Back to resultsEfficacy, Safety, and Pharmacokinetics Study of CJM112 in Hidradenitis Suppurativa Patients
Primary Purpose
Hidradenitis Suppurativa (Acne Inversa)
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
CJM112
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Hidradenitis Suppurativa (Acne Inversa) focused on measuring Hidradenitis Suppurativa
Eligibility Criteria
Inclusion Criteria:
- 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
- Weight between 50 kg and 150 kg
- 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:
- Use of previous biologics or other specified concomitant medications
- Use of any systemic treatment for HS in the last 4 weeks prior to randomization
- Presence of more than 25 draining fistulae.
- Surgical treatment for HS in the last 4 weeks prior to randomization/first treatment.
- 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.
- Evidence of active tuberculosis at screening
- History of severe systemic Candida infections or evidence of Candidiasis in the last two weeks
- Active systemic or skin infections (other than common cold or HS related) during the two weeks before randomization/first treatment
- Any live vaccines (including nasal spray flu vaccine) starting from 6 weeks before randomization.
Other protocol-defined inclusion/exclusion criteria may apply
Sites / Locations
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Placebo Comparator
Placebo Comparator
Experimental
Experimental
Arm Label
Period 1: CJM112 High Dose
Period 1: Placebo
Period 2: CJM112 High Dose (Period 1) / Placebo (Period 2)
Period 2: Placebo (Period 1)/CJM112 Low Dose (Period 2)
Period 2: Placebo (Period 1)/CJM112 High Dose (Period 2)
Arm Description
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
Period 1: Placebo subcutaneously (s.c.) weekly for 5 doses followed by bi-weekly for 5 doses for a total of 10 doses
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
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
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
Outcomes
Primary Outcome Measures
Clinical Responder Rate at Period 1: 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
Clinical Responder Rate Period 1 at 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.
Pharmacokinetics (PK): Ctrough for CJM112 Period 1 and Period 2
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)
Pharmacokinetic Profile: T1/2 The Terminal Elimination Half-life for Period 1 & Period 2/End of Study
T1/2 The terminal elimination half-life for Period 1 (Week 16) and Period 2/End of Study (Week 44)
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
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)
Total Interleukin-17A (IL-17A Homodimer) in Serum at Pre-dose and Post-dose for Period 1 & Period 2
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)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02421172
Brief Title
Efficacy, Safety, and Pharmacokinetics Study of CJM112 in Hidradenitis Suppurativa Patients
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
April 13, 2015 (Actual)
Primary Completion Date
November 23, 2016 (Actual)
Study Completion Date
November 23, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hidradenitis Suppurativa (Acne Inversa)
Keywords
Hidradenitis Suppurativa
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
66 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Period 1: CJM112 High Dose
Arm Type
Experimental
Arm Description
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
Arm Title
Period 1: Placebo
Arm Type
Placebo Comparator
Arm Description
Period 1: Placebo subcutaneously (s.c.) weekly for 5 doses followed by bi-weekly for 5 doses for a total of 10 doses
Arm Title
Period 2: CJM112 High Dose (Period 1) / Placebo (Period 2)
Arm Type
Placebo Comparator
Arm Description
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
Arm Title
Period 2: Placebo (Period 1)/CJM112 Low Dose (Period 2)
Arm Type
Experimental
Arm Description
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
Arm Title
Period 2: Placebo (Period 1)/CJM112 High Dose (Period 2)
Arm Type
Experimental
Arm Description
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
Intervention Type
Biological
Intervention Name(s)
CJM112
Intervention Description
CJM112 Fully human IgG1 monoclonal antibody
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Clinical Responder Rate at Period 1: Week 16
Description
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.
Time Frame
Week 16
Secondary Outcome Measure Information:
Title
Clinical Responder Rate Period 1 at Week 2, 4, 8 and 12
Description
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.
