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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00902369

Enrollment

130

Registered

2009-05-15

Start date

2009-05-31

Completion date

2010-07-31

Last updated

2016-07-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis

Keywords

AK106-001616

Brief summary

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

Interventions

DRUGAK106-001616

Part1: Dose escalation Part2: Dose expansion

DRUGPlacebo

DRUGActive comparator

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Countries

Czechia, Germany, Hungary, Lithuania, Romania, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 5, 2026