Rheumatoid Arthritis (RA)Phase 1NCT02698657
A Study to Assess the Safety, Tolerability, and Pharmacokinetics of ASP5094 Following Multiple Intravenous Doses in Subjects With Rheumatoid Arthritis on Methotrexate
A Phase 1 study testing ASP5094 in people with Rheumatoid Arthritis (RA), run by Astellas Pharma Global Development, Inc. at 13 sites in 2 countries.
Trial summary
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of multiple ascending intravenous doses of ASP5094 in male and female subjects with rheumatoid arthritis (RA) on methotrexate (MTX). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Rheumatoid Arthritis (RA)
- What is being tested?
- ASP5094
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 13 sitesin 2 countries
- Study dates
- 23 Feb 2016to 7 Sep 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject has a body mass index (BMI) of ≤ 35 kg/m2, inclusive, and must weigh at least 50 kg at screening.
- Subject has absolute neutrophil count within normal limits at screening. The assessment may be repeated once during screening.
- Subject has RA that was diagnosed according to the 1987 revised criteria of the American College of Rheumatology (ACR) ≥ 6 months prior to screening.
- Subject meets the ACR 1991 revised criteria for Global Functional Status in RA, Class I, II or III at screening.
- Subject MUST be on concomitant MTX:
- for ≥ 3 months prior to day 1, and
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- at a stable dose (10 25 mg/week) for ≥ 28 days prior to day 1 and throughout the study.
- Subject's other medications taken for the treatment of RA at the time of screening must meet the noted stability requirements and remain on a stable regimen, as follows:
- Nonsteroidal antiinflammatory drugs (NSAIDs), selective cyclooxygenase-2 (COX- 2) inhibitors, oral corticosteroids (≤ 10 mg of prednisone, or equivalent, daily) or low dose opioids (≤ 30 mg of oral morphine, or equivalent, daily) must be stable for ≥ 28 days prior to screening,
- Hydroxychloroquine (Plaquenil®) and sulfasalazine (e.g., Azulfidine®) must have started ≥ 2 months, and be stable for ≥ 28 days, prior to day 1.
- Female subject must be either:
- Of nonchildbearing potential: postmenopausal (defined as at least 1 year without any menses) prior to screening, or documented surgically sterile
- Or, if of childbearing potential, Agree not to try to become pregnant during the study and for 60 days after the final study drug administration; must have a negative urine pregnancy test at screening and day 1, And, if heterosexually active, agree to consistently use 2 forms of highly effective birth control† (at least 1 of which must be a barrier method) starting at screening and throughout the study period and for 60 days after the final study drug administration.
- Female subject must agree not to breastfeed starting at screening and throughout the study period, and for 60 days.
- Female subject must not donate ova starting at screening and throughout the study period, and for 60 days after the final study drug administration.
- Male subject and his female spouse/partner who is of childbearing potential must be using highly effective forms of contraception consisting of 2 forms of birth control† (1 of which must be a barrier method) starting at screening and continue throughout the study period and for 60 days after the final study drug administration.
- Male subject must not donate sperm starting at screening and throughout the study period, and for 60 days after the final study drug administration
- Subject agrees not to participate in another interventional study while participating in the present study, defined as signing the informed consent form until completion of the last study visit.
Who cannot join
- Subject has an ongoing clinically significant systemic disease such as uncompensated heart failure, uncontrolled diabetes mellitus, severe hepatic failure, severe pulmonary disease or inflammatory bowel disease.
- Subject has a history of any malignancy in the past 5 years, except for adequately-treated, nonmelanoma skin cancer and adequately-treated in-situ cervical cancer.
- Subject has a history of severe allergic or anaphylactic reactions to drugs.
- Subject has a history of consuming more than 14 units of alcoholic beverages per week or has a history of alcoholism or drug/chemical/ substance abuse within past 6 months prior to screening (Note: 1 unit = 12 ounces of beer, 4 ounces of wine or 1 ounce of spirits).
- Subject has an ongoing infection or has had an infection requiring intravenous antibiotics within 1 month prior to day 1.
- Subject has a known history of a positive test for human immunodeficiency virus (HIV) antibody.
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- Subject has a past history of serious opportunistic infection.
- Subject has a positive QuantiFERON-TB Gold test within 90 days of, or at screening, and has not completed an adequate course of antimicrobial therapy per Centers for Disease Control or local guidelines.
- Subject's laboratory test results at screening or prior to study drug dosing on day 1:
- Outside the normal limits and considered by the investigator to be clinically significant with regard to the remaining per-protocol laboratory tests, and/or
- Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) are > 2 times the upper limit of normal.