Time Frame
Week 2, 4, 8 and 12
Title
Pharmacokinetics (PK): Ctrough for CJM112 Period 1 and Period 2
Description
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)
Time Frame
Week 16 and Week 44
Title
Pharmacokinetic Profile: T1/2 The Terminal Elimination Half-life for Period 1 & Period 2/End of Study
Description
T1/2 The terminal elimination half-life for Period 1 (Week 16) and Period 2/End of Study (Week 44)
Time Frame
Week 16 (period 1), Week 44 (End of Study Period 2)
Title
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
Description
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)
Time Frame
Week 16 (period 1), Week 44 (End of Study Period 2)
Title
Total Interleukin-17A (IL-17A Homodimer) in Serum at Pre-dose and Post-dose for Period 1 & Period 2
Description
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)
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)
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Weight between 50 kg and 150 kg
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:
Use of previous biologics or other specified concomitant medications
Use of any systemic treatment for HS in the last 4 weeks prior to randomization
Presence of more than 25 draining fistulae.
Surgical treatment for HS in the last 4 weeks prior to randomization/first treatment.
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.
Evidence of active tuberculosis at screening
History of severe systemic Candida infections or evidence of Candidiasis in the last two weeks
Active systemic or skin infections (other than common cold or HS related) during the two weeks before randomization/first treatment
Any live vaccines (including nasal spray flu vaccine) starting from 6 weeks before randomization.
Other protocol-defined inclusion/exclusion criteria may apply
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
R Hunger
Organizational Affiliation
University of Bern, Switzerland
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lars French
Organizational Affiliation
Zurich University Hospital, Switzerland
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
E P Prens
Organizational Affiliation
Erasmus MC, Rotterdam, Netherlands
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gregor Jemec
Organizational Affiliation
Dermatologisk Afdeling, Roskilde, Denmark
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sylke Schneider-Burrus
Organizational Affiliation
Psoriasis Research and Treatment Center, Charité hospital, Berlin, Germany
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Christos C Zouboulis
Organizational Affiliation
Dessau Medical Center, Department of Dermatology, Venerology, Allergology and Immunology, Germany
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Falk G Bechara
Organizational Affiliation
Ruhr-University Bochum, Germany
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Barbara Horváth
Organizational Affiliation
University Medical Center Groningen, NL
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jan Mekkes
Organizational Affiliation
Dermatologie AMC, Amsterdam, NL
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Christian Vestergaard
Organizational Affiliation
Dermato-verenologisk afdeling S, Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
Novartis Investigative Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90045
Country
United States
Facility Name
Novartis Investigative Site
City
Ormond Beach
State/Province
Florida
ZIP/Postal Code
32174
Country
United States
Facility Name
Novartis Investigative Site
City
Tampa
State/Province
Florida
ZIP/Postal Code
33609
Country
United States
Facility Name
Novartis Investigative Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Novartis Investigative Site
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46256
Country
United States
Facility Name
Novartis Investigative Site
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20850
Country
United States
Facility Name
Novartis Investigative Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Novartis Investigative Site
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68144
Country
United States
Facility Name
Novartis Investigative Site
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37215
Country
United States
Facility Name
Novartis Investigative Site
City
Roskilde
ZIP/Postal Code
4000
Country
Denmark
Facility Name
Novartis Investigative Site
City
Berlin
ZIP/Postal Code
10098
Country
Germany
Facility Name
Novartis Investigative Site
City
Bochum
ZIP/Postal Code
44791
Country
Germany
Facility Name
Novartis Investigative Site
City
Groningen
Country
Netherlands
Facility Name
Novartis Investigative Site
City
Rotterdam
ZIP/Postal Code
3015 CE
Country
Netherlands
Facility Name
Novartis Investigative Site
City
Basel
Country
Switzerland
Facility Name
Novartis Investigative Site
City
Zurich
ZIP/Postal Code
CH-8091
Country
Switzerland
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing 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
Learn more about this trial
Efficacy, Safety, and Pharmacokinetics Study of CJM112 in Hidradenitis Suppurativa Patients
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