Hypertrophic Cardiomyopathy (HCM)Phase 2REDWOOD-HCMNCT04219826
Dose-finding Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CK-3773274 in Adults With Hypertrophic Cardiomyopathy
A Phase 2 study testing CK-3773274 (5 - 15 mg) and CK-3773274 (10 - 30 mg) in people with Hypertrophic Cardiomyopathy (HCM), run by Cytokinetics at 22 sites in 4 countries.
Trial summary
This study is being performed to understand the effect of different doses of CK-3773274 on patients with hypertrophic cardiomyopathy (HCM). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Hypertrophic Cardiomyopathy (HCM)
- What is being tested?
- CK-3773274 (5 - 15 mg) and CK-3773274 (10 - 30 mg)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- 22 sitesin 4 countries
- Study dates
- 10 Jan 2020to 28 Feb 2023
- 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
- Males and females between 18 and 85 years of age at screening.
- Body weight is ≥45 kg at screening.
- Diagnosed with HCM per the following criteria:
- Has left ventricular (LV) hypertrophy with non-dilated LV chamber in the absence of other cardiac disease.
- Has minimal wall thickness ≥15 mm (minimal wall thickness ≥13 mm is acceptable with a positive family history of HCM or with a known disease-causing gene mutation).
- Adequate acoustic windows for echocardiography.
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- For Cohorts 1, 2 and 3 has LVOT-G during screening as follows:
- Resting gradient ≥50 mmHg OR
- Resting gradient ≥30 mmHg and <50 mmHg with post-Valsalva LVOT-G ≥50 mmHg
- For Cohort 4 has resting and post-Valsalva LVOT-G < 30 mmHg at the time of screening
- For Cohort 4 has elevated NT-proBNP > 300 pg/mL at the time of screening
- LVEF ≥60% at screening.
- New York Heart Association (NYHA) Class II or III at screening.
- Patients on beta-blockers, verapamil, diltiazem, or ranolazine should have been on stable doses for >4 weeks prior to randomization and anticipate remaining on the same medication regimen during the study.
- For Cohort 3: Patients must be taking disopyramide. Patients should have been on stable disopyramide doses for >4 weeks prior to screening and anticipate remaining on the same medication regimen during the study.
Who cannot join
- Aortic stenosis or fixed subaortic obstruction.
- Known infiltrative or storage disorder causing cardiac hypertrophy that mimics oHCM (eg, Noonan syndrome, Fabry disease, amyloidosis).
- History of LV systolic dysfunction (LVEF <45%) at any time during their clinical course.
- Documented history of current obstructive coronary artery disease (>70% stenosis in one or more epicardial coronary arteries) or documented history of myocardial infarction.
- Has been treated with septal reduction therapy (surgical myectomy or percutaneous alcohol septal ablation) or has plans for either treatment during the study period (Cohorts 1, 2, and 3 only). Patients having undergone septal reduction therapy > 12 months prior to screening who remain symptomatic from nHCM, and who meet all other criteria for inclusion, may be enrolled in Cohort 4.
- For Cohorts 1, 2 and 4: Has been treated with disopyramide or antiarrhythmic drugs that have negative inotropic activity within 4 weeks prior to screening. (For Cohort 3, use of disopyramide is required).
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- Has any ECG abnormality considered by the investigator to pose a risk to patient safety (eg, second degree atrioventricular block type II).
- Paroxysmal atrial fibrillation or flutter documented during the screening period.
- Paroxysmal or permanent atrial fibrillation requiring rhythm restoring treatment (eg, direct-current cardioversion, ablation procedure, or antiarrhythmic therapy) ≤6 months prior to screening. (This exclusion does not apply if atrial fibrillation has been treated with anticoagulation and adequately rate-controlled for >6 months).
- History of syncope or sustained ventricular tachyarrhythmia with exercise within 6 months prior to screening.
- Has received prior treatment with CK-3773274 or mavacamten.
- For Cohort 4: has any documented history of LVOT-G ≥ 30 mmHg at rest, with Valsalva, or with exercise (for subjects who have had prior septal reduction therapy, this exclusion criteria only applies to gradients detected following septal reduction therapy).
Trial locations and contacts
22 sites in 4 countries.
