Chronic hidradenitis suppurativa MedDRA version: 19.0 Level: LLT Classification code 10020041 Term: Hidradenitis suppurativa System Organ Class: 100000004858
Conditions
Interventions
Product Code: CJM112
Pharmaceutical Form: Solution for injection
Current Sponsor code: CCJM112X2202
Other descriptive name: CJM112
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type:
Sponsors
Novartis Pharma Services AG
Eligibility
Sex/Gender
All
Inclusion 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 inflammatory abscesses and/or inflammatory 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) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 60 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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 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. Other protocol-defined inclusion/exclusion criteria may apply MORE STRINGENT CONTRACEPTION METHODS ARE ACCEPTABLE IN CASE REQUIRED AS PER LOCAL REGULATIONS.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the efficacy of CJM112 in chronic hidradenitis suppurativa (HS) patients by clinical responder rate at week 16;Secondary Objective: - To assess the safety and tolerability of CJM112 in patients with chronic hidradenitis suppurativa (HS) - To assess the efficacy of CJM112 in chronic HS patients, by clinical responder rate at time points other than week 16 - To evaluate the pharmacokinetics and pharmacodynamics (IL-17A (homodimer) capture) of CJM112 in HS patients after multiple s.c. administration - To assess immunogenicity (IG) ;Primary end point(s): Proportion of study participants achieving a clinical response in Hidradenitis Suppurativa - Physician Global Assessment (HS-PGA) score;Timepoint(s) of evaluation of this end point: Week 16 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Frequency of adverse events, safety laboratories, physical exam, vital signs, ECG - Proportion of study participants achieving a clinical response in Hidradenitis Suppurativa - Physician Global Assessment (HS-PGA) score - Anti-CJM112 antibodies in serum;Timepoint(s) of evaluation of this end point: Up to the end of the study | — |
Countries
Denmark, Germany, Netherlands, Switzerland, United States
Contacts
Public ContactMedizinischer Infoservice (MCC)
Novartis Pharma GmbH
Outcome results
None listed