132 Participants Needed

ASP5502 for Sjögren's Syndrome

AP
Overseen ByAstellas Pharma Global Development, Inc.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you must stop taking your current medications, but it excludes participants using certain medications like immunosuppressants, B-cell depleting agents, and some others. It's best to discuss your specific medications with the trial team to see if they are allowed.

What is the purpose of this trial?

Primary Sjögren's syndrome (pSS) is a condition when the body's immune system attacks glands that produce fluids, such as the tear and saliva glands. This leads to dry eyes and a dry mouth. However, other symptoms may occur such as fatigue, joint pain, and skin problems. These symptoms can be severe. Symptoms can be treated but there is an unmet need to treat the actual condition.In this study, ASP5502 is being given to humans for the first time. The people taking part are healthy adults or adults with pSS. The main aims of the study are to check the safety of ASP5502 and how people tolerate ASP5502.This study will be in 3 parts. In Part 1, healthy men and women will take tablets of ASP5502 or a placebo just once. In this study, the placebo looks like the ASP5502 tablet but doesn't have any medicine in it. Different small groups of people will take a lower to a higher dose of ASP5502 or a placebo. This will happen one group after another. One small group will take tablets of ASP5502 or placebo with and without food. This is to find out if food affects how the body processes ASP5502.After their dose, people will stay in the medical center for a few nights. This is to have blood tests, electrocardiograms (ECGs) to check heart health, and other safety checks, and to report any medical problems. One of these checks is to have their heart continuously tracked during the first night. This is called telemetry. People who take tablets of ASP5502 or placebo with and without food will stay in the medical center for a few extra nights.In Part 2, healthy men and women will take tablets of ASP5502 or a placebo. They will do this once a day for 2 weeks (14 days). Different small groups of people will take a lower to a higher dose of ASP5502 or a placebo. This will happen one group after another.After taking ASP5502 or the placebo, people will stay in the medical center for a few nights. This is to have blood tests, ECGs to check heart health, and other safety checks, and to report any medical problems. Telemetry will also be done continuously during the first night.In Part 3, men and women with pSS will take tablets of ASP5502. They will do this once a day for 4 weeks (28 days). Different small groups of people will take a lower to a higher dose of ASP5502. This will either happen for one group after another, or just for 1 group. The number of groups and the doses taken will be worked out from the results from Part 1 and Part 2 of this study. People will stay in the medical center for a couple of nights. This will happen for their first dose, then again after about 2 weeks and 4 weeks of treatment. As in Parts 1 and 2, this is to have blood tests, ECGs to check heart health, and other safety checks, and to report any medical problems.In all parts of the study, people will return to the medical center about 1 week after their final blood sample is taken, for health check. People in parts 2 and 3 will also receive a telephone call safety check about 4 weeks after their last dose of ASP5502.

Research Team

MD

Medical Director

Principal Investigator

Astellas Pharma Global Development, Inc.

Eligibility Criteria

This trial is for healthy adults and those with Primary Sjögren's Syndrome, a condition causing dry eyes and mouth due to immune system attacks on fluid-producing glands. Participants will be given ASP5502 or a placebo to assess the drug's safety and how well they tolerate it.

Inclusion Criteria

Healthy Participants: Participant is healthy with no clinically significant medical conditions based on physical examination, ECG, and clinical laboratory tests
I am not pregnant and follow the required contraceptive guidelines.
I am a male with pSS and will use contraception and not donate sperm.
See 7 more

Exclusion Criteria

I have a history of significant health issues or surgeries.
Healthy Participants: Participant has positive QuantiFERON®-TB Gold test, history of drug/alcohol abuse, or abnormal lab values
I have secondary Sjögren's syndrome or another autoimmune disease.
See 10 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Part 1: Single Ascending Dose

Healthy participants receive a single oral dose of ASP5502 or placebo, with and without food, to evaluate safety and pharmacokinetics.

1 week
Multiple visits for dosing and monitoring

Part 2: Multiple Ascending Dose

Healthy participants receive daily oral doses of ASP5502 or placebo for 14 days to evaluate safety and pharmacokinetics.

2 weeks
Daily visits for dosing and monitoring

Part 3: Repeated Dose in Participants with pSS

Participants with primary Sjögren's syndrome receive daily oral doses of ASP5502 for 28 days to evaluate safety and pharmacokinetics.

4 weeks
Visits at start, 2 weeks, and 4 weeks for monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment, including a health check 1 week after the final blood sample and a telephone safety check 4 weeks after the last dose.

4 weeks
1 in-person visit, 1 telephone call

Treatment Details

Interventions

  • ASP5502
Trial Overview ASP5502 is being tested in three parts: single-dose administration in healthy individuals, repeated doses over two weeks in another healthy group, and daily dosing for four weeks in people with pSS. The study aims to determine the optimal dosage and evaluate food effects on drug processing.
Participant Groups
4Treatment groups
Experimental Treatment
Group I: Part 3 - Repeated Dose in Participants with pSSExperimental Treatment1 Intervention
Participants will receive daily oral doses of ASP5502 for 28 days.
Group II: Part 2 - Multiple Ascending Dose in Healthy participantsExperimental Treatment2 Interventions
Participants will receive daily oral doses of ASP5502 or placebo for 14 days.
Group III: Part 1 - Single Ascending Dose in Healthy participants (Food Effect Cohort)Experimental Treatment2 Interventions
Participants will receive a single oral dose of ASP5502 or Placebo under fasting conditions on period 1 Day 1 and single dose of ASP5502 or Placebo under fed conditions on period 2 Day 1.
Group IV: Part 1 - Single Ascending Dose in Healthy participants (Dose Escalation Cohort)Experimental Treatment2 Interventions
Participants will receive a single oral dose of ASP5502 or Placebo on Day 1.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Astellas Pharma Global Development, Inc.

Lead Sponsor

Trials
204
Recruited
123,000+

Tadaaki Taniguchi

Astellas Pharma Global Development, Inc.

Chief Medical Officer

M.D., Ph.D.

Naoki Okamura profile image

Naoki Okamura

Astellas Pharma Global Development, Inc.

Chief Executive Officer

Not available

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