Atrial FibrillationPhase 2NCT04213807
A Dose-range Finding Study of MAA868 in Patients With Atrial Fibrillation
A Phase 2 study testing MAA868 Cohort 1, MAA868 Cohort 2 and MAA868 Cohort 3 in people with Atrial Fibrillation, run by Anthos Therapeutics, Inc. at 6 sites in United States.
Trial summary
This study is a multicenter, randomized, subject and Investigator-blinded, placebo-controlled, parallel-group, multiple ascending dose-ranging study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) effects of MAA868 in patients with atrial fibrillation (AF) or flutter at low risk… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- MAA868 Cohort 1, MAA868 Cohort 2 and MAA868 Cohort 3
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 6 sitesUnited States
- Study dates
- 11 Dec 2019to 8 Mar 2021
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female patients ≥ 18 and < 85 years old with paroxysmal atrial fibrillation (PAF) or atrial flutter on 12 lead electrocardiography at Screening Or
- Patients with a history of PAF or atrial flutter, as documented by (telemetry, 12 lead electrocardiography or ambulatory [e.g. Holter] monitor) and not due to a reversible condition (e.g. alcohol binge drinking) can be entered even if they do not have PAF at Screening. There is not time-limit for this.
- Patients with a Congestive heart failure, Hypertension, Age ( > 65 = 1 point, > 75 = 2 points), Diabetes, previous Stroke/transient ischemic attack (2 points) (CHA2DS2-VASc) risk score (tool as a predictor for estimating the risk of stroke in patients with atrial fibrillation (AF); Lip et al 2010) of 0-1 for men and 1-2 for women and in whom, in the investigator's judgment, the use of an anticoagulant for stroke prevention is not indicated
Who cannot join
- History of stroke, transient ischemic attack or systemic embolism
- History of major bleeding during treatment with an anticoagulant or antiplatelet therapy. (Patients who have had major bleeding on anticoagulants or antiplatelet therapy more than a year ago can be enrolled only if the bleeding was due to a reversible cause, e.g. gastro-duodenal ulcer that was successfully treated.)
- History of traumatic or non-traumatic intracranial, intraspinal or intraocular bleeding
- Known bleeding diathesis or any known active bleeding site at screening or baseline
- Family history of bleeding disorder
- Known active GI lesions predisposing to bleeding events
Show all 10Show fewer
- Myocardial infarction, unstable angina pectoris or coronary artery bypass graft (CABG) surgery within 12 months prior to the Screening period
- Known clinically significant valvular heart disease including moderate or severe mitral stenosis (valve area <1.5 cm2)
- Patients with a prosthetic heart valve
- Other protocol defined Inclusion/Exclusion criteria may apply
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Anthos Investigative Site
Alexandria, Louisiana, 71301
Anthos Investigative Site
Beverly Hills, California, 90211
Anthos Investigative Site
Lansing, Michigan, 48912
Anthos Investigative Site
McKinney, Texas, 75069
Anthos Investigative Site
Wichita, Kansas, 67207
Anthos Investigative Site
Wynnewood, Pennsylvania, 19096
About this study
Official title: A Randomized, Placebo-controlled, Dose-range Finding Study to Assess the Pharmacokinetic and Pharmacodynamic Parameters, Safety, Tolerability, and Immunogenicity of MAA868 in Patients With Atrial Fibrillation
This study is a multicenter, randomized, subject and Investigator-blinded, placebo-controlled, parallel-group, multiple ascending dose-ranging study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) effects of MAA868 in patients with atrial fibrillation (AF) or flutter at low risk of thromboembolic stroke or peripheral embolism.
- Conditions
- Atrial Fibrillation
- Being tested
- MAA868 Cohort 1, MAA868 Cohort 2, MAA868 Cohort 3, Placebo
- Keywords
- atrial fibrillation, flutter, paroxysmal atrial fibrillation, stroke, cardiac arrhythmia
- Medical subject headings
- Atrial Fibrillation, Stroke, Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MAA868 Cohort 1Biological
Subcutaneous injection: low dose
MAA868 Cohort 2Biological
Subcutaneous injection: high dose
MAA868 Cohort 3Biological
Subcutaneous injection: Dose to be determined.
