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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04089566

Registration number

NCT04089566

Ethics application status

Date submitted

11/09/2019

Date registered

13/09/2019

Titles & IDs

Public title

Study of Nusinersen (BIIB058) in Participants With Spinal Muscular Atrophy

Scientific title

Escalating Dose and Randomized, Controlled Study of Nusinersen (BIIB058) in Participants With Spinal Muscular Atrophy

Secondary ID [1]

2019-002663-10

Secondary ID [2]

232SM203

Universal Trial Number (UTN)

Trial acronym

DEVOTE

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Muscular Atrophy, Spinal

Condition category

Condition code

Musculoskeletal

Other muscular and skeletal disorders

Neurological

Other neurological disorders

Other

Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Treatment: Drugs - Nusinersen

Experimental: 28/28 Milligram (mg) Safety Group - Part A: Participants with later-onset SMA will receive loading doses of 28 mg of nusinersen intrathecally on Days 1, 15 and 29 followed by maintenance doses of 28 mg on Days 149 and 269.

Active comparator: 12/12 mg Active Control Group - Part B: Participants with infantile- or later-onset SMA will receive loading doses of 12 mg of nusinersen intrathecally on Days 1, 15, 29, and 64 followed by maintenance doses of 12 mg on Days 183 and 279. Sham procedure will be administered on Day 135.

Experimental: 50/28 mg Active Treatment Group - Part B: Participants with infantile- or later-onset SMA will receive loading doses of 50 mg of nusinersen intrathecally on Days 1 and 15 followed by maintenance doses of 28 mg on Days 135 and 279. Sham procedure will be administered on Days 29, 64 and 183.

Experimental: 12/50/28 mg Titration Group - Part C: Participants who have been receiving the approved dose of 12 mg for at least 1 year prior to entry, will receive a single bolus dose of 50 mg of nusinersen intrathecally on Day 1 (4 months after their most recent maintenance dose of 12 mg) followed by maintenance doses of 28 mg on Days 121 and 241.

Treatment: Drugs: Nusinersen
Administered as specified in the treatment arm

Intervention code [1]

Treatment: Drugs

Comparator / control treatment

Control group

Outcomes

Primary outcome [1]

Part B Infantile-onset SMA: Change from Baseline in CHOP-INTEND Total Score for Nusinersen 50/28mg Treatment Group Versus CS3B Matched Sham Control Group

Timepoint [1]

Baseline up to Day 183

Primary outcome [2]

Part A and C: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)

Timepoint [2]

Screening up to Day 389

Primary outcome [3]

Part A and C: Number of Participants with Clinically Significant Shifts from Baseline in Clinical Laboratory Parameters

Timepoint [3]

Screening up to Day 302

Primary outcome [4]

Part A and C: Number of Participants with Clinically Significant Shifts from Baseline in Electrocardiograms (ECGs)

Timepoint [4]

Screening up to Day 302

Primary outcome [5]

Part A and C: Number of Participants with Clinically Significant Shifts from Baseline in Vital Signs

Timepoint [5]

Screening up to Day 302

Primary outcome [6]

Part A and C: Change from Baseline in Body Length/Height

Timepoint [6]

Baseline up to Day 302

Primary outcome [7]

Part C Infantile-onset SMA: Change from Baseline in Head Circumference

Timepoint [7]

Baseline up to Day 302

Primary outcome [8]

Part C Infantile-onset SMA: Change from Baseline in Chest Circumference

Timepoint [8]

Baseline up to Day 302

Primary outcome [9]

Part C Infantile-onset SMA: Change from Baseline in Arm Circumference

Timepoint [9]

Baseline up to Day 302

Primary outcome [10]

Part A and C Later-onset SMA: Change from Baseline in Ulnar Length

Timepoint [10]

Baseline up to Day 302

Primary outcome [11]

Part A and C: Ratio of Weight for Age

Timepoint [11]

Baseline up to Day 302

Primary outcome [12]

Part A and C: Ratio of Weight for Length

Timepoint [12]

Baseline up to Day 302

Primary outcome [13]

