A Phase II study of CA-702 in Patients with Sjogren's Syndrome

JRCT ID: jRCT2073210083

Registered date:22/10/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Primary Sjogren's Syndrome
• Date of first enrollment: 22/10/2021
• Target sample size: 20
• Study type: Interventional
• Intervention(s): locally Single injection of CA-702 or Placebo

Outcome(s)

• Primary Outcome: change in amount of saliva assessed by Saxon's test from baseline

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

- Diagnosed with primary Sjogren's Syndrome according to diagnostic criteria by Ministry of Health, Labour and Welfare Japan or ones by ACR- EULAR.
- Have subjective symptom of xerostomia.
- Amount of saliva assessed by Saxon's test is within a certain range.
- Ineffectiveness or intolerance to existing drugs(muscarinic agonists)

Exclude criteria

Diagnosed with secondary Sjogren's Syndrome or suspected to be.
Diagnosed with IgG4-related disease or suspected to be.
Only anti-centromere antibodies are positive.
Incapable of performing Saxon's test.
Blood test related to virus infections is positive.
Amount of saliva is suspected to be decreased by other than Sjogren's Syndrome.
Have had injection of E-MNC already.
Have participated in a clinical study of unapproved drug, medical product or medical device within 6-month before this study.

Related Information

• Primary Sponsor: Seki Makoto