PlaceboOther
Subcutaneous injection: Placebo
| Study group | Role | What they receive |
|---|---|---|
| MAA868 | Experimental | Subcutaneous injection on Day 1 with two subsequent monthly injections Receives: Biological: MAA868 Cohort 1; Biological: MAA868 Cohort 2; Biological: MAA868 Cohort 3 |
| Placebo | Placebo comparator | Subcutaneous injection: Placebo on Day 1 with two subsequent monthly injections Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants That Achieved More Than or Equal to 50%, 80%, and 90% Factor XI Inhibition at Trough After the Third Dose (Day 91) at Different Dose Levels of MAA868
Number of participants achieving more than or equal to 50%, 80%, and 90% inhibition of factor XI (less than 50%, 20%, or 10% free factor XI) at trough after the third dose on Day 91 at different dose levels of MAA868
Measured: Day 91
Secondary outcomes (4)
Number of Participants Achieving More Than or Equal to 50%, 80%, and 90% Factor XI Inhibition at Trough After First (Day 31) and Second Doses (Day 61) at Different Dose Levels of MAA868
Number of participants achieving more than or equal to 50%, 80%, and 90% inhibition of factor XI (less than 50%, 20%, or 10% free factor XI) at trough on Day 31 (after first dose) and Day 61 (after second dose) at different dose levels of MAA868
Measured: Day 31 and Day 61
Overall Number of Participants Who Experienced Adverse Events, Including Serious Adverse Events, During the Treatment Period and Through End of Study
Overall number of participants who experienced adverse events following multiple subcutaneous administration of MAA868 compared to placebo in participants with atrial fibrillation or atrial flutter
Measured: Day 1 through end of study, up to 170 days
Incidence of Major Bleeding Events, Clinically Relevant Non-major Bleeding Events and Total Bleeding With MAA868 Relative to Placebo
Occurrence of confirmed major bleeding events, clinically relevant non-major bleeding events and total bleeding events during the treatment period
Measured: Day 1 through end of study, up to 170 days
Immunogenicity of MAA868
Number of participants with anti-drug (MAA868) antibodies for all participants who received MAA868 120 mg or MAA868 180 mg.
"Non-evaluable observation" refers to participants who had no sample collected (due to no visit or remote visit) or for whom the sample was not frozen.
Measured: Days 1, 31, 61, 71, 91, 121 and 170
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2019
- Study start11 Dec 2019
- Primary completion29 Dec 2020
- Study completion8 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anthos Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Covance
- Responsible party
- Sponsor
- Investigators
- Norman E Lepor, MD FACC FAHA FSCAI, Principal investigator, Westside Medical Associates of Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04213807
- Sponsor's protocol ID
- ANT-004
- Status last verified
- Dec 2021
- First submitted
- 23 Dec 2019
- Last updated
- 11 Jan 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo-controlled, Dose-range Finding Study to Assess the Pharmacokinetic and Pharmacodynamic Parameters, Safety, Tolerability, and Immunogenicity of MAA868 in Patients With Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT04213807
- Acronym / sponsor ID
- ANT-004
- Conditions
- Atrial Fibrillation
- Keywords
- atrial fibrillation, flutter, paroxysmal atrial fibrillation, stroke, cardiac arrhythmia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Anthos Therapeutics, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Covance
- Study start
- 11 Dec 2019 (actual)
- Primary completion
- 29 Dec 2020 (actual)
- Study completion
- 8 Mar 2021 (actual)
- First posted
- 30 Dec 2019 (actual)
- Results
- Posted 7 Dec 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a multicenter, randomized, subject and Investigator-blinded, placebo-controlled, parallel-group, multiple ascending dose-ranging study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) effects of MAA868 in patients with atrial fibrillation (AF) or flutter at low risk of thromboembolic stroke or peripheral embolism.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MAA868 | Experimental | Biological: MAA868 Cohort 1, Biological: MAA868 Cohort 2, Biological: MAA868 Cohort 3Subcutaneous injection on Day 1 with two subsequent monthly injections |
| Placebo | Placebo comparator | Other: PlaceboSubcutaneous injection: Placebo on Day 1 with two subsequent monthly injections |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male and female patients ≥ 18 and < 85 years old with paroxysmal atrial fibrillation (PAF) or atrial flutter on 12 lead electrocardiography at Screening Or
- Patients with a history of PAF or atrial flutter, as documented by (telemetry, 12 lead electrocardiography or ambulatory [e.g. Holter] monitor) and not due to a reversible condition (e.g. alcohol binge drinking) can be entered even if they do not have PAF at Screening. There is not time-limit for this.
