Clinical trial NCT02421172: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hidradenitis Suppurativa (Acne Inversa)
Keywords: Hidradenitis Suppurativa
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2015-04-20
Enrollment: 66
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Clinical Responder Rate at Period 1: Week 16
timeFrame: Week 16
Secondary outcomes:
measure: Clinical Responder Rate Period 1 at Week 2, 4, 8 and 12
timeFrame: Week 2, 4, 8 and 12
measure: Pharmacokinetics (PK): Ctrough for CJM112 Period 1 and Period 2
timeFrame: Week 16 and Week 44
measure: Pharmacokinetic Profile: T1/2 The Terminal Elimination Half-life for Period 1 & Period 2/End of Study
timeFrame: Week 16 (period 1), Week 44 (End of Study Period 2)
measure: 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
timeFrame: Week 16 (period 1), Week 44 (End of Study Period 2)
measure: Total Interleukin-17A (IL-17A Homodimer) in Serum at Pre-dose and Post-dose for Period 1 & Period 2
timeFrame: Pre-dose (Period 1 Day 1 & Period 2 Day 113), Post-dose Period 1(Day 99) and post-dose Period 2 (Day 211)
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Novartis Investigative Site
state: California
city: Ormond Beach
country: United States
facility: Novartis Investigative Site
state: Florida
city: Tampa
country: United States
facility: Novartis Investigative Site
state: Florida
city: Atlanta
country: United States
facility: Novartis Investigative Site
state: Georgia
city: Indianapolis
country: United States
facility: Novartis Investigative Site
state: Indiana
city: Rockville
country: United States
facility: Novartis Investigative Site
state: Maryland
city: Boston
country: United States
facility: Novartis Investigative Site
state: Massachusetts
city: Omaha
country: United States
facility: Novartis Investigative Site
state: Nebraska
city: Nashville
country: United States
facility: Novartis Investigative Site
state: Tennessee
city: Roskilde
country: Denmark
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Bochum
country: Germany
facility: Novartis Investigative Site
city: Groningen
country: Netherlands
facility: Novartis Investigative Site
city: Rotterdam
country: Netherlands
facility: Novartis Investigative Site
city: Basel
country: Switzerland
facility: Novartis Investigative Site
city: Zurich
country: Switzerland
facility: Novartis Investigative Site
Study officials:
affiliation: University of Bern, Switzerland
name: R Hunger
role: PRINCIPAL_INVESTIGATOR
affiliation: Zurich University Hospital, Switzerland
name: Lars French
role: PRINCIPAL_INVESTIGATOR
affiliation: Erasmus MC, Rotterdam, Netherlands
name: E P Prens
role: PRINCIPAL_INVESTIGATOR
affiliation: Dermatologisk Afdeling, Roskilde, Denmark
name: Gregor Jemec
role: PRINCIPAL_INVESTIGATOR
affiliation: Psoriasis Research and Treatment Center, Charité hospital, Berlin, Germany
name: Sylke Schneider-Burrus
role: PRINCIPAL_INVESTIGATOR
affiliation: Dessau Medical Center, Department of Dermatology, Venerology, Allergology and Immunology, Germany
name: Christos C Zouboulis
role: PRINCIPAL_INVESTIGATOR
affiliation: Ruhr-University Bochum, Germany
name: Falk G Bechara
role: PRINCIPAL_INVESTIGATOR
affiliation: University Medical Center Groningen, NL
name: Barbara Horváth
role: PRINCIPAL_INVESTIGATOR
affiliation: Dermatologie AMC, Amsterdam, NL
name: Jan Mekkes
role: PRINCIPAL_INVESTIGATOR
affiliation: Dermato-verenologisk afdeling S, Denmark
name: Christian Vestergaard
role: PRINCIPAL_INVESTIGATOR
References: