Rheumatoid arthritis MedDRA version: 14.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Conditions
Interventions
Product Name: ALX-0061
Product Code: ALX-0061
Pharmaceutical Form: Solution for infusion
Other descriptive name: ALX-0061 Nanobody
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type:
Sponsors
Ablynx NV
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: For SAD and MAD: 1. Gender: male and female 2. Age: 18-80 years, inclusive 3. Body mass index (BMI): = 2.4 For MAD: 8. DAS28 >= 3.2 9. Swollen joint count = 3 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 62 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: 1. A documented history of an autoimmune disease other than RA (other than secondary Sjögren’s syndrome) 2. Functional class IV by ACR classification 3. Any new/additional biologic DMARD therapy, cytotoxic drugs and immunosuppressants within four weeks prior to screening, and between screening and Day 1 with the exception of ALX-0061 4. Suspicion of active tuberculosis verified by quantiferon test and abnormal chest X-ray 5. Female patients who are pregnant during the study, or are breastfeeding 6. History of anaphylactic reactions to protein therapeutics 7. Participation in an investigational drug study within 60 days prior to drug administration except for the patients who participated in the SAD part of this study and who are eligible to participate in the MAD part 8. Donation of more than 300 mL of blood within 60 days prior to drug administration 9. Malignancy, or prior malignancy, with a disease free interval of 115 kilograms); patients who have a history of allergic reaction to contrast agents; patients who have had exposure to a radiological contrast agent within 72 hours prior to the MRI examination; patients with implanted electronic devices (e.g. heart pacemaker), insulin pump, cochlear implants, neural stimulators, intracranial or other internal vascular clips or intraocular metal foreign bodies; patients with severe renal insufficiency (i.e. glomerular filtration rate as estimated by creatinine clearance < 30 mL/min at screening) due to increased risk of Nephrogenic Systemic Fibrosis following administration of gadolinium-based MRI contrast agents. Careful consideration should be given to patients with: metallic endoprosthesis, metal sutures and foreign bodies in other locations than the examined one, and claustrophobia.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1. To investigate the safety and tolerability of single and multiple doses of ALX-0061 given by intravenous injection/infusion to patients with RA 2. To determine the maximum tolerated dose and/or biologically effective dose of ALX-0061 ;Secondary Objective: 1. To determine the efficacy of multiple dosing with ALX-0061 in patients with RA 2. To investigate the pharmacokinetics of ALX-0061 after single and multiple dosing in patients with RA 3. To investigate the pharmacodynamics of ALX-0061 after single and multiple dosing in patients with RA 4. To investigate the immunogenicity of ALX-0061 after single and multiple dosing in patients with RA ;Primary end point(s): As this is a phase I/II trial with only descripitve statistics, formal primary endpoints have not been statistically defined. Endpoints that will be assessed include: - evaluation of dose limiting toxicities (DLT) of ALX-0061 - evaluation of treatment-emergent adverse events of ALX-0061 - evaluation of pharmacokinetic and pharmacodynamic parameters for ALX-0061 - evaluation of the efficacy of multiple dosing with ALX-0061 in patients with RA - evaluation of immunogenicity of ALX-0061 ;Timepoint(s) of evaluation of this end point: 12 or 24 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable | — |
Countries
Czech Republic, Hungary
Contacts
Public ContactClinical Trials Information Desk
Ablynx NV
Outcome results
None listed