- Subject received any live or live-attenuated vaccine within 30 days prior to day 1.
- Subject received any of the following:
- Oral or injectable gold, azathioprine, penicillamine, cyclosporine, tacrolimus or tofacitinib (Xeljanz®) within 30 days prior to day 1.
- Anakinra (Kineret®), etanercept (Enbrel®), adalimumab (Humira®), tocilizumab (Actemra®), infliximab (Remicade®), or golimumab (Simponi®) within 60 days prior to day 1.
- Leflunomide (Arava®) within 60 days prior to day 1, unless the subject has undergone cholestyramine washout at least 30 days prior to day 1.
- Certolizumab (Cimzia®) and abatacept (Orencia®) within 90 days prior to day 1.
- Rituximab (Rituxan®) or any other antiCD20 antibody, and cyclophosphamide within 180 days prior to day 1.
- Treatment with any other conventional disease modifying antirheumatic drugs (DMARDs), or treatment with any other biologics not previously noted within 28 days or 5 half-lives, whichever is longer, prior to day 1.
- Subject has participated in a previous clinical study with treatment with ASP5094 or has participated in another dose cohort of the current trial.
- Subject has previously received an experimental agent within 28 days or 5 half-lives, whichever is longer, prior to day 1.
- Subject has had any significant blood loss, donated 1 unit (450 mL) of blood or more, or received a transfusion of any blood or blood products within 60 days or donated plasma within 7 days prior to day 1.
- Subject had surgery or has a planned elective surgery (including oral surgery) within 1 month prior to screening and 3 months after last study drug administration.
- Subject has a wound that is currently healing.
- Subject has any other condition, which in the opinion of the investigator, precludes the subject's participation in the trial.
- Subject is an employee of the Astellas group or vendors involved in the study.
Trial locations and contacts
13 sites in 2 countries.
13 sites in 2 countries
United States7 sites
Site US10002
Anniston, Alabama, 36207
Site US10001
Dallas, Texas, 75231
Site US10008
DeBary, Florida, 32713-1818
Site US10003
Duncansville, Pennsylvania, 16635
Site US10004
Jacksonville, Florida, 32216
Site US10010
Memphis, Tennessee, 38119
Site US10009
Miami Lakes, Florida, 33014
Poland6 sites
Site PL48009
Elblag, 82-300
Site PL48011
Krakow, 31-637
Site PL48006
Lodz, 91-347
Site PL48007
Stalowa Wola
Site PL48003
Warsaw, 00-660
Site PL48008
Wroclaw, 50-556
About this study
Official title: A Phase 1, Randomized, Placebo-controlled, Dose Escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics of ASP5094 Following Multiple Intravenous Doses in Subjects With Rheumatoid Arthritis on Methotrexate
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of multiple ascending intravenous doses of ASP5094 in male and female subjects with rheumatoid arthritis (RA) on methotrexate (MTX).
- Conditions
- Rheumatoid Arthritis (RA)
- Being tested
- ASP5094, Placebo
- Keywords
- Rheumatoid arthritis (RA), Methotrexate, ASP5094
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASP5094Drug
Intravenous (IV)
PlaceboDrug
Intravenous (IV)
| Study group | Role | What they receive |
|---|---|---|
| ASP5094 Dose Escalation | Experimental | Three sequential cohorts will receive increasing intravenous doses of ASP5094. After all subjects in a cohort have completed study procedures the overall safety and tolerability of the dose will be determined after evaluation of the safety data. If there are no events which meet the stopping criteria, the next sequential cohort will begin enrollment while the current subjects continue through the third dose and the remainder of the study. Receives: Drug: ASP5094 |
| Placebo Dose Escalation | Placebo comparator | Three sequential cohorts will receive increasing intravenous doses of Placebo. After all subjects in a cohort have completed study procedures the overall safety and tolerability of the dose will be determined after evaluation of the safety data. If there are no events which meet the stopping criteria, the next sequential cohort will begin enrollment while the current subjects continue through the third dose and the remainder of the study. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Treatment-Emergent Adverse Events
A treatment-emergent adverse event (TEAE) is defined as a newly occurring or worsening adverse event (AE) observed after starting administration of study drug up until the end of study visit, inclusive. This includes abnormal laboratory tests, vital signs or electrocardiogram data that are defined as AEs if the abnormality induces clinical signs or symptoms, requires active intervention, interruption or discontinuation of study drug or is clinically significant in the investigator's opinion. A serious AE (SAE) is defined as an AE with an outcome that results in death, is life-threatening, results in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions, results in congenital anomaly, or birth defect or requires inpatient hospitalization or leads to prolongation of hospitalization.