22 sites in 4 countries
United States18 sites
Michigan Medicine - University of Michigan
Ann Arbor, Michigan, 48109
Tufts Medical Center
Boston, Massachusetts, 02111
Massachusetts General Hospital
Boston, Massachusetts, 02114
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Carolinas Medical Center
Charlotte, North Carolina, 28203
University of Virginia Health System
Charlottesville, Virginia, 22903
UT Southwestern Medical Center
Dallas, Texas, 75390
Duke Cardiology at Southpoint
Durham, North Carolina, 27713
Northwestern University
Evanston, Illinois, 60208
Houston Methodist Hospital
Houston, Texas, 77030
Cedar-Sinai Medical Center
Los Angeles, California, 90048
Intermountain Medical Center
Murray, Utah, 84107
New York University Langone Health Medical Center
New York, New York, 10016
Hospital of the University of Pennsylvania (University of Pennsylvania School of Medicine)
Philadelphia, Pennsylvania, 19104
UMPC Heart and Vascular Institute
Pittsburgh, Pennsylvania, 15213
Oregon Health and Science University
Portland, Oregon, 97239
UCSF Medical Center
San Francisco, California, 94143
Washington University School of Medicine
St Louis, Missouri, 63110
Spain2 sites
Complejo Hospitalario Universitario A Coruña
A Coruña, 15003
Hospital Universitario Puerta de Hierro de Majadahonda
Madrid
Netherlands1 site
Erasmus University Medical Center (Erasmus MC)
Rotterdam
About this study
Official title: A Multi-Center, Randomized, Double-blind, Placebo-controlled, Dose-finding Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CK-3773274 in Adults With Symptomatic Hypertrophic Cardiomyopathy
This study is being performed to understand the effect of different doses of CK-3773274 on patients with hypertrophic cardiomyopathy (HCM).
Read the detailed description
This was a Phase 2, multi-center, randomized, placebo-controlled, double-blind, dose-finding study in participants with symptomatic HCM. The study consisted of 4 cohorts. For Cohorts 1 and 2, participants with obstructive HCM (oHCM) and not receiving disopyramide were randomized 2:1 to active or placebo treatment and received up to 3 escalating doses of aficamten (5, 10, and 15 mg once daily in Cohort 1 and 10, 20, and 30 mg once daily in Cohort 2) or placebo based on site-read echocardiographic guidance. Cohort 3 consisted of participants with oHCM whose background HCM therapy included disopyramide. All participants in Cohort 3 received up to 3 escalating doses of aficamten (5, 10, and 15 mg once daily) based on echocardiographic guidance. Cohort 4 consisted of participants with non-obstructive HCM (nHCM) on standard of care background therapy. Cohort 4 participants received up to 3 doses of aficamten (5, 10, and 15 mg once daily), titrated based on site-read echocardiographic guidance.
In all 4 cohorts, treatment duration was 10 weeks with a 4-week follow-up period after the last dose.
- Conditions
- Hypertrophic Cardiomyopathy (HCM)
- Being tested
- CK-3773274 (5 - 15 mg), CK-3773274 (10 - 30 mg), Placebo for CK-3773274
- Keywords
- CK-3773274, CK-274, obstructive hypertrophic cardiomyopathy, oHCM, REDWOOD-HCM, non-obstructive hypertrophic cardiomyopathy, nHCM, hypertrophic cardiomyopathy, HCM, aficamten, CY 6021
- Medical subject headings
- Cardiomyopathy, Hypertrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CK-3773274 (5 - 15 mg)Drug
CK-3773274 tablets administered orally once daily
CK-3773274 (10 - 30 mg)Drug
CK-3773274 tablets administered orally once daily
Placebo for CK-3773274Drug
Placebo administered orally once daily
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 (oHCM) - Aficamten | Experimental | Participants received CK-3773274 doses of 5 - 15 mg once daily with dose levels guided by echocardiography assessments for up to 10 weeks Receives: Drug: CK-3773274 (5 - 15 mg) |
| Cohort 1 (oHCM) - Placebo | Placebo comparator | Participants received placebo once daily for up to 10 weeks Receives: Drug: Placebo for CK-3773274 |
| Cohort 2 (oHCM) - Aficamten | Experimental | Participants received CK-3773274 doses 10 - 30 mg once daily with dose levels guided by echocardiography assessments for up to 10 weeks Receives: Drug: CK-3773274 (10 - 30 mg) |
| Cohort 2 (oHCM) - Placebo | Placebo comparator | Participants received placebo once daily for up to 10 weeks Receives: Drug: Placebo for CK-3773274 |
| Cohort 3 (oHCM) - Aficamten & Background Disopyramide | Experimental | Participants received CK-3773274 doses 5 - 15 mg once daily with dose levels guided by echocardiography assessments for up to 10 weeks while taking disopyramide Receives: Drug: CK-3773274 (5 - 15 mg) |
| Cohort 4 (nHCM) - Aficamten | Experimental | Participants received CK-3773274 doses of 5 - 15 mg once daily with dose levels guided by echocardiography assessments for up to 10 weeks Receives: Drug: CK-3773274 (5 - 15 mg) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse Events (AEs)
Participant incidence of reported AEs to determine the safety and tolerability of aficamten in participants with HCM.
