological: CJM112
CJM112 Fully human IgG1 monoclonal antibody




Primary Outcome Measures :
  1. Clinical Responder Rate at Period 1: Week 16 [ Time Frame: Week 16 ]
    Proportion of study participants achieving a clinical response in Hidradenitis Suppurativa - Physician Global Assessment (HS-PGA) score An HS-PGA responder in period 1 was a participant who had an initial HS-PGA score of at least 3 at baseline (Day 1, inclusion criterion) that decreased by at least 2 points. The six-point Physician Global Assessment (PGA) (scores range from 0-5) based on the number of HS lesions ranges from clear to very severe.


Secondary Outcome Measures :
  1. Clinical Responder Rate Period 1 at Week 2, 4, 8 and 12 [ Time Frame: Week 2, 4, 8 and 12 ]
    Proportion of study participants achieving a clinical response in Hidradenitis Suppurativa - Physician Global Assessment (HS-PGA) score A HS-PGA responder in Period 1 is a study participant who had an initial HS-PGA score of at least 3 at Baseline (Day 1, inclusion criterion) that decreased by at least 2 points. The six-point Physician Global Assessment (PGA) (scores range from 0-5) based on the number of HS lesions ranges from clear to very severe.

  2. Pharmacokinetics (PK): Ctrough for CJM112 Period 1 and Period 2 [ Time Frame: Week 16 and Week 44 ]
    Ctrough is the serum concentration that is just prior to the beginning of, or at the end, of a dosing interval (mass/volume) for Period 1 (week 16) and Period 2/End of Study (week 44)

  3. Pharmacokinetic Profile: T1/2 The Terminal Elimination Half-life for Period 1 & Period 2/End of Study [ Time Frame: Week 16 (period 1), Week 44 (End of Study Period 2) ]
    T1/2 The terminal elimination half-life for Period 1 (Week 16) and Period 2/End of Study (Week 44)

  4. Immunogenicity - Incidence of ADA-positive and ADA-negative in Participants With or Without Pre-existing Antibodies in Period 1 and Period 2/End of Study [ Time Frame: Week 16 (period 1), Week 44 (End of Study Period 2) ]
    Immunogenicity - Incidence of semi-quantitative determination of anti-CJM112 antibodies or ADAs. ADA-positive and ADA-negative in participants with or without pre-existing antibodies Period 1 (week 16) and Period 2/End of Study (week 44)

  5. Total Interleukin-17A (IL-17A Homodimer) in Serum at Pre-dose and Post-dose for Period 1 & Period 2 [ Time Frame: Pre-dose (Period 1 Day 1 & Period 2 Day 113), Post-dose Period 1(Day 99) and post-dose Period 2 (Day 211) ]
    Total Interleukin-17A (IL-17A homodimer) in serum at Pre-dose Period 1 (Day 1) & Pre-dose Period 2 (Day 113) and Post-dose Period 1 (Day 99) and Post-dose Period 2 (Day 211)



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
Criteria

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 ClinicalTrials.gov identifier (NCT number): NCT02421172


Locations
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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
Denmark
Novartis Investigative Site
Roskilde, Denmark, 4000
Germany
Novartis Investigative Site
Berlin, Germany, 10098
Novartis Investigative Site
Bochum, Germany, 44791
Netherlands
Novartis Investigative Site
Groningen, Netherlands
Novartis Investigative Site
Rotterdam, Netherlands, 3015 CE
Switzerland
Novartis Investigative Site
Basel, Switzerland
Novartis Investigative Site
Zurich, Switzerland, CH-8091
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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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
ClinicalTrials.gov Identifier: NCT02421172     History of Changes
Other Study ID Numbers: CCJM112X2202
First Posted: April 20, 2015    Key Record Dates
Results First Posted: May 23, 2019
Last Update Posted: May 23, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description:

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com


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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Hidradenitis Suppurativa
Additional relevant MeSH terms:
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Hidradenitis Suppurativa
Hidradenitis
Sweat Gland Diseases
Skin Diseases
Skin Diseases, Bacterial
Bacterial Infections
Skin Diseases, Infectious
Infection
Suppuration