[No standalone website (unbranded, no questionnaire)] A Study of Subjects With Psoriatic Arthritis to Investigate the Effectiveness of Adalimumab Introduction Compared With Methotrexate Dose Escalation (CONTROL)

How to apply

Determine if a study site for this clinical trial is near you. Contact the study to apply.

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Study’s contact

Call center

919-433-1600

Email address

Clinical@KowaUS.com

Condition

NASH

Treatment type

Interventional

Investigational product

CSG452

Phase

Phase 2

Sponsor

Kowa Research Institute, Inc.

ClinicalTrials.gov identifier

NCT05327127

Study number

K-001-201

Understanding clinical trials

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About the study

A study to investigate the use of combination therapy with two investigational products for the treatment of adult patients with Nonalcoholic steatohepatitis (NASH).

Who can take part?

You may be eligible to participate in the study if you meet the following criteria:

Inclusion criteria

  1. Able to understand and comply with study procedures and give written informed consent
  2. Age ≥18 years
  3. NAS ≥4 with a score of at least 1 in each component of the NAS (steatosis, lobular inflammation, and ballooning) at Visit 2 liver biopsy, or a historical liver biopsy performed within 12 weeks of randomization
  4. Fibrosis stage of 1 or greater and below 4 on NASH CRN (Clinical Research Network) fibrosis staging system at Visit 2 liver biopsy, or a historical liver biopsy performed within 12 weeks of randomization
  5. Meet all inclusion criteria outlined in clinical study protocol
Exclusion criteria

  1. Participation in another clinical trial involving an investigational agent within 30 days prior to signing the Informed Consent Form (ICF) for this study
  2. Ongoing or recent consumption of significant amounts of alcohol as defined in clinical study protocol
  3. Evidence of other forms of chronic liver disease as defined in clinical study protocol
  4. Does not meet any other exclusion criteria outlined in clinical study protocol

For a full list of inclusion/exclusion criteria, please visit ClinicalTrials.gov

Study locations

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How to apply

Determine if a study site for this clinical trial is near you. Contact the study to apply.

Find a Study Site