NCT03613571 is a Phase 2 clinical trial of ILB in Amyotrophic Lateral Sclerosis, sponsored by TikoMed AB.

Who is sponsoring NCT03613571?

NCT03613571 is sponsored by TikoMed AB.

What drugs are being tested in NCT03613571?

Interventions in NCT03613571: ILB.

What condition does NCT03613571 study?

NCT03613571 studies Amyotrophic Lateral Sclerosis.

Is NCT03613571 still recruiting?

NCT03613571 is currently terminated. Last updated 12 June 2023.

Last reviewed 2023-06-12 · How we verify

NCT03613571

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

A Study to Evaluate the Safety, Tolerability and Efficacy of ILB in Patients With Amyotrophic Lateral Sclerosis

Terminated Phase 2 Last updated 12 June 2023

What this trial tests

Phase 2 trial testing ILB in Amyotrophic Lateral Sclerosis in 13 participants. Terminated before completion.

Timeline

15 August 2018

Primary endpoint
20 August 2019

20 August 2019

Quick facts

Lead sponsor	TikoMed AB
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	13
Start date	15 August 2018
Primary completion	20 August 2019
Estimated completion	20 August 2019
Sites	1 location across Sweden

Drugs / interventions tested

ILB — full drug profile →

Conditions studied

Amyotrophic Lateral Sclerosis — all drugs for Amyotrophic Lateral Sclerosis →

Sponsor

TikoMed AB — full company profile →

Who can join

Adults 18 to 80, any sex, with Amyotrophic Lateral Sclerosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a Phase 2a single-centre, open single-arm study in patients with Amyotrophic Lateral Sclerosis (ALS) of intermediate progression rate. Eligible subjects will be administered weekly doses of ILB. A total of 5 subcutaneous (s.c.) doses will be administered at the study clinic. The study consists of 10 visits; One 2-part screening visit, 5 ILB administration visits, and 3 follow-up visits. Each individual patient's study participation will be 4 months, including the screening and follow-up visits. Fifteen patients are planned to be included. The primary objective of the study is to evaluate the safety and tolerability of ILB in patients diagnosed with ALS. ILB is a solution for subcutaneous (s.c.) injection in saline solution. The dose administered will depend on the subject's body weight at the second study visit, prior to the first ILB administration. No formal sample size calculation has been performed for this study. The proposed sample size is considered sufficient in this early phase 2 development to provide adequate information on the patients. Categorical data will be presented as counts and percentages. Continuous data will be summarised using descriptive statistics.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other recruiting trials for Amyotrophic Lateral Sclerosis

Currently open trials in the same condition.

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NCT07204977 — Acamprosate in C9orf72 Hexanucleotide Repeat Expansion Amyotrophic Lateral Sclerosis (ACALS) · Phase 1 · active not recruiting
NCT07290062 — A Study to Investigate the Safety and Pharmacodynamics of a Single Intrathecal Injection (IT) of INS1202 in Participants · Phase 1 · recruiting
NCT07259980 — A Study to Learn More About the Long-Term Safety of Tofersen (Qalsody) in Participants With Superoxide Dismutase 1 (SOD- · recruiting

Other TikoMed AB trials

Trials by the same sponsor.

NCT03867851 — Study to Evaluate Safety and Efficacy of IBsolvMIR in Islet Transplantation · Phase 2 · terminated

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 NCT03613571 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by TikoMed AB
Last refreshed: 12 June 2023

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/NCT03613571.

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