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CompletedNCT05870865Updated May 16, 2025Results posted

A Study to Evaluate the Anti-pruritic Effectiveness of ASN008 in Adults With Mild to Moderate Atopic Dermatitis

A Phase 2 interventional study of ASN008 and ASN008 Matching Vehicle in Dermatitis, Atopic and Pruritus, sponsored by TrialSpark. Completed at 27 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-16.

Sponsored by TrialSpark · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
144
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The goal of this clinical trial is to evaluate ASN008 in people with itch caused by eczema. The main questions it aims to answer are:

  • What is the efficacy and safety of ASN008?
  • What is the impact of ASN008 on itch in patients with atopic dermatitis? Participants will be asked to apply topical ASN008, or matching vehicle (placebo containing no active drug), to their eczema lesions twice daily for 4 weeks.

Researchers will compare 3 different doses of ASN008 and a matching vehicle group to see which group responds best.

Read the detailed description

All participants will sign an informed consent form and undergo screening (within 28 days prior to Day 1). During the screening period, all treatments for Atopic Dermatitis (AD) (also known as eczema) and/or itch will be stopped to allow for wash out, as applicable and according to eligibility requirements. Consistent daily or twice daily use of a non-prescription emollient is required at least 7 days prior to Day 1 and throughout the trial until the follow-up (Week 8). No other products, including, but not limited to, topical corticosteroids, calcineurin inhibitors, biologics, or Janus Kinase (JAK) inhibitors (topical or oral) may be used during the trial.

Eligible participants will be randomized in a 1:1:1:1 ratio to receive ASN008 gel 1.25 percent, ASN008 gel 2.5 percent, ASN008 gel 5.0 percent, or matching vehicle twice daily for 4 weeks (28 days), followed by a 4-week (28-day) follow-up period. The first dose of study treatment will be applied on Day 1 and the last dose will be applied on the morning of Day 28.

Participants will be required to participate in 8 scheduled visits: Screening; Randomization (remote visit); Day 1; Week 1 (Day 8); Week 2 (Day 15); Week 3 (Day 22); Week 4 (Day 28); and Week 8 (Day 56)/early termination (ET).

The trial duration per participant is up to 12 weeks (84 days): including up to 4 weeks (28 days) for the screening period, 4 weeks (28 days) for the treatment period, and up to 4 weeks (28 days) for the follow-up period.

A participant is considered to have reached the end of the trial when they have completed their Day 56 (Week 8) or ET visit. The trial will be considered complete when the last participant has completed their last trial visit.

02

Conditions studied

  • Dermatitis, Atopic
  • Pruritus

Keywords

  • Dermatitis, Atopic
  • Pruritus
  • Eczema
  • Itch
03

In context

Dermatitis, Atopic

1,419 studies on the registry are indexed under Dermatitis, Atopic; 258 are open to participants now.

This study's enrollment of 144 is above the median of 83 across 1,125 interventional studies indexed under Dermatitis, Atopic.

Browse Dermatitis, Atopic studies →

Lead sponsor

This is the only study on the registry with TrialSpark as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Male or female participants, 18 years or older, at the time of informed consent.
  • Diagnosis of mild to moderate AD for at least 12 months with no significant disease flares for at least 4 weeks before Screening (based upon medical chart, treating physician, or participant report with documented clinical confirmation by the Investigator)
  • Validated Investigator Global Assessment (vIGA) score of 2 or 3 at Day 1.
  • Body surface area (BSA) affected by AD ≤20% at Day 1.
  • Peak Pruritus NRS ≥7 at Day 1.
  • Body mass index (BMI) ≤40 kg/m2 at Screening.
  • Willingness to avoid pregnancy or fathering children.
  • Participant is willing to participate for the duration of the trial, comply with all trial procedures, and is capable of giving informed consent.

