NCT04246762 is a Phase 1 clinical trial of Olokizumab in Rheumatoid Arthritis, sponsored by R-Pharm International, LLC.

Who is sponsoring NCT04246762?

NCT04246762 is sponsored by R-Pharm International, LLC.

What drugs are being tested in NCT04246762?

Interventions in NCT04246762: Olokizumab, Omeprazole, Caffeine, Warfarin+ Vitamin K, Midazolam.

What condition does NCT04246762 study?

NCT04246762 studies Rheumatoid Arthritis.

Is NCT04246762 still recruiting?

NCT04246762 is currently completed. Last updated 15 August 2024.

Are results published for NCT04246762?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2024-08-15 · How we verify

NCT04246762

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

Study in Subjects With Rheumatoid Arthritis to Evaluate the Effect of a Single Dose of Olokizumab on the Pharmacokinetics of Substrates for CYP1A2, CYP2C9, CYP2C19 and CYP3A4

Completed Phase 1 Results posted Last updated 15 August 2024

What this trial tests

Phase 1 trial testing Olokizumab in Rheumatoid Arthritis in 17 participants. Completed in 26 October 2022.

Timeline

16 November 2021

Primary endpoint
8 June 2022

26 October 2022

Quick facts

Lead sponsor	R-Pharm International, LLC
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	17
Start date	16 November 2021
Primary completion	8 June 2022
Estimated completion	26 October 2022
Sites	2 locations across Bulgaria, Moldova

Drugs / interventions tested

Olokizumab
Omeprazole (omeprazole) — full drug profile →
Caffeine (caffeine) — full drug profile →
Warfarin+ Vitamin K — full drug profile →
Midazolam (midazolam) — full drug profile →

Conditions studied

Rheumatoid Arthritis — all drugs for Rheumatoid Arthritis →

Sponsor

R-Pharm International, LLC — full company profile →

Who can join

Adults 18 to 70, any sex, with Rheumatoid Arthritis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Olokizumab (OKZ) has been shown to reverse the inhibitory effect of IL-6 on the activity of Cytochrome P450 (CYP450) isozymes CYP1A2, CYP2B6, CYP2C9, CYP2C19, and CYP3A4/5 in vitro. The goal of the study was to assess the effect of OKZ on the pharmacokinetics (PK) of the CYP450 probe substrates, caffeine (CYP1A2), S-warfarin (CYP2C9), omeprazole (CYP2C19), and midazolam (CYP3A4) in subjects with rheumatoid arthritis (RA).

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of Olokizumab

Trials testing the same drug.

NCT05196477 — Study of the Outcomes of Olokizumab Therapy in Hospitalized Patients With SARS-CoV-2 (COVID-19) Infection · completed
NCT02760433 — Evaluation of the Efficacy and Safety of Two Dosing Regimens of Olokizumab (OKZ), Compared to Placebo, in Subjects With · Phase 3 · completed

Other recruiting trials for Rheumatoid Arthritis

Currently open trials in the same condition.

NCT07433335 — A Study to Assess the Safety and Tolerability of SR-878 in Patients With Rheumatoid Arthritis · Phase 1 · recruiting
NCT07491016 — Efficacy and Safety of Telitacicept Combined With Baricitinib for Refractory Rheumatoid Arthritis · recruiting
NCT07171983 — A Study to Evaluate the Safety, Tolerability, and Drug Levels of BMS-986454 in Participants With Rheumatoid Arthritis · Phase 1 · 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

Other R-Pharm International, LLC trials

Trials by the same sponsor.

NCT07206043 — Pharmacokinetics, Safety and Immunogenicity of RPH-104 at a New Dosage and Different Doses Via Single Subcutaneous and I · Phase 1 · completed
NCT06440746 — Efficacy and Safety of Olokizumab in Patients With Progressive Fibrosing Interstitial Lung Diseases · Phase 2, PHASE3 · recruiting
NCT04380519 — Study of the Efficacy and Safety of a Single Administration of Olokizumab and RPH-104 With Standard Therapy in Patients · Phase 2, PHASE3 · completed
NCT04692766 — Study to Evaluate the Efficacy and Safety of RPH-104 Treatment in Patients With Idiopathic Recurrent Pericarditis · Phase 2, PHASE3 · completed
NCT03120949 — Efficacy and Safety of Olokizumab in Subjects With Moderately to Severely Active Rheumatoid Arthritis · Phase 3 · completed

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 NCT04246762 (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 R-Pharm International, LLC
Last refreshed: 15 August 2024

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/NCT04246762.

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