- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01284569
Study to Assess Safety and Efficacy of Anti-Interleukin 6-receptor (IL6R) Nanobody in Rheumatoid Arthritis (RA) Patients
January 3, 2019 updated by: Ablynx
A Phase I/II, Randomised, Double-Blind, Placebo Controlled Study, Evaluating the Safety, Pharmacokinetics (PK), Pharmacodynamics (PD) and Efficacy of Single and Multiple Intravenous Doses of ALX-0061 in Patients With RA
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
65
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
|
Intravenous administration, single dose or multiple dose (once every 4 weeks or once every 8 weeks, for 12(/24) weeks; switch to ALX-0061 in weeks 13-24 if no response after first 12 weeks)
|
Experimental: ALX-0061
|
Intravenous administration, single dose (0.3-1-3-6-8 mg/kg) or multiple dose (Biologically effective dose, once every 4 weeks or once every 8 weeks, for 24 weeks)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Safety: number of treatment emergent adverse events (TEAEs)
Time Frame: From first study drug administration until last follow-up visit (i.e. 90 days after dosing for single dose part, 210 days after first dose for multiple dose part)
|
From first study drug administration until last follow-up visit (i.e. 90 days after dosing for single dose part, 210 days after first dose for multiple dose part)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pharmacokinetics (PK): serum concentration of ALX-0061
Time Frame: From first day prior to study drug administration until last follow-up visit (i.e. 90 days after dosing for single dose part, 210 days after first dose for multiple dose part)
|
From first day prior to study drug administration until last follow-up visit (i.e. 90 days after dosing for single dose part, 210 days after first dose for multiple dose part)
|
|
Biological efficacy: pharmacodynamic (PD) markers
Time Frame: From first day prior to study drug administration until last follow-up visit (i.e. 90 days after dosing for single dose part, 210 days after first dose for multiple dose part)
|
C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), serum amyloid A (SAA), fibrinogen, interleukin 6 (IL6), soluble IL6 receptor (sIL6R), tumour necrosis factor alpha (TNFalpha), interleukin 1 beta (IL1beta), interferon gamma (IFNgamma)
|
From first day prior to study drug administration until last follow-up visit (i.e. 90 days after dosing for single dose part, 210 days after first dose for multiple dose part)
|
Disease activity: RA-related assessments
Time Frame: From first day prior to study drug administration until last follow-up visit (i.e. 90 days after dosing for single dose part, 210 days after first dose for multiple dose part)
|
ACR response, DAS28 score, EULAR response
|
From first day prior to study drug administration until last follow-up visit (i.e. 90 days after dosing for single dose part, 210 days after first dose for multiple dose part)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2011
Primary Completion (Actual)
September 1, 2012
Study Completion (Actual)
September 1, 2012
Study Registration Dates
First Submitted
January 21, 2011
First Submitted That Met QC Criteria
January 26, 2011
First Posted (Estimate)
January 27, 2011
Study Record Updates
Last Update Posted (Actual)
January 4, 2019
Last Update Submitted That Met QC Criteria
January 3, 2019
Last Verified
January 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ALX-0061-1.1/10
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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-
Janssen Research & Development, LLCWithdrawnActive Rheumatoid Arthritis; Rheumatoid Arthritis
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Centocor, Inc.CompletedRheumatoid Arthritis, Juvenile
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AmgenTerminated
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Children's Hospital Medical Center, CincinnatiNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)CompletedJuvenile Rheumatoid ArthritisUnited States
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AmgenImmunex CorporationCompletedJuvenile Rheumatoid Arthritis
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University Hospital, ToulouseCompletedRheumatoId ArthritisFrance
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David Grant U.S. Air Force Medical CenterCompleted
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TcLand Expression S.A.European CommissionTerminatedRheumatoId ArthritisFrance, Netherlands, Turkey, Czechia, Israel
Clinical Trials on ALX-0061
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AblynxCompletedRheumatoid ArthritisSpain, Belgium, Bulgaria, Georgia, Germany, Hungary, Mexico, Moldova, Republic of, North Macedonia, Poland, Romania, Serbia
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AblynxCompletedLupus Erythematosus, SystemicUnited States, Hungary, Spain, Philippines, Poland, Serbia, Argentina, Chile, Czechia, Germany, Korea, Republic of, Mexico, Peru, Portugal, Russian Federation, Taiwan, Ukraine
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AblynxCompletedRheumatoid ArthritisCzechia, Bulgaria, Germany, Mexico, Poland, Romania, Serbia, Spain, Hungary, United States, Belgium, Georgia, Moldova, Republic of, North Macedonia
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Ralexar Therapeutics, Inc.CompletedAtopic Dermatitis | Eczema, AtopicUnited States
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Ablynx, a Sanofi companyCompletedAcquired Thrombotic Thrombocytopenic PurpuraUnited States, Australia, Austria, Belgium, Canada, Czechia, France, Germany, Hungary, Israel, Italy, Netherlands, Spain, Switzerland, Turkey, United Kingdom
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Ralexar Therapeutics, Inc.Unknown
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Allyx TherapeuticsMichael J. Fox Foundation for Parkinson's ResearchRecruitingParkinson DiseaseUnited States
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AblynxTerminated
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AblynxCompletedRespiratory Syncytial Virus Lower Respiratory Tract InfectionBelgium, Hungary, Israel, Spain, Estonia, Philippines, Thailand, Bulgaria, Poland, Germany, Chile, Colombia, Croatia, Czechia, Latvia, Malaysia, Slovakia