Hidradenitis Suppurativa (Acne Inversa) Clinical Trial
Official title:
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
| Verified date | June 2022 |
| Source | Novartis |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 66 |
| Est. completion date | November 23, 2016 |
| Est. primary completion date | November 23, 2016 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Denmark | Novartis Investigative Site | Roskilde | |
| Germany | Novartis Investigative Site | Berlin | |
| Germany | Novartis Investigative Site | Bochum | |
| Netherlands | Novartis Investigative Site | Groningen | |
| Netherlands | Novartis Investigative Site | Rotterdam | |
| Switzerland | Novartis Investigative Site | Basel | |
| Switzerland | Novartis Investigative Site | Zurich | |
| United States | Novartis Investigative Site | Atlanta | Georgia |
| United States | Novartis Investigative Site | Boston | Massachusetts |
| United States | Novartis Investigative Site | Indianapolis | Indiana |
| United States | Novartis Investigative Site | Los Angeles | California |
| United States | Novartis Investigative Site | Nashville | Tennessee |
| United States | Novartis Investigative Site | Omaha | Nebraska |
| United States | Novartis Investigative Site | Ormond Beach | Florida |
| United States | Novartis Investigative Site | Rockville | Maryland |
| United States | Novartis Investigative Site | Tampa | Florida |
| Lead Sponsor | Collaborator |
|---|---|
| Novartis Pharmaceuticals |
United States, Denmark, Germany, Netherlands, Switzerland,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Clinical Responder Rate at Period 1: Week 16 | Proportion of study participants achieving a clinical response in Hidradenitis Suppurativa - Physician Global Assessment (HS-PGA) score An HS-PGA responder in period 1 was a participant who had an initial HS-PGA score of at least 3 at baseline (Day 1, inclusion criterion) that decreased by at least 2 points. The six-point Physician Global Assessment (PGA) (scores range from 0-5) based on the number of HS lesions ranges from clear to very severe. | Week 16 | |
| Secondary | Clinical Responder Rate Period 1 at Week 2, 4, 8 and 12 | Proportion of study participants achieving a clinical response in Hidradenitis Suppurativa - Physician Global Assessment (HS-PGA) score A HS-PGA responder in Period 1 is a study participant who had an initial HS-PGA score of at least 3 at Baseline (Day 1, inclusion criterion) that decreased by at least 2 points. The six-point Physician Global Assessment (PGA) (scores range from 0-5) based on the number of HS lesions ranges from clear to very severe. | Week 2, 4, 8 and 12 | |
| Secondary | Pharmacokinetics (PK): Ctrough for CJM112 Period 1 and Period 2 | Ctrough is the serum concentration that is just prior to the beginning of, or at the end, of a dosing interval (mass/volume) for Period 1 (week 16) and Period 2/End of Study (week 44) | Week 16 and Week 44 | |
| Secondary | Pharmacokinetic Profile: T1/2 The Terminal Elimination Half-life for Period 1 & Period 2/End of Study | T1/2 The terminal elimination half-life for Period 1 (Week 16) and Period 2/End of Study (Week 44) | Week 16 (period 1), Week 44 (End of Study Period 2) | |
| Secondary | Immunogenicity - Incidence of ADA-positive and ADA-negative in Participants With or Without Pre-existing Antibodies in Period 1 and Period 2/End of Study | Immunogenicity - Incidence of semi-quantitative determination of anti-CJM112 antibodies or ADAs. ADA-positive and ADA-negative in participants with or without pre-existing antibodies Period 1 (week 16) and Period 2/End of Study (week 44) | Week 16 (period 1), Week 44 (End of Study Period 2) | |
| Secondary | Total Interleukin-17A (IL-17A Homodimer) in Serum at Pre-dose and Post-dose for Period 1 & Period 2 | Total Interleukin-17A (IL-17A homodimer) in serum at Pre-dose Period 1 (Day 1) & Pre-dose Period 2 (Day 113) and Post-dose Period 1 (Day 99) and Post-dose Period 2 (Day 211) | Pre-dose (Period 1 Day 1 & Period 2 Day 113), Post-dose Period 1(Day 99) and post-dose Period 2 (Day 211) |