Part C: Ratio of Head-to-chest Circumference

Timepoint [13]

Baseline up to Day 302

Primary outcome [14]

Part A and C: Change from Baseline in Activated Partial Thromboplastin Time (aPTT)

Timepoint [14]

Baseline up to Day 269

Primary outcome [15]

Part A and C: Change from Baseline in Prothrombin Time (PT)

Timepoint [15]

Baseline up to Day 269

Primary outcome [16]

Part A and C: Change from Baseline in International Normalized Ratio (INR)

Timepoint [16]

Baseline up to Day 269

Primary outcome [17]

Part A and C: Change in Urine Total Protein

Timepoint [17]

Baseline up to Day 302

Primary outcome [18]

Part A and C: Change from Baseline in Neurological Examination Outcomes

Timepoint [18]

Baseline up to Day 302

Primary outcome [19]

Part A and C: Percentage of Participants with a Postbaseline Platelet Count Below the Lower Limit of Normal on at least 2 Consecutive Measurements

Timepoint [19]

Baseline up to Day 302

Primary outcome [20]

Part A and C: Percentage of Participants with a Postbaseline Corrected QT Interval Using Fridericia's Formula (QTcF) of > 500 millisecond (msec) and an Increase from Baseline to Any Postbaseline Timepoint in QTcF of > 60 msec

Timepoint [20]

Baseline up to Day 302

Secondary outcome [1]

Part B Infantile-onset SMA: Percentage of Hammersmith Infant Neurological Examination (HINE) Section 2 Motor Milestone Responders for Nusinersen 50/28mg Treatment Group Versus CS3B Matched Sham Control Group

Timepoint [1]

Baseline up to Day 183

Secondary outcome [2]

Part B Infantile-onset SMA: Change from Baseline in HINE Section 2 Motor Milestones Total Score for Nusinersen 50/28mg Treatment Group Versus CS3B Matched Sham Control Group

Timepoint [2]

Baseline up to Day 183

Secondary outcome [3]

Part B Infantile-onset SMA: Change from Baseline in Plasma Concentration of Neurofilament Light Chain (NF-L) for Nusinersen 50/28mg Treatment Group Versus CS3B Matched Sham Control Group

Timepoint [3]

Baseline up to Day 183

Secondary outcome [4]

Part B Infantile-onset SMA: Change from Baseline in CHOP-INTEND Total Score for Nusinersen 50/28mg Treatment Group Versus 12/12mg Active Control Group

Timepoint [4]

Baseline up to Day 302

Secondary outcome [5]

Part B Infantile-onset SMA: Change from Baseline in HINE Section 2 Motor Milestones Total Score for Nusinersen 50/28mg Treatment Group Versus 12/12mg Active Control Group

Timepoint [5]

Baseline up to Day 302

Secondary outcome [6]

Part B Infantile-onset SMA: Change from Baseline in Plasma Concentration of NF-L for Nusinersen 50/28mg Treatment Group Versus 12/12mg Active Control Group

Timepoint [6]

Baseline up to Day 29

Secondary outcome [7]

Part B Infantile-onset SMA: Time to Death or Permanent Ventilation for Nusinersen 50/28mg Treatment Group Versus CS3B Matched Sham Control Group

Timepoint [7]

Screening up to Day 183

Secondary outcome [8]

Part B Infantile-onset SMA: Time to Death (Overall Survival) for Nusinersen 50/28mg Treatment Group Versus CS3B Matched Sham Control Group

Timepoint [8]

Screening up to Day 183

Secondary outcome [9]

Part B Infantile-onset SMA: Time to Death or Permanent Ventilation for Nusinersen 50/28mg Treatment Group Versus 12/12mg Active Control Group

Timepoint [9]

Screening up to Day 399

Secondary outcome [10]

Part B Infantile-onset SMA: Time to Death (Overall Survival) for Nusinersen 50/28mg Treatment Group Versus 12/12mg Active Control Group

Timepoint [10]

Screening up to Day 399

Secondary outcome [11]