Measured: 14 weeks
Incidence of Left Ventricular Ejection Fraction (LVEF) < 50%
Participant incidence of LVEF < 50% as assessed by the core laboratory assessment.
Measured: 14 weeks
Incidence of Serious Adverse Events (SAEs)
Participant incidence of reported SAEs to determine the safety and tolerability of aficamten in participants with symptomatic HCM.
Measured: 14 weeks
Secondary outcomes (5)
Slope of the Relationship of the Plasma Concentration of CK-3773274 to the Change From Baseline in the Resting Left Ventricular Outflow Track Gradient (LVOT-G)
Concentration-response relationship of CK-3773274 on the resting LVOT-G on echocardiogram over 10 weeks of treatment in participants with (oHCM) obstructive hypertrophic cardiomyopathy (oHCM) (Cohorts 1, 2, 3 only)
Measured: Baseline and 10 weeks
Slope of the Relationship of the Plasma Concentration of CK-3773274 to the Change From Baseline in the Post-Valsalva LVOT-G
Concentration-response relationship of CK-3773274 on the post-Valsalva LVOT-G on echocardiogram over 10 weeks of treatment in participants with oHCM (Cohorts 1, 2, 3 only)
Measured: Baseline and 10 Weeks
Change From Baseline in Resting LVOT-G Over Time as a Function of Dose.
Dose response relationship on resting LVOT-G of CK-3773274 in participants with oHCM (Cohorts 1, 2, 3 only)
Measured: Baseline and 10 Weeks
Change From Baseline in Post-Valsalva LVOT-G Over Time as a Function of Dose.
Dose response relationship of CK-3773274 on post-Valsalva LVOT-G in participants with symptomatic oHCM (Cohorts 1, 2, 3 only)
Measured: 10 weeks
Slope of the Relationship of the Plasma Concentration of CK-3773274 to the Change From Baseline in the Resting LVEF
Concentration-response relationship of CK-3773274 on LVEF over 10 weeks of treatment in participants with HCM
Measured: Day 1 to End of Study (EOS) (Week 14)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2020
- Study start10 Jan 2020
- Primary completion28 Feb 2023
- Study completion28 Feb 2023
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.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hypertrophic Cardiomyopathy (HCM)Studies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cytokinetics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Cytokinetics, MD, Study director, Cytokinetics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04219826
- Sponsor's protocol ID
- CY 6021
- Other IDs
- 2019-002785-12, 2019
- Acronym
- REDWOOD-HCM
- Status last verified
- Dec 2025
- First submitted
- 3 Jan 2020
- Last updated
- 24 Feb 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Masri A, Sherrid MV, Abraham TP, Choudhury L, Garcia-Pavia P, Kramer CM, Barriales-Villa R, Owens AT, Rader F, Nagueh SF, Olivotto I, Saberi S, Tower-Rader A, Wong TC, Coats CJ, Watkins H, Fifer MA, Solomon SD, Heitner SB, Jacoby DL, Kupfer S, Malik FI, Meng L, Sohn RL, Wohltman A, Maron MS; REDWOOD-HCM Investigators. Efficacy and Safety of Aficamten in Symptomatic Nonobstructive Hypertrophic Cardiomyopathy: Results From the REDWOOD-HCM Trial, Cohort 4. J Card Fail. 2024 Nov;30(11):1439-1448. doi: 10.1016/j.cardfail.2024.02.020. Epub 2024 Mar 15.
PubMed 38493832Zampieri M, Argiro A, Marchi A, Berteotti M, Targetti M, Fornaro A, Tomberli A, Stefano P, Marchionni N, Olivotto I. Mavacamten, a Novel Therapeutic Strategy for Obstructive Hypertrophic Cardiomyopathy. Curr Cardiol Rep. 2021 Jun 3;23(7):79. doi: 10.1007/s11886-021-01508-0.
