NCT01284569

Brief Summary

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P75+ for phase_1 rheumatoid-arthritis

Timeline
Completed

Started Mar 2011

Typical duration for phase_1 rheumatoid-arthritis

Geographic Reach
3 countries

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 21, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 27, 2011

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2011

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

January 4, 2019

Status Verified

January 1, 2019

Enrollment Period

1.5 years

First QC Date

January 21, 2011

Last Update Submit

January 3, 2019

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

  • Safety: number of treatment emergent adverse events (TEAEs)

    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 Outcomes (3)

  • Pharmacokinetics (PK): serum concentration of ALX-0061

    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

    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

    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)

Study Arms (2)

ALX-0061

EXPERIMENTAL
Biological: ALX-0061

Placebo

PLACEBO COMPARATOR
Biological: Placebo

Interventions

ALX-0061BIOLOGICAL

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)

ALX-0061
PlaceboBIOLOGICAL

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)

Placebo

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Unknown Facility

Prague, Czechia

Location

Unknown Facility

Třinec, Czechia

Location

Unknown Facility

Budapest, Hungary

Location

Unknown Facility

Szeged, Hungary

Location

Unknown Facility

Krakow, Poland

Location

Unknown Facility

Warsaw, Poland

Location

Unknown Facility

Wroclaw, Poland

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

ALX-0061

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Josefin-Beate Holz, MD

    Ablynx NV

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 21, 2011

First Posted

January 27, 2011

Study Start

March 1, 2011

Primary Completion

September 1, 2012

Study Completion

September 1, 2012

Last Updated

January 4, 2019

Record last verified: 2019-01

Locations

CZ(2)PL(3)HU(2)