Exclusion criteria

Exclusion Criteria:

  • Any female who is breastfeeding, pregnant, or who is planning to become pregnant during the trial.
  • Active infection requiring treatment, including skin infections (including clinically infected AD).
  • History of skin disease or presence of a skin condition that, in the opinion of the Investigator, would interfere with trial assessments.
  • Any clinically significant medical or psychiatric condition or physical/laboratory/ECG/vital signs abnormality that would, in the opinion of the Investigator, put the participant at undue risk or interfere with interpretation of trial results.

  • Use of any of the following treatments within the indicated washout period before Day 1:

    1. Doxepin, hydroxyzine, or diphenhydramine use within 1 week prior to Day 1.
    2. Use of topical product containing urea or any antihistamine within 1 week prior to Day 1.
    3. Use of systemic antibiotic within 2 weeks, or topical antibiotics within 1 week, prior to Day 1.
    4. Atopic dermatitis topical medication use within 2 weeks prior to Day 1, including, but not limited to, topical corticosteroids, crisaborole and any other topical phosphodiesterase-4 inhibitor, calcineurin inhibitors, JAK inhibitors, tars, bleach, antimicrobials, medical devices, and bleach or oatmeal baths.
    5. Psoralen-UV-A or UV-B phototherapy (including tanning beds) or excimer laser within 4 weeks prior to Day
    6. Systemic medication use including biologics that could affect AD less than 6 weeks prior to Day 1 (e.g., retinoids, calcineurin inhibitors, methotrexate, cyclosporine, hydroxycarbamide [hydroxyurea], azathioprine, oral/injectable corticosteroids), biologics and JAK inhibitors.
  • Known hypersensitivity to ASN008 or its excipients.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
144 participants (actual)

Study arms

  • Experimental
    ASN008 1.25%

    ASN008 1.25% twice daily topical application applied as a thin layer (approximately 2 mg/cm\^2) for 4 weeks (28 days)

    Drug: ASN008

  • Experimental
    ASN008 2.5%

    ASN008 2.5% twice daily topical application applied as a thin layer (approximately 2 mg/cm\^2) for 4 weeks (28 days)

    Drug: ASN008

  • Experimental
    ASN008 5%

    ASN008 5% twice daily topical application applied as a thin layer (approximately 2 mg/cm\^2) for 4 weeks (28 days)

    Drug: ASN008

  • Placebo comparator
    ASN008 Matching Vehicle

    ASN008 matching vehicle twice daily topical application applied as a thin layer (approximately 2 mg/cm\^2) for 4 weeks (28 days)

    Other: ASN008 Matching Vehicle

Interventions

  • DrugASN008

    ASN008 topical gel applied twice daily.

  • OtherASN008 Matching Vehicle

    The ASN008 matching vehicle formulation matches the formulation of each ASN008 topical gel dose, but contains no ASN008.

06

What researchers measure

Primary outcomes

  1. Daily Peak Pruritus Numerical Rating Scale (NRS)

    Percent change of 7-day average daily peak pruritus NRS from Baseline to Week 4

    Time frame: Baseline to Week 4

Secondary outcomes

  1. Pruritus Response of ASN008 Topical Gel on Atopic Dermatitis (AD) Assessed by Daily Peak Pruritus NRS

    Pruritus response defined as 7-day average of daily peak pruritus NRS reduction greater than or equal to 4 points from Baseline to Week 4

    Time frame: Baseline to Week 4

  2. Mean Change From Baseline in Eczema Area and Severity Index (EASI) Score

    This outcome measure evaluates the change and percent change in the Eczema Area and Severity Index (EASI) score from Baseline to Week 4. The EASI score measures the extent and severity of eczema across four body regions: head/neck, trunk, upper limbs, and lower limbs. Two components are assessed: severity of erythema, edema/papulation, excoriation, and lichenification (each scored 0 to 3, with 0 = none and 3 = severe) and the surface area affected (scored 0 to 6, with 0 = no involvement and 6 = 90%-100% involvement). Subscale scores are combined using weighted multipliers for each region (head/neck 0.1, upper limbs 0.2, trunk 0.3, lower limbs 0.4) to calculate the total score. The EASI is a composite score ranging from 0 (no eczema) to 72 (maximum severity and extent). Scores are summed to account for the severity of lesions and the percentage of body surface area (BSA) affected in each region.

