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

Phase 2

Completed

Conditions: Hidradenitis suppurativa
Purulent hairfollicle inflamation
10040790

Registration Number: NL-OMON41960

Lead Sponsor: ovartis

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 15

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 inflammatory 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).;See protocol for other criteria and more details.

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 priorto randomization
3. Presence of more than 25 draining fistulae at baseline.
4. Surgical treatment for HS in the last 4 weeks prior to randomization/first treatment.
5. Women of childbearing 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.;See protocol for other criteria and more details.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>1. Clinical responder rate is the proportion (%) of study participants<br /><br>achieving at least a 2 point reduction in hidradenitis suppurativa - Physician<br /><br>Global Assessment (HS-PGA) score</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>2. All safety measures: Physical exam, vital signs, ECG, adverse events (in<br /><br>particular infections), safety laboratories.<br /><br>3. Clinical responder rate is the proportion (%) of study participants<br /><br>achieving at least a 2 point reduction from baseline in Hidradenitis<br /><br>Suppurativa - Physician Global Assessment (HS-PGA) score.<br /><br>4. Blood collection for total CJM112, total IL-17A (homodimer) and total<br /><br>IL-17AF (heterodimer) in serum.<br /><br>5. Blood collection for anti-CJM112 antibodies in serum.</p><br>