NCT01284569

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

Completed Phase 1/Phase 2 Last updated 3 January 2019

What this trial tests

Phase 1/Phase 2 trial testing ALX-0061 in Rheumatoid Arthritis in 65 participants. Completed in 1 September 2012.

Timeline

1 March 2011

Primary endpoint
1 September 2012

1 September 2012

Quick facts

Lead sponsor	Ablynx, a Sanofi company
Phase	Phase 1/Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	65
Start date	1 March 2011
Primary completion	1 September 2012
Estimated completion	1 September 2012
Sites	7 locations across Czechia, Hungary, Poland

Drugs / interventions tested

• ALX-0061 — full drug profile →
• Placebo

Conditions studied

• Rheumatoid Arthritis — all drugs for Rheumatoid Arthritis →

Sponsor

Ablynx, a Sanofi company — full company profile →

Who can join

Adults 18 to 80, any sex, with Rheumatoid Arthritis. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• 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)

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. The Therapeutic Potential of Nanobodies.
   Jovčevska I, Muyldermans S. · · 2020 · cited 535× · PMID 31686399 · DOI 10.1007/s40259-019-00392-z
2. Bispecific antibodies and their applications.
   Fan G, Wang Z, Hao M, Li J. · · 2015 · cited 200× · PMID 26692321 · DOI 10.1186/s13045-015-0227-0
3. Potential therapeutic implications of IL-6/IL-6R/gp130-targeting agents in breast cancer.
   Heo TH, Wahler J, Suh N. · · 2016 · cited 95× · PMID 26840088 · DOI 10.18632/oncotarget.7102
4. Profile of sarilumab and its potential in the treatment of rheumatoid arthritis.
   Raimondo MG, Biggioggero M, Crotti C, Becciolini A, et al · · 2017 · cited 83× · PMID 28579757 · DOI 10.2147/dddt.s100302
5. Fc Engineering for Developing Therapeutic Bispecific Antibodies and Novel Scaffolds.
   Liu H, Saxena A, Sidhu SS, Wu D. · · 2017 · cited 70× · PMID 28184223 · DOI 10.3389/fimmu.2017.00038
6. Nanobodies: Robust miniprotein binders in biomedicine.
   Yong Joon Kim J, Sang Z, Xiang Y, Shen Z, et al · · 2023 · cited 46× · PMID 36754285 · DOI 10.1016/j.addr.2023.114726
7. Therapeutic Strategies for Immune Transformation in Parkinson's Disease.
   Saleh M, Markovic M, Olson KE, Gendelman HE, et al · · 2022 · cited 21× · PMID 35871362 · DOI 10.3233/jpd-223278
8. Application Progress of the Single Domain Antibody in Medicine.
   Tang H, Gao Y, Han J. · · 2023 · cited 20× · PMID 36835588 · DOI 10.3390/ijms24044176