Part B Later-onset SMA: Change from Baseline in Hammersmith Functional Motor Scale Expanded (HFMSE) Score for Nusinersen 50/28mg Treatment Group Versus 12/12mg Active Control Group

Timepoint [11]

Baseline up to Day 302

Secondary outcome [12]

Part B Later-onset SMA: Change from Baseline in Revised Upper Limb Module (RULM) Score for Nusinersen 50/28mg Treatment Group Versus 12/12mg Active Control Group

Timepoint [12]

Baseline up to Day 302

Secondary outcome [13]

Part B Later-onset SMA: Total Number of New World Health Organization (WHO) Motor Milestones for Nusinersen 50/28mg Treatment Group Versus 12/12mg Active Control Group

Timepoint [13]

Baseline up to Day 302

Secondary outcome [14]

Part B Later-onset SMA: Change from Baseline in Assessment of Caregiver Experience with Neuromuscular Disease (ACEND) for Nusinersen 50/28mg Treatment Group Versus 12/12mg Active Control Group

Timepoint [14]

Baseline up to Day 302

Secondary outcome [15]

Part B Later-onset SMA: Change from Baseline in Pediatric Quality of Life Inventory™ (PedsQL) for Nusinersen 50/28mg Treatment Group Versus 12/12mg Active Control Group

Timepoint [15]

Baseline up to Day 302

Secondary outcome [16]

Part B Later-onset SMA: Change from Baseline in Cerebral Spinal Fluid (CSF) Concentration of NF-L for Nusinersen 50/28mg Treatment Group Versus 12/12mg Active Control Group

Timepoint [16]

Baseline up to Day 302

Secondary outcome [17]

Part B Later-onset SMA: Change from Baseline in Plasma Concentration of NF-L for Nusinersen 50/28mg Treatment Group Versus 12/12mg Active Control Group

Timepoint [17]

Baseline up to Day 302

Secondary outcome [18]

Part B: Number of Participants with AEs and SAEs

Timepoint [18]

Screening up to Day 399

Secondary outcome [19]

Part B: Number of Participants with Clinically Significant Shifts from Baseline in Clinical Laboratory Parameters

Timepoint [19]

Screening up to Day 302

Secondary outcome [20]

Part B: Number of Participants with Clinically Significant Shifts from Baseline in ECGs

Timepoint [20]

Day 1 up to Day 302

Secondary outcome [21]

Part B: Number of Participants with Clinically Significant Shifts from Baseline in Vital Signs

Timepoint [21]

Screening up to Day 302

Secondary outcome [22]

Part B: Change from Baseline in Body Length/Height

Timepoint [22]

Baseline up to Day 302

Secondary outcome [23]

Part B Infantile-onset SMA: Change from Baseline in Head Circumference

Timepoint [23]

Baseline up to Day 302

Secondary outcome [24]

Part B Infantile-onset SMA: Change from Baseline in Chest Circumference

Timepoint [24]

Baseline up to Day 302

Secondary outcome [25]

Part B Infantile-onset SMA: Change from Baseline in Arm Circumference

Timepoint [25]

Baseline up to Day 302

Secondary outcome [26]

Part B Later-onset SMA: Change from Baseline in Ulnar Length

Timepoint [26]

Baseline up to Day 302

Secondary outcome [27]

Part B: Ratio of Weight for Age

Timepoint [27]

Baseline up to Day 302

Secondary outcome [28]

Part B: Ratio of Weight for Length

Timepoint [28]

Baseline up to Day 302

Secondary outcome [29]

Part B: Ratio of Head-to-chest Circumference

Timepoint [29]

Baseline up to Day 302

Secondary outcome [30]

Part B: Change from Baseline in aPTT

Timepoint [30]

Baseline up to Day 279

Secondary outcome [31]

Part B: Change from Baseline in PT

Timepoint [31]

Baseline up to Day 279

Secondary outcome [32]

Part B: Change from Baseline in INR

Timepoint [32]

Baseline up to Day 279

Secondary outcome [33]

