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

NCT02421172 | Completed Phase 2 Results FDA Drug

• 1 other identifier: CCJM112X2202
• Study Type: interventional
• Target: 66
• Locations: 5 countries
• Sites: 16

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.

Conditions

Hidradenitis Suppurativa (Acne Inversa)

Keywords

Hidradenitis Suppurativa

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Clinical Responder Rate Period 1 at Week 2, 4, 8 and 12

  Week 2, 4, 8 and 12

• Pharmacokinetics (PK): Ctrough for CJM112 Period 1 and Period 2

  Week 16 and Week 44

• Pharmacokinetic Profile: T1/2 The Terminal Elimination Half-life for Period 1 & Period 2/End of Study

  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

  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

  Pre-dose (Period 1 Day 1 & Period 2 Day 113), Post-dose Period 1(Day 99) and post-dose Period 2 (Day 211)

Study Arms (5)

Period 1: CJM112 High Dose

EXPERIMENTAL

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

Period 1: Placebo

PLACEBO COMPARATOR

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

Period 2: CJM112 High Dose (Period 1) / Placebo (Period 2)

PLACEBO COMPARATOR

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

Period 2: Placebo (Period 1)/CJM112 Low Dose (Period 2)

EXPERIMENTAL

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

Period 2: Placebo (Period 1)/CJM112 High Dose (Period 2)

EXPERIMENTAL

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

Interventions

CJM112 BIOLOGICAL

CJM112 Fully human IgG1 monoclonal antibody

Period 1: CJM112 High Dose; Period 2: Placebo (Period 1)/CJM112 High Dose (Period 2); Period 2: Placebo (Period 1)/CJM112 Low Dose (Period 2)

Placebo DRUG

Period 1: Placebo; Period 2: CJM112 High Dose (Period 1) / Placebo (Period 2)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (16)

Novartis Investigative Site

Los Angeles, California, 90045, United States

Location

Novartis Investigative Site

Ormond Beach, Florida, 32174, United States

Location

Novartis Investigative Site

Tampa, Florida, 33609, United States

Location

Novartis Investigative Site

Atlanta, Georgia, 30342, United States

Location

Novartis Investigative Site

Indianapolis, Indiana, 46256, United States

Location

Novartis Investigative Site

Rockville, Maryland, 20850, United States

Location

Novartis Investigative Site

Boston, Massachusetts, 02114, United States

Location

Novartis Investigative Site

Omaha, Nebraska, 68144, United States

Location

Novartis Investigative Site

Nashville, Tennessee, 37215, United States

Location

Novartis Investigative Site

Roskilde, 4000, Denmark

Location

Novartis Investigative Site

Berlin, 10098, Germany

Location

Novartis Investigative Site

Bochum, 44791, Germany

Location

Novartis Investigative Site

Groningen, Netherlands

Location

Novartis Investigative Site

Rotterdam, 3015 CE, Netherlands

Location

Novartis Investigative Site

Basel, Switzerland

Location

Novartis Investigative Site

Zurich, CH-8091, Switzerland

Location

MeSH Terms

Conditions

Hidradenitis Suppurativa

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

8627788300

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2015
• First Posted: April 20, 2015
• Study Start: April 13, 2015
• Primary Completion: November 23, 2016
• Study Completion: November 23, 2016
• Last Updated: July 13, 2022
• Results First Posted: May 23, 2019

Record last verified: 2022-06

Locations

DE (2); US (9); DK (1); NL (2); CH (2)