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

Novartis Pharmaceuticals66 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Hidradenitis Suppurativa (Acne Inversa)

Interventions

CJM112BIOLOGICAL

CJM112 Fully human IgG1 monoclonal antibody

PlaceboDRUG

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (16)

Novartis Investigative Site

Los Angeles, California, United States

Novartis Investigative Site

Ormond Beach, Florida, United States

Outcomes

Primary Outcomes

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.

Time frame: Week 16

Secondary Outcomes

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.

Time frame: 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)

Time frame: 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)

Time frame: 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)

Data from ClinicalTrials.gov

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