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

• ClinicalTrials.gov Identifier: NCT02421172
• Recruitment Status: Completed
• First Posted: April 20, 2015
• Results First Posted: May 23, 2019
• Last Update Posted: July 13, 2022
• Sponsor: Novartis Pharmaceuticals
• Information provided by (Responsible Party): Novartis ( Novartis Pharmaceuticals )

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.

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

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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)

Eligibility Criteria

• 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

Contacts and Locations

Locations

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

• 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

More Information

• Responsible Party: Novartis Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT02421172
• Other Study ID Numbers: CCJM112X2202
• First Posted: April 20, 2015
• Results First Posted: May 23, 2019
• Last Update Posted: July 13, 2022
• Last Verified: June 2022

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

• 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:

Hidradenitis Suppurativa; Hidradenitis; Sweat Gland Diseases; Skin Diseases; Skin Diseases, Bacterial; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Suppuration