Study to Assess Safety and Efficacy of Anti-Interleukin 6-receptor (IL6R) Nanobody in Rheumatoid Arthritis (RA) Patients

Ablynx

Status and phase

Completed

Phase 2

Phase 1

Conditions

Rheumatoid Arthritis

Treatments

Biological: ALX-0061

Biological: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01284569

ALX-0061-1.1/10

Details and patient eligibility

About

The purpose of this study is to determine whether the ALX-0061, a Nanobody targeting the receptor for interleukin 6 (IL6R), is safe and effective after single or multiple administrations to patients with rheumatoid arthritis (RA). Patients will receive different single or multiple doses of either placebo or ALX-0061.

Enrollment

65 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Body mass index (BMI) <35.0 kg/m2
Diagnosed with rheumatoid arthritis (RA) according to the 2010 European League Against Rheumatism (EULAR)/ American College of Rheumatology (ACR) criteria for at least 6 months prior to randomisation
Treatment with methotrexate (MTX) for at least 12 weeks prior to screening, with at least 4 weeks before screening at a stable dose, that will remain stable throughout the study period. Inadequate response or or intolerance to disease modifying antirheumatic drugs (DMARDs) (including MTX, where a patient may remain on treatment with %TX at a lower dose for improved tolerance, but with reduced effectiveness)
For patients (men and women) of reproductive potential, use of an acceptable method of contraception for the duration of the study. Female patients must be willing to use appropriate birth control measures that would prevent pregnancy starting from the time of signing the informed consent until 90 days after the last dose of study drug is administered
For single dose part: Disease Activity Score using 28 joint counts (DAS28) score >= 2.4
For multiple dose part: DAS28 score >= 3.2
For multiple dose part: swollen joint count >= 3

Exclusion criteria

A documented history of an autoimmune disease other than RA (other than secondary Sjögren's syndrome)
Functional class IV by ACR classification
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
Suspicion of active tuberculosis verified by quantiferon test and abnormal chest X-ray
Female patients who are pregnant during the study, or are breastfeeding
History of anaphylactic reactions to protein therapeutics
Participation in an investigational drug study within 60 days prior to drug administration except for the patients who participated in the single dose part of this study and who are eligible to participate in the multiple dose part
Donation of more than 300 mL of blood within 60 days prior to drug administration
Malignancy, or prior malignancy, with a disease free interval of <5 years after diagnosis and intervention except curative treatment for non-melanoma skin cancer or resected carcinoma in situ
Any current or recent (within 4 weeks prior to first dose) signs or symptoms of infection that requires parenteral antibiotic administration, any known active viral infection (hepatitis B virus [HBV], hepatitis C virus [HCV], human immunodeficiency virus [HIV]) that would impair the participation in the study
Major surgery (including joint surgery) within 8 weeks prior to screening and hospitalisation for a clinically relevant event within the 4 weeks prior to screening
Any other disease, metabolic dysfunction, physical examination finding, or clinically significant laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or renders the patient at high risk for treatment complications
Administration of a live, attenuated vaccine within 1 month before dosing with ALX-0061, or anticipation that such a live attenuated vaccine will be required during the study or within 60 days after the last dose
For multiple dose part: contraindication to MRIs or the use of contrast agents for MRI scanning