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

Completed · Phase 2 · Has a placebo group

Conditions studied: Hidradenitis Suppurativa (Acne Inversa)

In brief

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.

Key facts

Study ID

NCT02421172

Run by

Novartis Pharmaceuticals

People needed

66

Starts

2015-04-13

Expected to finish

2016-11-23

Last updated by the study team

2022-07-13

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

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
• 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)

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.
• Other protocol-defined inclusion/exclusion criteria may apply

Where it is running

• Novartis Investigative Site — Los Angeles, California, United States
• Novartis Investigative Site — Ormond Beach, Florida, United States
• Novartis Investigative Site — Tampa, Florida, United States
• Novartis Investigative Site — Atlanta, Georgia, United States
• Novartis Investigative Site — Indianapolis, Indiana, United States
• Novartis Investigative Site — Rockville, Maryland, United States
• Novartis Investigative Site — Boston, Massachusetts, United States
• Novartis Investigative Site — Omaha, Nebraska, United States
• Novartis Investigative Site — Nashville, Tennessee, United States
• Novartis Investigative Site — Roskilde, Denmark
• Novartis Investigative Site — Berlin, Germany
• Novartis Investigative Site — Bochum, Germany
• Novartis Investigative Site — Groningen, Netherlands
• Novartis Investigative Site — Rotterdam, Netherlands
• Novartis Investigative Site — Basel, Switzerland
• Novartis Investigative Site — Zurich, Switzerland

Full record on ClinicalTrials.gov

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