Measured: From first dose of study drug up to end of study (up to 141 days)
Change from Baseline in Total Lymphocyte Counts
Measured: Baseline and days 29, 57, 85, 113, 141
Change from Baseline in Peripheral Lymphocyte Subsets: CD19
Measured: Baseline and days 29 (predose), 57 (predose), 85, 113, 141
Change from Baseline in Peripheral Lymphocyte Subsets: CD19/Lymphocytes
Measured: Baseline and days 29 (predose), 57 (predose), 85, 113, 141
Change from Baseline in Peripheral Lymphocyte Subsets: CD3
Measured: Baseline and Days 29 (predose), 57 (predose), 85, 113, 141
Change from Baseline in Peripheral Lymphocyte Subsets: CD3/Lymphocytes
Measured: Baseline and Days 29 (predose), 57 (predose), 85, 113, 141
Change from Baseline in Peripheral Lymphocyte Subsets: CD4
Measured: Baseline and Days 29 (predose), 57 (predose), 85, 113, 141
Change from Baseline in Peripheral Lymphocyte Subsets: CD4/Lymphocytes
Measured: Baseline and Days 29 (predose), 57 (predose), 85, 113, 141
Change from Baseline in Peripheral Lymphocyte Subsets: CD8
Measured: Baseline and Days 29 (predose), 57 (predose), 85, 113, 141
Change from Baseline in Peripheral Lymphocyte Subsets: CD8/Lymphocytes
Measured: Baseline and Days 29 (predose), 57 (predose), 85, 113, 141
Change from Baseline in Peripheral Lymphocyte Subsets: Granulocytes
Measured: Baseline and Days 29 (predose), 57 (predose), 85, 113, 141
Change from Baseline in Peripheral Lymphocyte Subsets: Granulocytes/Leukocytes
Measured: Baseline and Days 29 (predose), 57 (predose), 85, 113, 141
Change from Baseline in Peripheral Lymphocyte Subsets: Natural Killer Cell Subset/Lymphocytes
Measured: Baseline and Days 29 (predose), 57 (predose), 85, 113, 141
Change from Baseline in Peripheral Lymphocyte Subsets: Natural Killer Cells
Measured: Baseline and Days 29 (predose), 57 (predose), 85, 113, 141
Number of Participants with Anti-ASP5094 Antibody Formation
Measured: Days 1 (predose), 29 (predose), 57 (predose), 71, 85, 113 and 141
Area under the concentration-time curve from the time of dosing on day 1 to the end of the 4-week dosing interval for ASP5094 (AUC)
Measured: Day 1 predose, 0.5, 24, 96, 168, 216, 336, 504, 672 hours postdose
Maximum Concentration (Cmax) of ASP5094
Measured: Day 1 predose, 0.5, 24, 96, 168, 216, 336, 504, 672 hours postdose
Time to maximum concentration (tmax) of ASP5094
Measured: Day 1 predose, 0.5, 24, 96, 168, 216, 336, 504, 672 hours postdose
Concentration immediately prior to dosing at multiple dosing (Ctrough) for ASP5094
Measured: Predose on days 29, 57, and 85
Accumulation ratio calculated using the maximum concentration (R3ac[Cmax]) for ASP5094
Measured: Day 57 predose, 0.5, 24, 96, 168, 216, 336, 504, 672 hours postdose
Accumulation ratio calculated using the area under the concentration-time curve (R3ac[AUC]) for ASP5094
Measured: Day 57 predose, 0.5, 24, 96, 168, 216, 336, 504, 672 hours postdose
Secondary outcomes (4)
Terminal elimination half-life (t1/2)
Measured: Day 1 predose, 0.5, 24, 96, 168, 216, 336, 504, 672 hours postdose
Total clearance after intravenous dosing (CL)
Measured: Day 1 predose, 0.5, 24, 96, 168, 216, 336, 504, 672 hours postdose
Volume of distribution after intravenous dosing during the terminal elimination phase (VzF)
Measured: Day 1 predose, 0.5, 24, 96, 168, 216, 336, 504, 672 hours postdose
Percentage of Fluctuation
Measured: Day 1 predose, 0.5, 24, 96, 168, 216, 336, 504, 672 hours postdose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2016 (estimated)
- Study start23 Feb 2016
- Primary completion7 Sep 2017
- Study completion7 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid Arthritis (RA)Studies of the same condition, open and under way.
