Overview

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

Status:
Completed

Trial end date:
2016-11-23

Target enrollment:
0

Participant gender:
All

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.

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Novartis Pharmaceuticals

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