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

Novartis

Status and phase: Completed; Phase 2

Conditions: Hidradenitis Suppurativa (Acne Inversa)

Treatments: Biological: CJM112; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02421172

CCJM112X2202

Details and patient eligibility

About

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.

Enrollment: 66 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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66 participants in 5 patient groups, including a placebo group

Period 1: CJM112 High Dose

Experimental group

Description:

Period 1: CJM112 High Dose subcutaneously (s.c.) weekly for 5 doses followed by bi-weekly for 5 doses for a total of 10 doses

Treatment:

Biological: CJM112

Period 1: Placebo

Placebo Comparator group

Description:

Period 1: Placebo subcutaneously (s.c.) weekly for 5 doses followed by bi-weekly for 5 doses for a total of 10 doses

Treatment:

Drug: Placebo

Period 2: CJM112 High Dose (Period 1) / Placebo (Period 2)

Placebo Comparator group

Description:

Period 2: Placebo subcutaneously (s.c.) weekly for 5 doses then bi-weekly for 5 doses for a total of 10 doses this group.This group was on CJM112 High Dose in Period 1

Treatment:

Drug: Placebo

Period 2: Placebo (Period 1)/CJM112 Low Dose (Period 2)

Experimental group

Description:

Period 2: CJM112 Low Dose subcutaneously (s.c.) weekly for 5 doses then bi-weekly for 5 doses for a total of 10 doses this group.This group was on Placebo in Period 1

Treatment:

Biological: CJM112

Period 2: Placebo (Period 1)/CJM112 High Dose (Period 2)

Experimental group

Description:

Period 2: CJM112 High Dose subcutaneously (s.c.) weekly for 5 doses then bi-weekly for 5 doses for a total of 10 doses this group.This group was on Placebo in Period 1

Treatment:

Biological: CJM112