Part B: Change in Urine Total Protein

Timepoint [33]

Baseline up to Day 302

Secondary outcome [34]

Part B: Change from Baseline in Neurological Examination Outcomes

Timepoint [34]

Baseline up to Day 302

Secondary outcome [35]

Part B: Percentage of Participants with a Postbaseline Platelet Count Below the Lower Limit of Normal on at least 2 Consecutive Measurements

Timepoint [35]

Baseline up to Day 302

Secondary outcome [36]

Part B: Percentage of Participants with a Postbaseline QTcF of > 500 msec and an Increase from Baseline to Any Postbaseline Timepoint in QTcF of > 60 msec

Timepoint [36]

Baseline up to Day 302

Secondary outcome [37]

Part A, B and C: Number of Hospitalizations

Timepoint [37]

Day 1 to Day 302

Secondary outcome [38]

Part A, B and C: Duration of Hospitalizations

Timepoint [38]

Day 1 to Day 302

Secondary outcome [39]

Part A, B and C: Clinical Global Impression of Change (CGIC)

Timepoint [39]

Day 302

Secondary outcome [40]

Part A, B and C: Number of Participants with Serious Respiratory Events

Timepoint [40]

Screening up to Day 399

Secondary outcome [41]

Part B Infantile-onset SMA: Percentage of Time on Ventilation

Timepoint [41]

Screening up to Day 302

Secondary outcome [42]

Parts A, B and C: Ventilator Use

Timepoint [42]

Screening up to Day 302

Secondary outcome [43]

Parts A and B: Change from Baseline in the Parent Assessment of Swallowing Ability (PASA) Scale

Timepoint [43]

Baseline up to Day 302

Secondary outcome [44]

Part B: Infantile SMA-onset: Change from baseline in CSF concentration of NF-L

Timepoint [44]

Baseline up to Day 302

Secondary outcome [45]

Part A and C: Change from Baseline in HFMSE Score

Timepoint [45]

Baseline up to Day 302

Secondary outcome [46]

Part A and C: Change from Baseline in RULM Score

Timepoint [46]

Baseline up to Day 302

Secondary outcome [47]

Part A and C: Total Number of New WHO Motor Milestones

Timepoint [47]

Baseline up to Day 302

Secondary outcome [48]

Part A and C: Change from Baseline in ACEND

Timepoint [48]

Baseline up to Day 302

Secondary outcome [49]

Part A and C: Change from Baseline in PedsQL™

Timepoint [49]

Baseline up to Day 302

Secondary outcome [50]

Part C: Change from Baseline in CHOP-INTEND Total Score

Timepoint [50]

Baseline to up Day 302

Secondary outcome [51]

Part C: Change from Baseline in HINE Section 2 Motor Milestones Total Score

Timepoint [51]

Baseline up to Day 302

Eligibility

Key inclusion criteria

Key

Part A, B and C:

- Genetic documentation of 5q SMA (homozygous gene deletion, mutation, or compound heterozygote)

Part A:

* Onset of clinical signs and symptoms consistent with SMA at > 6 months (> 180 days) of age (i.e., later-onset SMA)
* Age 2 to = 15 years, inclusive, at the time of informed consent

Part B:

* Participants with SMA symptom onset = 6 months (= 180 days) of age (infantile onset) should have age > 1 week to = 7 months (= 210 days) at the time of informed consent
* Participants with SMA symptom onset > 6 months (> 180 days) of age (later onset):

* Age 2 to < 10 years at the time of informed consent
* Can sit independently but has never had the ability to walk independently
* HFMSE score = 10 and = 54 at Screening

Part C:

- Currently on nusinersen treatment at the time of Screening, with the first dose being at least 1 year prior to Screening

Part C Cohort 1:

- Participants of any age (individuals =18 years of age at Screening must be ambulatory)

Part C Cohort 2:

* Participants =18 years of age at Screening (can be ambulatory or nonambulatory)
* HFMSE total score =4 points at Screening
* RULM entry item A score =3 points at Screening

Key

Minimum age

7 Days

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Part A, B and C:

* Presence of an untreated or inadequately treated active infection requiring systemic antiviral or antimicrobial therapy at any time during the Screening period
* Presence of an implanted shunt for the drainage of cerebrospinal fluid (CSF) or of an implanted central nervous system (CNS) catheter
* Hospitalization for surgery, pulmonary event, or nutritional support within 2 months prior to Screening or planned within 12 months after the participant's first dose

Part A:

* Respiratory insufficiency, defined by the medical necessity for invasive or noninvasive ventilation for > 6 hours during a 24-hour period, at Screening
* Medical necessity for a gastric feeding tube
* Treatment with an investigational drug given for the treatment of SMA, biological agent, or device within 30 days or 5 half-lives of the agent, whichever is longer, prior to Screening or anytime during the study; any prior or current treatment with any survival motor neuron-2 gene (SMN2)-splicing modifier or gene therapy; or prior antisense oligonucleotide treatment, or cell transplantation

Part B:

* Treatment with an investigational drug including but not limited to the treatment of SMA, biological agent, or device within 30 days or 5 half-lives of the agent, whichever is longer, prior to Screening or anytime during the study; any prior or current treatment with any SMN2-splicing modifier or gene therapy; or prior antisense oligonucleotide treatment, or cell transplantation
* Participants with SMA symptom onset > 6 months (> 180 days) of age (later onset):

* Respiratory insufficiency, defined by the medical necessity for invasive or noninvasive ventilation for > 6 hours during a 24-hour period, at Screening
* Medical necessity for a gastric feeding tube
* Participants with SMA symptom onset = 6 months (= 180 days) of age (infantile onset): Signs or symptoms of SMA present at birth or within the first week after birth

Part C:

* Concurrent or previous participation and/or administration of nusinersen in another clinical study
* Concomitant or previous administration of any SMN2-splicing modifier (excluding nusinersen) or gene therapy, either in a clinical study or as part of medical care.
* Concurrent or previous participation in any interventional investigational study for any other drug or device within 30 days or 5 half-lives of the agent, whichever is longer, prior to Screening

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment

Other

Other design features

Phase

Phase 3

Type of endpoint/s

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Data analysis

Reason for early stopping/withdrawal

Other reasons

Date of first participant enrolment

Anticipated

Actual

26/03/2020

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

30/05/2024

Sample size

Target

Accrual to date

Final

145

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

Royal Children's Hospital - Parkville

Recruitment postcode(s) [1]

3052 - Parkville

Recruitment outside Australia

Country [1]

United States of America

State/province [1]

California

Country [2]

United States of America

State/province [2]

Colorado

Country [3]

United States of America

State/province [3]

Illinois

Country [4]

United States of America

State/province [4]

Maryland

Country [5]

United States of America

State/province [5]

Massachusetts

Country [6]

United States of America

State/province [6]

Tennessee

Country [7]

United States of America

State/province [7]

Texas

Country [8]

Brazil

State/province [8]

Minas Gerais

Country [9]

Brazil

State/province [9]

Rio Grande Do Sul

Country [10]

Brazil

State/province [10]

Sao Paulo

Country [11]

Canada

State/province [11]

British Columbia

Country [12]

Canada

State/province [12]

Ontario

Country [13]

Canada

State/province [13]

Quebec

Country [14]

Chile

State/province [14]

Santiago

Country [15]

China

State/province [15]

Beijing

Country [16]

China

State/province [16]

Chongqing

Country [17]

China

State/province [17]

Guangzhou

Country [18]

China

State/province [18]

Hunan

Country [19]

China

State/province [19]

Shandong

Country [20]

China

State/province [20]

Sichuan

Country [21]

Colombia

State/province [21]

Bogota

Country [22]

Colombia

State/province [22]

Medellin

Country [23]

Estonia

State/province [23]

Tallinn

Country [24]

France

State/province [24]

Haute Garonne

Country [25]

France

State/province [25]

Hauts De Seine

Country [26]

Germany

State/province [26]

Baden Wuerttemberg

Country [27]