    Time frame: Baseline to Week 4

  3. Mean Change From Baseline in Total Body Surface Area (BSA)

    Change from Baseline in total BSA at week 4.

    Time frame: Baseline to Week 4

  4. Mean Change From Baseline in the Patient-Oriented Eczema Measure (POEM)

    This outcome measure evaluates the change in the the Patient-Oriented Eczema Measure (POEM) score from Baseline to Week 4.The POEM is a self-assessment tool that evaluates eczema severity based on patient-reported symptoms over the previous week. It includes 7 questions addressing common symptoms: itch, sleep disturbance, bleeding, weeping, cracking, flaking, and dryness. Each question is scored on a scale from 0 to 4 based on frequency (0 = no days, 1 = 1-2 days, 2 = 3-4 days, 3 = 5-6 days, 4 = every day). The scores are summed to generate a total score ranging from 0 to 28. Scores are interpreted as follows: 0-2 = clear or almost clear, 3-7 = mild eczema, 8-16 = moderate eczema, 17-24 = severe eczema, and 25-28 = very severe eczema. Higher scores indicate a greater symptom burden and worse disease severity.

    Time frame: Baseline to Week 4

Other outcomes

  1. Inter- and Intra-subject Variability of ASN008 Pharmacokinetics (PK) Characterized by Peak Plasma Concentration (Cmax)

    ASN008 PK will be characterized using population-based methods to include Peak Plasma Concentration (Cmax).

    Time frame: Baseline and Week 4

  2. Inter- and Intra-subject Variability of ASN008 Pharmacokinetics Characterized by Area Under the Plasma Concentration Versus Time Curve (AUC)

    ASN008 PK will be characterized using population-based methods to include area under the plasma concentration versus time curve (AUC)

    Time frame: Baseline and Week 4

  3. Number of Treatment Emergent Adverse Events (TEAEs)

    Number of participants who experienced a TEAE.

    Time frame: Baseline to Day 56

  4. Number of Investigational Product (IP)-Related TEAEs

    Number of participants who experienced an IP-related TEAE.

    Time frame: Baseline to Day 56

  5. Incidence of TEAEs Leading to Treatment Discontinuation

    Incidence of TEAEs leading to treatment discontinuation from first dose through completion of follow-up period (up to a maximum of 56 days)

    Time frame: Baseline to Day 56

07

Results

Posted Dec 27, 2024
Limitations and caveats
This trial included an exploratory evaluation of ASN008 pharmacokinetics (PK) as a secondary endpoint using population-based methods. During the analysis, quantifiable levels of ASN008 were unexpectedly observed in vehicle and pre-dose plasma samples. Follow-up investigation indicated this may have been related to assay limitations, which would confound the population PK analysis. Therefore, the analysis was not pursued.

Participant flow

Randomized
Participant flow — Randomized
MilestoneASN008 1.25%ASN008 2.5%ASN008 5%ASN008 Matching Vehicle
Started36363636
Completed34323233
Not completed2443
Withdrew: Did not receive study treatment2443
Treatment Period
Participant flow — Treatment Period
MilestoneASN008 1.25%ASN008 2.5%ASN008 5%ASN008 Matching Vehicle
Started34323233
Completed33292830
Not completed1343
Withdrew: Adverse event1111
Withdrew: Lost to follow-up0120
Withdrew: Protocol violation0001
Withdrew: Withdrawal by subject0111

Outcome measures

PrimaryDaily Peak Pruritus Numerical Rating Scale (NRS)

