ASP5502 for Sjögren's Syndrome

Overseen By Astellas Pharma Global Development, Inc.

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Astellas Pharma Global Development, Inc.

Must not be taking: Immunosuppressants, B-cell depleting, JAK inhibitors, others

Disqualifiers: Secondary Sjögren's, Severe complications, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

132 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment, ASP5502, for primary Sjögren's syndrome (pSS), a condition where the immune system attacks fluid-producing glands, causing dry eyes and mouth, and possibly fatigue and joint pain. The trial evaluates the safety of ASP5502 and its tolerability. It consists of three parts: the first two involve healthy adults, and the third involves adults diagnosed with pSS for at least six months. Those with pSS who experience symptoms like dry mouth and eyes may be suitable for the third part of this trial. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the chance to be among the first to receive this new treatment.

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.

Is there any evidence suggesting that ASP5502 is likely to be safe for humans?

Research has shown that ASP5502 is undergoing its first human trials. The main goal is to assess its safety and tolerance in participants. As this is an early study, no prior information exists on ASP5502's safety in humans, necessitating close monitoring for any side effects.

Participants will stay in a medical center for a few nights, undergoing blood tests and heart checks, such as electrocardiograms (ECGs), to identify any issues. They will also report any problems they experience. Continuous heart monitoring will occur on the first night. These measures help track potential side effects.

The study includes both healthy adults and individuals with primary Sjögren's syndrome. Researchers will test different doses of ASP5502, starting low and gradually increasing. This careful approach helps determine how varying amounts affect safety. It is important to note that, as this is an early trial, safety information from humans is still being collected, which means there may be unknown risks. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for Sjögren's syndrome?

Unlike the standard treatments for Sjögren's Syndrome, which often include symptomatic relief with drugs like corticosteroids and hydroxychloroquine, ASP5502 works differently by targeting a new mechanism. Researchers are excited about ASP5502 because it offers a novel approach to modulating the immune response, which could potentially address the underlying causes of the disease rather than just managing symptoms. Additionally, ASP5502 is administered orally, which might offer a more convenient option compared to treatments that require injections or infusions. This could lead to improved patient compliance and overall quality of life for those affected by the condition.

What evidence suggests that ASP5502 might be an effective treatment for Sjögren's syndrome?

Research shows that ASP5502 is being tested as a treatment for primary Sjögren's syndrome (pSS). This condition occurs when the immune system mistakenly attacks the glands that produce fluids like tears and saliva, causing symptoms such as dry eyes and mouth. As ASP5502 is a new treatment, no data yet exists on its effectiveness in people. The treatment might help by calming the immune system's attack on these glands. In this trial, some participants will receive single or multiple doses of ASP5502, while others may receive a placebo. Early studies mainly focus on assessing its safety and how well the body tolerates it. ^{1 2 3 4 6}

Who Is on the Research Team?

Medical Director

Principal Investigator

Astellas Pharma Global Development, Inc.

Are You a Good Fit for This Trial?

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.

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

Participants with pSS: Participant has abnormal vital signs, positive tests for alcohol/drugs, or known hypersensitivity

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Part 3 - Repeated Dose in Participants with pSS Experimental Treatment 1 Intervention

Participants will receive daily oral doses of ASP5502 for 28 days.

Group II: Part 2 - Multiple Ascending Dose in Healthy participants Experimental Treatment 2 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 Treatment 2 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 Treatment 2 Interventions

Participants will receive a single oral dose of ASP5502 or Placebo on Day 1.

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

Astellas Pharma Global Development, Inc.

Chief Executive Officer

Not available

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06544642

A Study to Evaluate the Effects of ASP5502 in Healthy ... Participant has severe complications of Sjögren's syndrome, such as neurologic or cardiac involvement, interstitial lung disease and severe myositis.

2. trials.arthritis.org trials.arthritis.org/trials/NCT06544642

A Study to Evaluate the Effects of ASP5502 in Healthy Adults ... 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 ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S152169422500052X

Novel therapies in Sjögren's disease: A systematic review ... This systematic review aims to provide a comprehensive overview of recent SjD therapeutic advances, assess trial inclusivity with respect to sex/gender and ...

4. withpower.com withpower.com/trial/phase-1-healthy-subjects-hs-7-2024-9bff3

ASP5502 for Sjögren's Syndrome This Phase 1 medical study run by Astellas Pharma Global Development, Inc. is evaluating whether ASP5502 will have tolerable side effects & efficacy for ...

5. ja.clinicaltrials.astellas.com ja.clinicaltrials.astellas.com/study/5502-CL-0001

A study to evaluate the effects of ASP5502 in healthy adults ... 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 ...

6. adisinsight.springer.com adisinsight.springer.com/trials/700375768

A Phase 1 Combined Single and Multiple Ascending Oral ... A Phase 1 Combined Single and Multiple Ascending Oral Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Food Effect and ...