- More trials run by Astellas Pharma Global Development, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Global Development, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Senior Medical Director, Study director, Astellas Pharma Global Development, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02698657
- Sponsor's protocol ID
- 5094-CL-0102
- Other IDs
- 2015-004562-28, 2015
- Status last verified
- Oct 2024
- First submitted
- 10 Feb 2016
- Last updated
- 31 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Placebo-controlled, Dose Escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics of ASP5094 Following Multiple Intravenous Doses in Subjects With Rheumatoid Arthritis on Methotrexate
- ClinicalTrials.gov ID
- NCT02698657
- Acronym / sponsor ID
- 5094-CL-0102
- Conditions
- Rheumatoid Arthritis (RA)
- Keywords
- Rheumatoid arthritis (RA), Methotrexate, ASP5094
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Astellas Pharma Global Development, Inc.Industry (pharma, biotech, devices)
- Study start
- 23 Feb 2016 (actual)
- Primary completion
- 7 Sep 2017 (actual)
- Study completion
- 7 Sep 2017 (actual)
- First posted
- 4 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of multiple ascending intravenous doses of ASP5094 in male and female subjects with rheumatoid arthritis (RA) on methotrexate (MTX).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ASP5094 Dose Escalation | Experimental | Drug: ASP5094Three sequential cohorts will receive increasing intravenous doses of ASP5094. After all subjects in a cohort have completed study procedures the overall safety and tolerability of the dose will be determined after evaluation of the safety data. If there are no events which meet the stopping criteria, the next sequential cohort will begin enrollment while the current subjects continue through the third dose and the remainder of the study. |
| Placebo Dose Escalation | Placebo comparator | Drug: PlaceboThree sequential cohorts will receive increasing intravenous doses of Placebo. After all subjects in a cohort have completed study procedures the overall safety and tolerability of the dose will be determined after evaluation of the safety data. If there are no events which meet the stopping criteria, the next sequential cohort will begin enrollment while the current subjects continue through the third dose and the remainder of the study. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Subject has a body mass index (BMI) of ≤ 35 kg/m2, inclusive, and must weigh at least 50 kg at screening.
- Subject has absolute neutrophil count within normal limits at screening. The assessment may be repeated once during screening.
- Subject has RA that was diagnosed according to the 1987 revised criteria of the American College of Rheumatology (ACR) ≥ 6 months prior to screening.
- Subject meets the ACR 1991 revised criteria for Global Functional Status in RA, Class I, II or III at screening.
- Subject MUST be on concomitant MTX:
Key exclusion criteria (26 listed)
- Subject has an ongoing clinically significant systemic disease such as uncompensated heart failure, uncontrolled diabetes mellitus, severe hepatic failure, severe pulmonary disease or inflammatory bowel disease.
- Subject has a history of any malignancy in the past 5 years, except for adequately-treated, nonmelanoma skin cancer and adequately-treated in-situ cervical cancer.
- Subject has a history of severe allergic or anaphylactic reactions to drugs.
- Subject has a history of consuming more than 14 units of alcoholic beverages per week or has a history of alcoholism or drug/chemical/ substance abuse within past 6 months prior to screening (Note: 1 unit = 12 ounces of beer, 4 ounces of wine or 1 ounce of spirits).
- Subject has an ongoing infection or has had an infection requiring intravenous antibiotics within 1 month prior to day 1.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ASP5094Intravenous (IV) | Drug | ASP5094 Dose Escalation |
| PlaceboIntravenous (IV) | Drug | Placebo Dose Escalation |
Primary outcome
Number of Participants with Treatment-Emergent Adverse Events
Time frame: From first dose of study drug up to end of study (up to 141 days)
A treatment-emergent adverse event (TEAE) is defined as a newly occurring or worsening adverse event (AE) observed after starting administration of study drug up until the end of study visit, inclusive. This includes abnormal laboratory tests, vital signs or electrocardiogram data that are defined as AEs if the abnormality induces clinical signs or symptoms, requires active intervention, interruption or discontinuation of study drug or is clinically significant in the investigator's opinion. A serious AE (SAE) is defined as an AE with an outcome that results in death, is life-threatening, results in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions, results in congenital anomaly, or birth defect or requires inpatient hospitalization or leads to prolongation of hospitalization.