Percent change of 7-day average daily peak pruritus NRS from Baseline to Week 4

Time frame:
Baseline to Week 4
Reported as:
Least squares mean · percent change
Daily Peak Pruritus Numerical Rating Scale (NRS)
percent changeASN008 1.25%ASN008 2.5%ASN008 5%ASN008 Matching Vehicle
Daily Peak Pruritus Numerical Rating Scale (NRS)-45.6 ± 5.04-55.8 ± 5.13-48.3 ± 5.2-49.9 ± 4.99
Statistical analysis
  • ASN008 1.25% vs ASN008 Matching Vehicle · Mixed Models Analysis · p = 0.5483 · Mean difference (final values): 4.28
  • ASN008 2.5% vs ASN008 Matching Vehicle · Mixed Models Analysis · p = 0.4123 · Mean difference (final values): -5.89
  • ASN008 5% vs ASN008 Matching Vehicle · Mixed Models Analysis · p = 0.8177 · Mean difference (final values): 1.66
SecondaryPruritus Response of ASN008 Topical Gel on Atopic Dermatitis (AD) Assessed by Daily Peak Pruritus NRS

Pruritus response defined as 7-day average of daily peak pruritus NRS reduction greater than or equal to 4 points from Baseline to Week 4

Time frame:
Baseline to Week 4
Reported as:
Count of participants · Participants
Pruritus Response of ASN008 Topical Gel on Atopic Dermatitis (AD) Assessed by Daily Peak Pruritus NRS
ParticipantsASN008 1.25%ASN008 2.5%ASN008 5%ASN008 Matching Vehicle
Pruritus Response of ASN008 Topical Gel on Atopic Dermatitis (AD) Assessed by Daily Peak Pruritus NRS12221515
Statistical analysis
  • ASN008 1.25% vs ASN008 Matching Vehicle · Fisher Exact · p = 0.4601 · Odds ratio (or): 0.66
  • ASN008 2.5% vs ASN008 Matching Vehicle · Fisher Exact · p = 0.0804 · Odds ratio (or): 2.64
  • ASN008 5% vs ASN008 Matching Vehicle · Fisher Exact · p = >0.9999 · Odds ratio (or): 1.06
SecondaryMean Change From Baseline in Eczema Area and Severity Index (EASI) Score

This outcome measure evaluates the change and percent change in the Eczema Area and Severity Index (EASI) score from Baseline to Week 4. The EASI score measures the extent and severity of eczema across four body regions: head/neck, trunk, upper limbs, and lower limbs. Two components are assessed: severity of erythema, edema/papulation, excoriation, and lichenification (each scored 0 to 3, with 0 = none and 3 = severe) and the surface area affected (scored 0 to 6, with 0 = no involvement and 6 = 90%-100% involvement). Subscale scores are combined using weighted multipliers for each region (head/neck 0.1, upper limbs 0.2, trunk 0.3, lower limbs 0.4) to calculate the total score. The EASI is a composite score ranging from 0 (no eczema) to 72 (maximum severity and extent). Scores are summed to account for the severity of lesions and the percentage of body surface area (BSA) affected in each region.

Time frame:
Baseline to Week 4
Reported as:
Least squares mean · score on a scale
Mean Change From Baseline in Eczema Area and Severity Index (EASI) Score
score on a scaleASN008 1.25%ASN008 2.5%ASN008 5%ASN008 Matching Vehicle
Mean Change From Baseline in Eczema Area and Severity Index (EASI) Score-2.7 ± 0.40-3.5 ± 0.43-2.6 ± 0.45-3.4 ± 0.41
Statistical analysis
  • ASN008 1.25% vs ASN008 Matching Vehicle · Mixed Models Analysis · p = 0.2146 · Mean difference (final values): 0.72
  • ASN008 2.5% vs ASN008 Matching Vehicle · Mixed Models Analysis · p = 0.8851 · Mean difference (final values): -0.09
  • ASN008 5% vs ASN008 Matching Vehicle · Mixed Models Analysis · p = 0.1835 · Mean difference (final values): 0.81
SecondaryMean Change From Baseline in Total Body Surface Area (BSA)

Change from Baseline in total BSA at week 4.