PubMed 34081217
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Randomized, Double-blind, Placebo-controlled, Dose-finding Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CK-3773274 in Adults With Symptomatic Hypertrophic Cardiomyopathy
- ClinicalTrials.gov ID
- NCT04219826
- Acronym / sponsor ID
- REDWOOD-HCM / CY 6021
- Conditions
- Hypertrophic Cardiomyopathy (HCM)
- Keywords
- CK-3773274, CK-274, obstructive hypertrophic cardiomyopathy, oHCM, REDWOOD-HCM, non-obstructive hypertrophic cardiomyopathy, nHCM, hypertrophic cardiomyopathy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- CytokineticsIndustry (pharma, biotech, devices)
- Study start
- 10 Jan 2020 (actual)
- Primary completion
- 28 Feb 2023 (actual)
- Study completion
- 28 Feb 2023 (actual)
- First posted
- 7 Jan 2020 (actual)
- Results
- Posted 24 Feb 2026
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 being performed to understand the effect of different doses of CK-3773274 on patients with hypertrophic cardiomyopathy (HCM).
Detailed description
This was a Phase 2, multi-center, randomized, placebo-controlled, double-blind, dose-finding study in participants with symptomatic HCM. The study consisted of 4 cohorts. For Cohorts 1 and 2, participants with obstructive HCM (oHCM) and not receiving disopyramide were randomized 2:1 to active or placebo treatment and received up to 3 escalating doses of aficamten (5, 10, and 15 mg once daily in Cohort 1 and 10, 20, and 30 mg once daily in Cohort 2) or placebo based on site-read echocardiographic guidance. Cohort 3 consisted of participants with oHCM whose background HCM therapy included disopyramide. All participants in Cohort 3 received up to 3 escalating doses of aficamten (5, 10, and 15 mg once daily) based on echocardiographic guidance. Cohort 4 consisted of participants with non-obstructive HCM (nHCM) on standard of care background therapy. Cohort 4 participants received up to 3 doses of aficamten (5, 10, and 15 mg once daily), titrated based on site-read echocardiographic guidance.
In all 4 cohorts, treatment duration was 10 weeks with a 4-week follow-up period after the last dose.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 (oHCM) - Aficamten | Experimental | Drug: CK-3773274 (5 - 15 mg)Participants received CK-3773274 doses of 5 - 15 mg once daily with dose levels guided by echocardiography assessments for up to 10 weeks |
| Cohort 1 (oHCM) - Placebo | Placebo comparator | Drug: Placebo for CK-3773274Participants received placebo once daily for up to 10 weeks |
| Cohort 2 (oHCM) - Aficamten | Experimental | Drug: CK-3773274 (10 - 30 mg)Participants received CK-3773274 doses 10 - 30 mg once daily with dose levels guided by echocardiography assessments for up to 10 weeks |
| Cohort 2 (oHCM) - Placebo | Placebo comparator | Drug: Placebo for CK-3773274Participants received placebo once daily for up to 10 weeks |
| Cohort 3 (oHCM) - Aficamten & Background Disopyramide | Experimental | Drug: CK-3773274 (5 - 15 mg)Participants received CK-3773274 doses 5 - 15 mg once daily with dose levels guided by echocardiography assessments for up to 10 weeks while taking disopyramide |
| Cohort 4 (nHCM) - Aficamten | Experimental | Drug: CK-3773274 (5 - 15 mg)Participants received CK-3773274 doses of 5 - 15 mg once daily with dose levels guided by echocardiography assessments for up to 10 weeks |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Males and females between 18 and 85 years of age at screening.
- Body weight is ≥45 kg at screening.
- Diagnosed with HCM per the following criteria:
- Adequate acoustic windows for echocardiography.
- For Cohorts 1, 2 and 3 has LVOT-G during screening as follows:
Key exclusion criteria (12 listed)
- Aortic stenosis or fixed subaortic obstruction.
- Known infiltrative or storage disorder causing cardiac hypertrophy that mimics oHCM (eg, Noonan syndrome, Fabry disease, amyloidosis).
- History of LV systolic dysfunction (LVEF <45%) at any time during their clinical course.
