Overview

This trial is active, not recruiting.

Condition hidradenitis suppurativa (acne inversa)
Treatment cjm112
Phase phase 2
Sponsor Novartis Pharmaceuticals
Start date April 2015
End date November 2016
Trial size 66 participants
Trial identifier NCT02421172, CCJM112X2202

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Experimental)
CJM112 high dose in period 1; placebo in period 2
cjm112
Fully human IgG1 monoclonal antibody
(Experimental)
Placebo in period 1; CJM112 low dose in period 2
cjm112
Fully human IgG1 monoclonal antibody
(Experimental)
Placebo in period 1; CJM112 high dose in period 2
cjm112
Fully human IgG1 monoclonal antibody

Primary Outcomes

Measure
Clinical responder rate
time frame: Week 16

Secondary Outcomes

Measure
Safety and tolerability as measured by frequency of adverse events
time frame: Week 44
Clinical responder rate
time frame: Days 1 to week 44
Pharmacokinetic profile
time frame: Day 1 to Week 44
Immunogenicity
time frame: Day 1 to Week 44
Safety and tolerability as measured by safety laboratories
time frame: Week 44
Safety and tolerability as measured by physical exam
time frame: Week 44
Safety and tolerability as measured by vital signs
time frame: Week 44
Safety and tolerability as measured by ECG
time frame: Week 44
Pharmacodynamic profile as measured by questionnaires and lesion assements
time frame: Day 1 to Week 44

Eligibility Criteria

Male or female participants of any age.

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

Additional Information

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
Principal investigator R Hunger
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Novartis.