Phase 2
Completed N=66
Efficacy, Safety, and Pharmacokinetics Study of CJM112 in Hidradenitis Suppurativa Patients
Hidradenitis Suppurativa (Acne Inversa)
Source: ClinicalTrials.gov NCT02421172 ↗
Enrolled (actual)
66
Serious AEs
1.6%
Results posted
May 2019
Primary outcomePrimary: Clinical Responder Rate at Period 1: Week 16 — 10; 4 participants
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clinical Responder Rate at Period 1: Week 16 |
10; 4 | — |
| SECONDARY Clinical Responder Rate Period 1 at Week 2, 4, 8 and 12 |
4; 3; 6; 3; 5; 6 | — |
| SECONDARY Pharmacokinetics (PK): Ctrough for CJM112 Period 1 and Period 2 |
21.4; 3.1; 24.4 | — |
| SECONDARY Pharmacokinetic Profile: T1/2 The Terminal Elimination Half-life for Period 1 & Period 2/End of Study |
16.09; 22.81; 19.85 | — |
| 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 |
2; 1; 7; 1; 1; 0 | — |
| SECONDARY Total Interleukin-17A (IL-17A Homodimer) in Serum at Pre-dose and Post-dose for Period 1 & Period 2 |
361; 163; 158; 1160; 943; 821 | — |
Eligibility Criteria
Inclusion Criteria
- 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)
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT02421172). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.