chronic joint inflammation Rheumatoid arthritis
Conditions
Interventions
Active substance: ALX-0061
Activity: anti-interleukin-6 receptor (IL-6R) nanobody inhibitor
Indication: rheumatoid arthritis
Dosage form: solution for injection/infusion
Sponsors
Ablynx
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Gender: male and female 2. Age: 18-80 years, inclusive 3. Body mass index (BMI):
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacodynamics Pharmakinetics Efficacy Safety parameters | — |
Countries
Netherlands
Outcome results
None listed