Time frame:
Baseline to Week 4
Reported as:
Least squares mean · Percentage
Mean Change From Baseline in Total Body Surface Area (BSA)
PercentageASN008 1.25%ASN008 2.5%ASN008 5%ASN008 Matching Vehicle
Mean Change From Baseline in Total Body Surface Area (BSA)-2.6 ± 0.56-2.9 ± 0.59-1.5 ± 0.60-2.4 ± 0.56
Statistical analysis
  • ASN008 1.25% vs ASN008 Matching Vehicle · Mixed Models Analysis · p = 0.7982 · Mean difference (final values): -0.2
  • ASN008 2.5% vs ASN008 Matching Vehicle · Mixed Models Analysis · p = 0.5640 · Mean difference (final values): -0.5
  • ASN008 5% vs ASN008 Matching Vehicle · Mixed Models Analysis · p = 0.2939 · Mean difference (final values): 0.9
SecondaryMean Change From Baseline in the Patient-Oriented Eczema Measure (POEM)

This outcome measure evaluates the change in the the Patient-Oriented Eczema Measure (POEM) score from Baseline to Week 4.The POEM is a self-assessment tool that evaluates eczema severity based on patient-reported symptoms over the previous week. It includes 7 questions addressing common symptoms: itch, sleep disturbance, bleeding, weeping, cracking, flaking, and dryness. Each question is scored on a scale from 0 to 4 based on frequency (0 = no days, 1 = 1-2 days, 2 = 3-4 days, 3 = 5-6 days, 4 = every day). The scores are summed to generate a total score ranging from 0 to 28. Scores are interpreted as follows: 0-2 = clear or almost clear, 3-7 = mild eczema, 8-16 = moderate eczema, 17-24 = severe eczema, and 25-28 = very severe eczema. Higher scores indicate a greater symptom burden and worse disease severity.

Time frame:
Baseline to Week 4
Reported as:
Least squares mean · score on a scale
Mean Change From Baseline in the Patient-Oriented Eczema Measure (POEM)
score on a scaleASN008 1.25%ASN008 2.5%ASN008 5%ASN008 Matching Vehicle
Mean Change From Baseline in the Patient-Oriented Eczema Measure (POEM)-5.0 ± 1.04-7.8 ± 1.08-6.3 ± 1.11-6.4 ± 1.06
Statistical analysis
  • ASN008 1.25% vs ASN008 Matching Vehicle · Mixed Models Analysis · p = 0.3579 · Mean difference (final values): 1.4
  • ASN008 2.5% vs ASN008 Matching Vehicle · Mixed Models Analysis · p = 0.3466 · Mean difference (final values): -1.4
  • ASN008 5% vs ASN008 Matching Vehicle · Mixed Models Analysis · p = 0.9527 · Mean difference (final values): 0.1
Other pre-specifiedInter- and Intra-subject Variability of ASN008 Pharmacokinetics (PK) Characterized by Peak Plasma Concentration (Cmax)

ASN008 PK will be characterized using population-based methods to include Peak Plasma Concentration (Cmax).

Time frame:
Baseline and Week 4

Results for this outcome have not been posted.

Other pre-specifiedInter- and Intra-subject Variability of ASN008 Pharmacokinetics Characterized by Area Under the Plasma Concentration Versus Time Curve (AUC)

ASN008 PK will be characterized using population-based methods to include area under the plasma concentration versus time curve (AUC)

Time frame:
Baseline and Week 4

Results for this outcome have not been posted.

Other pre-specifiedNumber of Treatment Emergent Adverse Events (TEAEs)

Number of participants who experienced a TEAE.

Time frame:
Baseline to Day 56
Reported as:
Count of participants · Participants
Number of Treatment Emergent Adverse Events (TEAEs)
ParticipantsASN008 1.25%ASN008 2.5%ASN008 5%ASN008 Matching Vehicle
Number of Treatment Emergent Adverse Events (TEAEs)1214118
Other pre-specifiedNumber of Investigational Product (IP)-Related TEAEs

Number of participants who experienced an IP-related TEAE.

