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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03757065
Other study ID # ALPN000-001
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 12, 2019
Est. completion date October 25, 2019

Study information

Verified date August 2020
Source Alpine Immune Sciences, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study is designed to explore the expression of cell-surface markers in the following seven disease areas: (a) systemic lupus erythematosus, (b) Sjogren's syndrome, (c) multiple sclerosis, (d) systemic sclerosis, (e) Crohn's disease, (f) ulcerative colitis and (g) inflammatory myositis.


Recruitment information / eligibility

Status Completed
Enrollment 14
Est. completion date October 25, 2019
Est. primary completion date October 25, 2019
Accepts healthy volunteers No
Gender All
Age group 19 Years and older
Eligibility Inclusion Criteria:

1. Male or female participants 19 years of age or older.

2. Participant or legal surrogate able and willing to provide written, informed consent.

3. Participant is, or has been undergoing care for one of the specified diseases in a participating centre with a confirmed clinical diagnosis of the specified disease.

4. Participant has or will provide the relevant peripheral blood (required) and normal practice tissue specimens (if available).

5. Participant has one of the following target auto-immune or inflammatory diseases diagnosed according to local clinical practice guidelines:

1. Crohn's Disease

2. Inflammatory myositis

3. Multiple sclerosis

4. Sjogren's syndrome

5. Systemic lupus erythematosus

6. Systemic sclerosis

7. Ulcerative colitis

Exclusion Criteria:

1. Participants receiving investigational therapy within 30 days or 5 half-lives, whichever is longer, prior to enrolment.

2. Participants suffering from any additional disease that may interfere with the biomarker signals as per the investigator's discretion.

Study Design


Locations

Country Name City State
Canada GI Research Institute Vancouver British Columbia
Canada Mary Pack Arthritis Center Vancouver

Sponsors (1)

Lead Sponsor Collaborator
Alpine Immune Sciences, Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary CD28 Expression Percentage of CD28+ T cells in peripheral blood At enrollment
Primary ICOS Expression Percentage of ICOS+ T cells in peripheral blood At enrollment
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