- Documented history of current obstructive coronary artery disease (>70% stenosis in one or more epicardial coronary arteries) or documented history of myocardial infarction.
- Has been treated with septal reduction therapy (surgical myectomy or percutaneous alcohol septal ablation) or has plans for either treatment during the study period (Cohorts 1, 2, and 3 only). Patients having undergone septal reduction therapy > 12 months prior to screening who remain symptomatic from nHCM, and who meet all other criteria for inclusion, may be enrolled in Cohort 4.
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 |
|---|---|---|
| CK-3773274 (5 - 15 mg)CK-3773274 tablets administered orally once daily | Drug | Cohort 1 (oHCM) - Aficamten, Cohort 3 (oHCM) - Aficamten & Background Disopyramide, Cohort 4 (nHCM) - Aficamten |
| CK-3773274 (10 - 30 mg)CK-3773274 tablets administered orally once daily | Drug | Cohort 2 (oHCM) - Aficamten |
| Placebo for CK-3773274Placebo administered orally once daily | Drug | Cohort 1 (oHCM) - Placebo, Cohort 2 (oHCM) - Placebo |
Primary outcome
Incidence of Adverse Events (AEs)
Time frame: 14 weeks
Participant incidence of reported AEs to determine the safety and tolerability of aficamten in participants with HCM.
Incidence of Left Ventricular Ejection Fraction (LVEF) < 50%
Time frame: 14 weeks
Participant incidence of LVEF < 50% as assessed by the core laboratory assessment.
Incidence of Serious Adverse Events (SAEs)
Time frame: 14 weeks
Participant incidence of reported SAEs to determine the safety and tolerability of aficamten in participants with symptomatic HCM.
5 secondary outcomes
Slope of the Relationship of the Plasma Concentration of CK-3773274 to the Change From Baseline in the Resting Left Ventricular Outflow Track Gradient (LVOT-G)
Time frame: Baseline and 10 weeks
Slope of the Relationship of the Plasma Concentration of CK-3773274 to the Change From Baseline in the Post-Valsalva LVOT-G
Time frame: Baseline and 10 Weeks
Change From Baseline in Resting LVOT-G Over Time as a Function of Dose.
Time frame: Baseline and 10 Weeks
Change From Baseline in Post-Valsalva LVOT-G Over Time as a Function of Dose.
Time frame: 10 weeks
Slope of the Relationship of the Plasma Concentration of CK-3773274 to the Change From Baseline in the Resting LVEF
Time frame: Day 1 to End of Study (EOS) (Week 14)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38493832Masri A, Sherrid MV, Abraham TP, Choudhury L, Garcia-Pavia P, Kramer CM, Barriales-Villa R, Owens AT, Rader F, Nagueh SF, Olivotto I, Saberi S, Tower-Rader A, Wong TC, Coats CJ, Watkins H, Fifer MA, Solomon SD, Heitner SB, Jacoby DL, Kupfer S, Malik FI, Meng L, Sohn RL, Wohltman A, Maron MS; REDWOOD-HCM Investigators. Efficacy and Safety of Aficamten in Symptomatic Nonobstructive Hypertrophic Cardiomyopathy: Results From the REDWOOD-HCM Trial, Cohort 4. J Card Fail. 2024 Nov;30(11):1439-1448. doi: 10.1016/j.cardfail.2024.02.020. Epub 2024 Mar 15.
- Derived from this study: PubMed 34081217Zampieri M, Argiro A, Marchi A, Berteotti M, Targetti M, Fornaro A, Tomberli A, Stefano P, Marchionni N, Olivotto I. Mavacamten, a Novel Therapeutic Strategy for Obstructive Hypertrophic Cardiomyopathy. Curr Cardiol Rep. 2021 Jun 3;23(7):79. doi: 10.1007/s11886-021-01508-0.
- 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.
Cytokinetics, MD study director
Cytokinetics
22 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CK-3773274 (5 - 15 mg) and CK-3773274 (10 - 30 mg) in people with Hypertrophic Cardiomyopathy (HCM), run by Cytokinetics at 22 sites in 4 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 15 inclusion and 12 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 24 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in United States, Spain, Italy, Netherlands. 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 24 Feb 2026). 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?
Incidence of Adverse Events (AEs) (time frame: 14 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04219826, which also lists 2 linked publications.
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 24 Feb 2026; AzTrials last refreshed its copy on 30 Oct 2026.