Germany

State/province [27]

Hessen

Country [28]

Greece

State/province [28]

Athens

Country [29]

Greece

State/province [29]

Thessaloniki

Country [30]

Hungary

State/province [30]

Budapest

Country [31]

Ireland

State/province [31]

Dublin

Country [32]

Israel

State/province [32]

Petach-Tikva

Country [33]

Israel

State/province [33]

Tel Aviv

Country [34]

Italy

State/province [34]

Milano

Country [35]

Italy

State/province [35]

Roma

Country [36]

Japan

State/province [36]

Fukuoka-Ken

Country [37]

Japan

State/province [37]

Hyogo-Ken

Country [38]

Japan

State/province [38]

Tokyo-To

Country [39]

Korea, Republic of

State/province [39]

Gyeongsangbuk-do

Country [40]

Korea, Republic of

State/province [40]

Seoul

Country [41]

Latvia

State/province [41]

Riga

Country [42]

Lebanon

State/province [42]

Beirut

Country [43]

Mexico

State/province [43]

Distrito Federal

Country [44]

Mexico

State/province [44]

Jalisco

Country [45]

Netherlands

State/province [45]

Utrecht

Country [46]

Poland

State/province [46]

Gdansk

Country [47]

Poland

State/province [47]

Warszawa

Country [48]

Russian Federation

State/province [48]

Ekaterinburg

Country [49]

Russian Federation

State/province [49]

Moskva

Country [50]

Saudi Arabia

State/province [50]

Dammam

Country [51]

Saudi Arabia

State/province [51]

Jeddah

Country [52]

Saudi Arabia

State/province [52]

Riyadh

Country [53]

Spain

State/province [53]

Barcelona

Country [54]

Spain

State/province [54]

Madrid

Country [55]

Spain

State/province [55]

Valencia

Country [56]

Taiwan

State/province [56]

Kaohsiung

Country [57]

Taiwan

State/province [57]

Taipei

Country [58]

Turkey

State/province [58]

Antalya

Country [59]

United Kingdom

State/province [59]

Greater London

Funding & Sponsors

Primary sponsor type

Commercial sector/industry

Name

Biogen

Address

Country

Ethics approval

Ethics application status

Summary

Brief summary

The primary objectives of this study are to examine the clinical efficacy of nusinersen administered intrathecally at higher doses to participants with spinal muscular atrophy (SMA), as measured by change in Children's Hospital of Philadelphia-Infant Test of Neuromuscular Disorders (CHOP-INTEND) total score (Part B); to examine the safety and tolerability of nusinersen administered intrathecally at higher doses to participants with SMA (Parts A and C).

The secondary objectives of this study are to examine the clinical efficacy of nusinersen administered intrathecally at higher doses to participants with SMA (Parts A, B and C); to examine the effect of nusinersen administered intrathecally at higher doses to participants with SMA (Parts A and C); to examine the safety and tolerability of nusinersen administered intrathecally at higher doses to participants with SMA, to examine the effect of nusinersen administered intrathecally at higher doses compared to the currently approved dose in participants with SMA (Part B).

Trial website

https://clinicaltrials.gov/study/NCT04089566

Trial related presentations / publications

Finkel RS, Ryan MM, Pascual Pascual SI, Day JW, Mercuri E, De Vivo DC, Foster R, Montes J, Gurgel-Giannetti J, MacCannell D, Berger Z. Scientific rationale for a higher dose of nusinersen. Ann Clin Transl Neurol. 2022 Jun;9(6):819-829. doi: 10.1002/acn3.51562. Epub 2022 May 13.

Public notes

Contacts

Principal investigator

Name

Medical Director

Address

Biogen

Country

Phone

Fax

Contact person for public queries

Name

Address

Country

Phone

Fax

Contact person for scientific queries

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

Yes

What data in particular will be shared?

In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/

When will data be available (start and end dates)?

Available to whom?

Available for what types of analyses?

How or where can data be obtained?

IPD available at link: https://vivli.org/

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT04089566

Register a trial

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For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04089566