NCT03487263 is a Phase 1 clinical trial of IC14 in Motor Neuron Disease, sponsored by Implicit Bioscience.

Who is sponsoring NCT03487263?

NCT03487263 is sponsored by Implicit Bioscience.

What drugs are being tested in NCT03487263?

Interventions in NCT03487263: IC14.

What condition does NCT03487263 study?

NCT03487263 studies Motor Neuron Disease, Amyotrophic Lateral Sclerosis.

Is NCT03487263 still recruiting?

NCT03487263 is currently completed. Last updated 20 August 2025.

Last reviewed 2025-08-20 · How we verify

NCT03487263

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Dose-Escalation, Safety and Pharmacokinetic Study of IC14 in Motor Neurone Disease

Completed Phase 1 Last updated 20 August 2025

What this trial tests

Phase 1 trial testing IC14 in Motor Neuron Disease in 10 participants. Completed in 30 December 2018.

Timeline

1 October 2017

Primary endpoint
18 April 2018

30 December 2018

Quick facts

Lead sponsor	Implicit Bioscience
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	10
Start date	1 October 2017
Primary completion	18 April 2018
Estimated completion	30 December 2018
Sites	1 location across Australia

Drugs / interventions tested

IC14 — full drug profile →

Conditions studied

Motor Neuron Disease — all drugs for Motor Neuron Disease →
Amyotrophic Lateral Sclerosis — all drugs for Amyotrophic Lateral Sclerosis →

Sponsor

Implicit Bioscience — full company profile →

Who can join

Adults 18 to 75, any sex, with Motor Neuron Disease or Amyotrophic Lateral Sclerosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Ten patients with motor neurone disease (MND, also known as amyotrophic lateral sclerosis or ALS) will be successively enrolled to one of two dose levels of IC14 (human chimeric monoclonal anti-CD14) intravenously for four doses. Patients must be within 3 years of MND diagnosis and have adequate respiratory function. Safety, tolerability, immunogenicity, and PK/PD will be measured. To evaluate feasibility of the endpoints, additional endpoints of ALSFRS-R, respiratory function tests, disease biomarkers and patient-reported outcomes will be measured.

Publications & conference data

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

Interplay between immunity and amyotrophic lateral sclerosis: Clinical impact.
De Marchi F, Munitic I, Amedei A, Berry JD, et al · · 2021 · cited 37× · PMID 34153344 · DOI 10.1016/j.neubiorev.2021.06.027
Phase 1b dose-escalation, safety, and pharmacokinetic study of IC14, a monoclonal antibody against CD14, for the treatment of amyotrophic lateral sclerosis.
Henderson RD, Agosti JM, McCombe PA, Thorpe K, et al · · 2021 · cited 11× · PMID 34678870 · DOI 10.1097/md.0000000000027421
CD14 Blockade Modulates Macrophage-Mediated Immunological Injury in a Translational Model of Reperfused ST-Segment Elevation Myocardial Infarction.
D'Elia Nee Brown AA, Kiriazis H, Bloom J, Noonan J, et al · · 2025 · cited 1× · PMID 41134248 · DOI 10.1016/j.jacbts.2025.101393

Verify or expand the search:

Other trials of IC14

Trials testing the same drug.

NCT06275893 — IC14 (Atibuclimab) in Arrhythmogenic Cardiomyopathy · Phase 1, PHASE2 · suspended
NCT03508453 — IC14 for Treatment of Amyotrophic Lateral Sclerosis · Phase 2 · withdrawn
NCT04488081 — I-SPY COVID-19 TRIAL: An Adaptive Platform Trial for Critically Ill Patients · Phase 2 · active not recruiting
NCT04309604 — IC14 for ALS Patients Expanded Access · no longer available

Other recruiting trials for Motor Neuron Disease

Currently open trials in the same condition.

NCT07204977 — Acamprosate in C9orf72 Hexanucleotide Repeat Expansion Amyotrophic Lateral Sclerosis (ACALS) · Phase 1 · active not recruiting
NCT06566651 — Emotion Processing Among Patients With ALS · recruiting
NCT05744310 — Effects of Long Term Ventilation Support on the Quality of Life of ALS Patients and Their Families · NA · recruiting
NCT06318598 — Biomarker-driven Phenotypic Dissection of Amyotrophic Lateral Sclerosis · recruiting
NCT06318585 — Creation of a Clinical Database for the Study of Phenotypic Variability in Motor Neuron Diseases · recruiting

Other Implicit Bioscience trials

Trials by the same sponsor.

NCT06678074 — Pilot Study of IC14 (Atibuclimab), an Anti-CD14 Monoclonal Antibody, to Treat STEMI · Phase 1, PHASE2 · active not recruiting
NCT06556810 — IC14 for Treatment of Acute Decompensated Heart Failure · Phase 1, PHASE2 · active not recruiting
NCT06275893 — IC14 (Atibuclimab) in Arrhythmogenic Cardiomyopathy · Phase 1, PHASE2 · suspended
NCT03508453 — IC14 for Treatment of Amyotrophic Lateral Sclerosis · Phase 2 · withdrawn
NCT03474263 — IC14 for Rapidly Progressive Amyotrophic Lateral Sclerosis (ALS) · Phase 2 · withdrawn

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03487263 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Implicit Bioscience
Last refreshed: 20 August 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03487263.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing