Phase 2
N=20
Efficacy and Safety Study of ACZ885 in Patients With Active Recurrent or Chronic TNF-receptor Associated Periodic Syndrome (TRAPS).
TNF-receptor Associated Periodic Syndromes (TRAPS)
Bottom Line
View on ClinicalTrials.gov: NCT01242813 ↗Enrolled (actual)
20
Serious AEs
35.0%
Results posted
Feb 2016
Primary outcome: Primary: Percentage of Participants With Complete or Almost Complete Response at Day 15 — 95 Percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- ACZ885 (Drug)
- Age
- Pediatric, Adult, Older Adult · 4+ yrs
- Sex
- All
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Jun 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Complete or Almost Complete Response at Day 15 |
95 | — |
| SECONDARY Percentage of Participants With Complete or Almost Complete Response at Day 8 |
80 | — |
| SECONDARY Percentage of Participants With Complete Clinical Remission at Day 8 and 15 |
90; 100 | — |
| SECONDARY Percentage of Participant With Target Levels of C-reactive Protein (CRP) and Serum Amyloid A Protein (SAA) at Day 8 and 15 |
35; 60 | — |
| SECONDARY Time to Physician's Assessed Clinical Remission |
4 | — |
| SECONDARY Percentage of Participants With Complete or Almost Complete Response at Day 15 After Receiving Additional Dose at Day 8 |
100 | — |
| SECONDARY Time to Participant's Assessed Clinical Remission |
3 | — |
| SECONDARY Percentage Change From Baseline in C-reactive Protein (CRP) and Serum Amyloid A (SAA) Concentration to End of Study |
-92.19; -96.54 | — |
| SECONDARY Percentage of Participants With Defined Grades for Skin Rash, Eye Manifestations, Extremity Pain and Abdominal Pain |
95; 5; 0; 0; 0; 90 | — |
| SECONDARY Percentage of Participants With Defined Grades in Physician's Global Assessment Score |
84.2; 10.5; 0; 0; 0 | — |
| SECONDARY Percentage of Participants With Defined Grades in Participant's Global Assessment Score |
41.7; 33.3; 8.3; 16.7; 0 | — |
| SECONDARY Percentage of Relapsed Participants |
0; 0; 0; 5; 0; 10 | — |
| SECONDARY Time to Relapse After Last Dose of Canakinumab |
91.5 | — |
| SECONDARY Percentage of Participants Who Relapsed and Received Rescue Medication |
25; 25; 10 | — |
| SECONDARY Serum Concentration of Canakinumab |
12.737; 13.874; 13.609; 9.911; 13.605; 15.291 | — |
| SECONDARY Serum Concentration of Total Interleukin-1β Antibody (IL-1β) |
12.616; 16.811; 10.662; 9.342; 10.701; 11.212 | — |
| SECONDARY Number of Participants With Anti-canakinumab Antibodies at Any Visit |
2 | — |
Summary
This trial will assess the safety and efficacy of ACZ885 in patients with active recurrent or chronic TNF-receptor associated periodic syndrome (TRAPS).
Eligibility Criteria
Inclusion Criteria
- Patient's written informed consent for >or= 18 years of age before any assessment is performed. Parent or legal guardian's written informed consent and child's assent, if appropriate, are required before any assessment is performed for patients or= 2) and an elevated CRP > 10mg/L (Normal CRP range 10 mg/L (Normal SAA range 5 mIU/mL).
- Women of child-bearing potential, defined as pre-menarche females aged 8 years and above or all women physiologically capable of becoming pregnant, UNLESS they are
- women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner
- women whose partners have been sterilized by vasectomy or other means
- using a highly effective method of birth control (i.e. one that results in a less than 1% per year failure rate when used consistently and correctly, such as implants, injectables, combined oral contraceptives, and some intrauterine devices [IUDs]; periodic abstinence [e.g. calendar, ovulation, symptothermal, post-ovulation methods] is not acceptable) or total abstinence at the discretion of the investigator in cases where the age, career, lifestyle, or sexual orientation of the patient ensures compliance.
- Women of child-bearing potential should be willing to use a reliable contraception throughout the study and for 3 months after study drug discontinuation.
- Women are considered post-menopausal and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or six months of spontaneous amenorrhea with serum FSH levels > 40 mIU/mL or have had surgical bilateral oophorectomy (with or without hysterectomy) at least six weeks ago. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment is she considered not of child bearing potential.
- History of being immunocompromised, including a positive HIV at screening (ELISA and Western blot) test result.
- Positive QuantiFERON (QFT-TB G In-Tube) test or positive Purified Protein Derivative (PPD) test (>or= 5 mm induration) at screening or within 2 month prior to the screening visit, according to the national guidelines. Patients with a positive PPD test (>or= 5 mm induration) at screening may be enrolled only if they have either a negative chest x-ray or a negative QuantiFERON test.
- Live vaccinations within 3 months prior to the start of the trial, during the trial, and up to 3 months following the last dose.
- History of significant other medical conditions, which in the Investigator's opinion would exclude the patient from participating in this trial.
- History of recurrent and/or evidence of active bacterial, fungal, or viral infection(s).
- Use of prohibited therapies, any other investigational biologics within 8 weeks prior to the Baseline visit, any other investigational drugs, other than investigational biologic treatment, within 30 days (or 3 months for investigational monoclonal antibodies) or 5 half-lives prior to the Baseline visit, whichever is longer
- History of known hypersensitivity to canakinumab.
- History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases
Other protocol defined inclusion/exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT01242813). 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.