NCT03189017 is a Phase 1 clinical trial of ICP-022 in Systemic Lupus Erythematosus, sponsored by Innocare Pharma Australia Pty Ltd.

Who is sponsoring NCT03189017?

NCT03189017 is sponsored by Innocare Pharma Australia Pty Ltd.

What drugs are being tested in NCT03189017?

Interventions in NCT03189017: ICP-022, Placebos.

What condition does NCT03189017 study?

NCT03189017 studies Systemic Lupus Erythematosus, Rheumatoid Arthritis.

Is NCT03189017 still recruiting?

NCT03189017 is currently completed. Last updated 1 August 2019.

Last reviewed 2019-08-01 · How we verify

NCT03189017

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

A Phase I Study of ICP-022 in Healthy Subjects

Completed Phase 1 Last updated 1 August 2019

What this trial tests

Phase 1 trial testing ICP-022 in Systemic Lupus Erythematosus in 64 participants. Completed in 30 October 2018.

Timeline

3 July 2017

Primary endpoint
5 February 2018

30 October 2018

Quick facts

Lead sponsor	Innocare Pharma Australia Pty Ltd
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	64
Start date	3 July 2017
Primary completion	5 February 2018
Estimated completion	30 October 2018
Sites	1 location across Australia

Drugs / interventions tested

ICP-022 — full drug profile →
Placebos — full drug profile →

Conditions studied

Systemic Lupus Erythematosus — all drugs for Systemic Lupus Erythematosus →
Rheumatoid Arthritis — all drugs for Rheumatoid Arthritis →

Sponsor

Innocare Pharma Australia Pty Ltd

Who can join

Adults 18 to 55, male only, with Systemic Lupus Erythematosus or Rheumatoid Arthritis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a single center, randomized, double-blind, placebo-controlled, dose escalation study in healthy subjects to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of ICP-022 following oral single and multiple escalating dose administration.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Development of a UPLC-MS/MS method for the determination of orelabrutinib in rat plasma and its application in pharmacokinetics.
Liu YN, Hu Y, Wang J, Chen C, et al · · 2022 · cited 2× · PMID 36147349 · DOI 10.3389/fphar.2022.991281

Verify or expand the search:

Other trials of ICP-022

Trials testing the same drug.

NCT05209620 — Orelabrutinib Combined With Pemetrexed For Relapsed/Refractory Central Nervous System Lymphoma · Phase 2 · recruiting
NCT04578613 — ICP-022 Versus Chlorambucil Combined With Rituximab in the Treatment of Untreated CLL/SLL · Phase 3 · unknown
NCT04305197 — A Study of ICP-022 in Patients With Systemic Lupus Erythematosus (SLE) · Phase 1, PHASE2 · completed
NCT04438005 — A Study of ICP-022 in Patients With R/R DLBCL · Phase 2 · completed
NCT04440059 — A Study of ICP-022 in the Treatment of Recurrent or Refractory Waldenstrom Macroglobulinemia · Phase 2 · completed

Other recruiting trials for Systemic Lupus Erythematosus

Currently open trials in the same condition.

NCT06984341 — A Study to Evaluate the Safety, Tolerability, Cellular Kinetics, Pharmacodynamics, and Efficacy of P-CD19CD20-ALLO1 in P · Phase 1 · recruiting
NCT07526350 — MTS109 in Patients With Refractory Autoimmune Diseases · EARLY_PHASE1 · recruiting
NCT07246096 — Exploratory Clinical Study on the Safety and Efficacy of Anti- CD19/BCMA U CAR-T Cell Injection for the Treatment of Rel · EARLY_PHASE1 · recruiting
NCT07363590 — A Clinical Study of MK-1045 in People With Lupus or Rheumatoid Arthritis (MK-1045-004) · Phase 1 · recruiting
NCT07371468 — A Study of GSK5926371 in Participants With B-cell Driven Autoimmune Rheumatic Diseases (ARD) · Phase 1 · recruiting

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 NCT03189017 (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 Innocare Pharma Australia Pty Ltd
Last refreshed: 1 August 2019

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/NCT03189017.

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