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

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

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.

Study Overview

• Status: Completed
• Conditions: Hidradenitis Suppurativa (Acne Inversa)
• Intervention / Treatment: Drug: Placebo; Biological: CJM112

• Study Type: Interventional
• Enrollment (Actual): 66
• Phase: Phase 2

Contacts and Locations

Study Locations

• Denmark
  • Roskilde, Denmark, 4000
    • Novartis Investigative Site
• Germany
  • Berlin, Germany, 10098
    • Novartis Investigative Site
  • Bochum, Germany, 44791
    • Novartis Investigative Site
• Netherlands
  • Groningen, Netherlands
    • Novartis Investigative Site
  • Rotterdam, Netherlands, 3015 CE
    • Novartis Investigative Site
• Switzerland
  • Basel, Switzerland
    • Novartis Investigative Site
  • Zurich, Switzerland, CH-8091
    • Novartis Investigative Site
• United States
  • California
    • Los Angeles, California, United States, 90045
      • Novartis Investigative Site
  • Florida
    • Ormond Beach, Florida, United States, 32174
      • Novartis Investigative Site
    • Tampa, Florida, United States, 33609
      • Novartis Investigative Site
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • Novartis Investigative Site
  • Indiana
    • Indianapolis, Indiana, United States, 46256
      • Novartis Investigative Site
  • Maryland
    • Rockville, Maryland, United States, 20850
      • Novartis Investigative Site
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Novartis Investigative Site
  • Nebraska
    • Omaha, Nebraska, United States, 68144
      • Novartis Investigative Site
  • Tennessee
    • Nashville, Tennessee, United States, 37215
      • Novartis Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

5

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Week 16

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Week 2, 4, 8 and 12
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)	Week 16 and 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)	Week 16 (period 1), Week 44 (End of Study Period 2)
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)	Week 16 (period 1), Week 44 (End of Study Period 2)
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)	Pre-dose (Period 1 Day 1 & Period 2 Day 113), Post-dose Period 1(Day 99) and post-dose Period 2 (Day 211)

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals
• Investigators: 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

Study record dates

Study Major Dates

• Study Start (Actual): April 13, 2015
• Primary Completion (Actual): November 23, 2016
• Study Completion (Actual): November 23, 2016

Study Registration Dates

• First Submitted: March 18, 2015
• First Submitted That Met QC Criteria: April 15, 2015
• First Posted (Estimate): April 20, 2015

Study Record Updates

• Last Update Posted (Actual): July 13, 2022
• Last Update Submitted That Met QC Criteria: June 17, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: Hidradenitis Suppurativa
• Additional Relevant MeSH Terms: Sweat Gland Diseases; Skin Diseases; Infections; Bacterial Infections; Bacterial Infections and Mycoses; Skin Diseases, Infectious; Suppuration; Skin Diseases, Bacterial; Hidradenitis Suppurativa; Hidradenitis
• Other Study ID Numbers: CCJM112X2202

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

IPD 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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No