A Study of AK106-001616 in Patients With Rheumatoid Arthritis (RA)

Asahi Kasei Pharma Corporation130 enrolled

Overview

This will be a Phase II, multi-centre study consisting of 2 parts. Part 1: Clinical Pharmacology Study (drug-drug interaction between AK106-001616 and methotrexate) Part 2: Proof of Concept Study

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

130

Conditions

Rheumatoid Arthritis

Interventions

AK106-001616DRUG

Part1: Dose escalation Part2: Dose expansion

PlaceboDRUG

Active comparatorDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Diagnosis of RA (class I to III) * Stable dose of methotrexate (at least 12 weeks) Exclusion Criteria: * Pregnant or breastfeeding * Abnormal screening laboratory test values considered to be clinically significant

Locations (12)

Unnamed facility

Hlučín, Czechia

Unnamed facility

Prague, Czechia

Unnamed facility

Uherské Hradiště, Czechia

Unnamed facility

Frankfurt am Main, Hesse, Germany

Data from ClinicalTrials.gov

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