- Patients with a Congestive heart failure, Hypertension, Age ( > 65 = 1 point, > 75 = 2 points), Diabetes, previous Stroke/transient ischemic attack (2 points) (CHA2DS2-VASc) risk score (tool as a predictor for estimating the risk of stroke in patients with atrial fibrillation (AF); Lip et al 2010) of 0-1 for men and 1-2 for women and in whom, in the investigator's judgment, the use of an anticoagulant for stroke prevention is not indicated
Key exclusion criteria (10 listed)
- History of stroke, transient ischemic attack or systemic embolism
- History of major bleeding during treatment with an anticoagulant or antiplatelet therapy. (Patients who have had major bleeding on anticoagulants or antiplatelet therapy more than a year ago can be enrolled only if the bleeding was due to a reversible cause, e.g. gastro-duodenal ulcer that was successfully treated.)
- History of traumatic or non-traumatic intracranial, intraspinal or intraocular bleeding
- Known bleeding diathesis or any known active bleeding site at screening or baseline
- Family history of bleeding disorder
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 |
|---|---|---|
| MAA868 Cohort 1Subcutaneous injection: low dose | Biological | MAA868 |
| MAA868 Cohort 2Subcutaneous injection: high dose | Biological | MAA868 |
| MAA868 Cohort 3Subcutaneous injection: Dose to be determined. | Biological | MAA868 |
| PlaceboSubcutaneous injection: Placebo | Other | Placebo |
Primary outcome
Number of Participants That Achieved More Than or Equal to 50%, 80%, and 90% Factor XI Inhibition at Trough After the Third Dose (Day 91) at Different Dose Levels of MAA868
Time frame: Day 91
Number of participants achieving more than or equal to 50%, 80%, and 90% inhibition of factor XI (less than 50%, 20%, or 10% free factor XI) at trough after the third dose on Day 91 at different dose levels of MAA868
4 secondary outcomes
Number of Participants Achieving More Than or Equal to 50%, 80%, and 90% Factor XI Inhibition at Trough After First (Day 31) and Second Doses (Day 61) at Different Dose Levels of MAA868
Time frame: Day 31 and Day 61
Overall Number of Participants Who Experienced Adverse Events, Including Serious Adverse Events, During the Treatment Period and Through End of Study
Time frame: Day 1 through end of study, up to 170 days
Incidence of Major Bleeding Events, Clinically Relevant Non-major Bleeding Events and Total Bleeding With MAA868 Relative to Placebo
Time frame: Day 1 through end of study, up to 170 days
Immunogenicity of MAA868
Time frame: Days 1, 31, 61, 71, 91, 121 and 170
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Norman E Lepor, MD FACC FAHA FSCAI principal investigator
Westside Medical Associates of Los Angeles
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MAA868 Cohort 1, MAA868 Cohort 2 and MAA868 Cohort 3 in people with Atrial Fibrillation, run by Anthos Therapeutics, Inc. at 6 sites in United States.
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 3 inclusion and 10 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 11 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Dec 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 That Achieved More Than or Equal to 50%, 80%, and 90% Factor XI Inhibition at Trough After the Third Dose (Day 91) at Different Dose Levels of MAA868 (time frame: Day 91). 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 11 Jan 2022.