Change from Baseline in Total Lymphocyte Counts
Time frame: Baseline and days 29, 57, 85, 113, 141
Change from Baseline in Peripheral Lymphocyte Subsets: CD19
Time frame: Baseline and days 29 (predose), 57 (predose), 85, 113, 141
Change from Baseline in Peripheral Lymphocyte Subsets: CD19/Lymphocytes
Time frame: Baseline and days 29 (predose), 57 (predose), 85, 113, 141
Change from Baseline in Peripheral Lymphocyte Subsets: CD3
Time frame: Baseline and Days 29 (predose), 57 (predose), 85, 113, 141
Change from Baseline in Peripheral Lymphocyte Subsets: CD3/Lymphocytes
Time frame: Baseline and Days 29 (predose), 57 (predose), 85, 113, 141
Change from Baseline in Peripheral Lymphocyte Subsets: CD4
Time frame: Baseline and Days 29 (predose), 57 (predose), 85, 113, 141
Change from Baseline in Peripheral Lymphocyte Subsets: CD4/Lymphocytes
Time frame: Baseline and Days 29 (predose), 57 (predose), 85, 113, 141
Change from Baseline in Peripheral Lymphocyte Subsets: CD8
Time frame: Baseline and Days 29 (predose), 57 (predose), 85, 113, 141
Change from Baseline in Peripheral Lymphocyte Subsets: CD8/Lymphocytes
Time frame: Baseline and Days 29 (predose), 57 (predose), 85, 113, 141
Change from Baseline in Peripheral Lymphocyte Subsets: Granulocytes
Time frame: Baseline and Days 29 (predose), 57 (predose), 85, 113, 141
Change from Baseline in Peripheral Lymphocyte Subsets: Granulocytes/Leukocytes
Time frame: Baseline and Days 29 (predose), 57 (predose), 85, 113, 141
Change from Baseline in Peripheral Lymphocyte Subsets: Natural Killer Cell Subset/Lymphocytes
Time frame: Baseline and Days 29 (predose), 57 (predose), 85, 113, 141
Change from Baseline in Peripheral Lymphocyte Subsets: Natural Killer Cells
Time frame: Baseline and Days 29 (predose), 57 (predose), 85, 113, 141
Number of Participants with Anti-ASP5094 Antibody Formation
Time frame: Days 1 (predose), 29 (predose), 57 (predose), 71, 85, 113 and 141
Area under the concentration-time curve from the time of dosing on day 1 to the end of the 4-week dosing interval for ASP5094 (AUC)
Time frame: Day 1 predose, 0.5, 24, 96, 168, 216, 336, 504, 672 hours postdose
Maximum Concentration (Cmax) of ASP5094
Time frame: Day 1 predose, 0.5, 24, 96, 168, 216, 336, 504, 672 hours postdose
Time to maximum concentration (tmax) of ASP5094
Time frame: Day 1 predose, 0.5, 24, 96, 168, 216, 336, 504, 672 hours postdose
Concentration immediately prior to dosing at multiple dosing (Ctrough) for ASP5094
Time frame: Predose on days 29, 57, and 85
Accumulation ratio calculated using the maximum concentration (R3ac[Cmax]) for ASP5094
Time frame: Day 57 predose, 0.5, 24, 96, 168, 216, 336, 504, 672 hours postdose
Accumulation ratio calculated using the area under the concentration-time curve (R3ac[AUC]) for ASP5094
Time frame: Day 57 predose, 0.5, 24, 96, 168, 216, 336, 504, 672 hours postdose
4 secondary outcomes
Terminal elimination half-life (t1/2)
Time frame: Day 1 predose, 0.5, 24, 96, 168, 216, 336, 504, 672 hours postdose
Total clearance after intravenous dosing (CL)
Time frame: Day 1 predose, 0.5, 24, 96, 168, 216, 336, 504, 672 hours postdose
Volume of distribution after intravenous dosing during the terminal elimination phase (VzF)
Time frame: Day 1 predose, 0.5, 24, 96, 168, 216, 336, 504, 672 hours postdose
Percentage of Fluctuation
Time frame: Day 1 predose, 0.5, 24, 96, 168, 216, 336, 504, 672 hours postdose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2024.
- Individual participant dataSharing planned: No. Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Senior Medical Director study director
Astellas Pharma Global Development, Inc.
13 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ASP5094 in people with Rheumatoid Arthritis (RA), run by Astellas Pharma Global Development, Inc. at 13 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States, Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Treatment-Emergent Adverse Events (time frame: From first dose of study drug up to end of study (up to 141 days)). The study lists 21 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2024.