Time frame:
Baseline to Day 56
Reported as:
Count of participants · Participants
Number of Investigational Product (IP)-Related TEAEs
ParticipantsASN008 1.25%ASN008 2.5%ASN008 5%ASN008 Matching Vehicle
Number of Investigational Product (IP)-Related TEAEs1331
Other pre-specifiedIncidence of TEAEs Leading to Treatment Discontinuation

Incidence of TEAEs leading to treatment discontinuation from first dose through completion of follow-up period (up to a maximum of 56 days)

Time frame:
Baseline to Day 56
Reported as:
Count of participants · Participants
Incidence of TEAEs Leading to Treatment Discontinuation
ParticipantsASN008 1.25%ASN008 2.5%ASN008 5%ASN008 Matching Vehicle
Incidence of TEAEs Leading to Treatment Discontinuation1111

Adverse events

Collected over Adverse event data were collected beginning after participant enrollment, before treatment, during treatment, and up to 28 days following the cessation of treatment, up to Day 56/Week 8.. Non-serious events are listed at a 1% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
ASN008 1.25%0/34 (0%)0/34 (0%)12/34 (35.3%)
ASN008 2.5%0/32 (0%)0/32 (0%)14/32 (43.8%)
ASN008 5%0/32 (0%)0/32 (0%)13/32 (40.6%)
ASN008 Matching Vehicle0/33 (0%)0/33 (0%)9/33 (27.3%)
Most frequent other events
Showing 10 of 47
Most frequent other events
EventASN008 1.25%ASN008 2.5%ASN008 5%ASN008 Matching Vehicle
NasopharyngitisInfections and infestations0/341/323/322/33
HeadacheNervous system disorders3/343/321/320/33
Protein Urine PresentInvestigations0/340/322/320/33
Pain in ExtremityMusculoskeletal and connective tissue disorders0/342/320/321/33
Urinary Tract InfectionInfections and infestations2/341/321/321/33
ArthralgiaMusculoskeletal and connective tissue disorders2/340/320/320/33
AnaemiaBlood and lymphatic system disorders0/341/320/320/33
GastritisGastrointestinal disorders0/340/321/320/33
NauseaGastrointestinal disorders0/340/321/320/33
ToothacheGastrointestinal disorders0/341/320/320/33

Baseline characteristics

Modified Intent to Treat Population

Age, Categorical
Age, Categorical(Participants)ASN008 1.25%ASN008 2.5%ASN008 5%ASN008 Matching VehicleTotal
<=18 years00000
Between 18 and 65 years29312928117
>=65 years513514
Age, Continuous
Age, Continuous(years)ASN008 1.25%ASN008 2.5%ASN008 5%ASN008 Matching VehicleTotal
Least squares mean47.7 ± 15.4541.8 ± 12.5443.3 ± 15.9546.5 ± 16.0444.9 ± 15.09
Sex/Gender, Customized
Sex/Gender, Customized(Participants)ASN008 1.25%ASN008 2.5%ASN008 5%ASN008 Matching VehicleTotal
Male141571046
Female2017252385
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)ASN008 1.25%ASN008 2.5%ASN008 5%ASN008 Matching VehicleTotal
Ethnicity : Hispanic or Latino1411151151
Ethnicity : Not Hispanic or Latino2021172280
Race: White2519232289
Race: Black or African American81171137
Race: Asian02103
Race: Native Hawaiian or Other Pacific Islander10001
Race: Other00101
08

Study locations

27 sites
  • TrialSpark Investigative Site 0106
    Scottsdale, Arizona 85255, United States
  • TrialSpark Investigative Site 0118
    Hot Springs, Arkansas 71913, United States
  • TrialSpark Investigative Site 0123
    Beverly Hills, California 90212, United States
  • TrialSpark Investigative Site 0113
    Fremont, California 94538, United States
  • TrialSpark Investigative Site 0101
    Los Angeles, California 90057, United States
  • TrialSpark Investigative Site 0103
    Miami Lakes, Florida 33014, United States
  • TrialSpark Investigative Site 0129
    Miramar, Florida 33027, United States
  • TrialSpark Investigative Site 0131
    Clarksville, Indiana 47129, United States
  • TrialSpark Investigative Site 0109
    Indianapolis, Indiana 46250, United States
  • TrialSpark Investigative Site 0112
    Louisville, Kentucky 40241, United States
  • TrialSpark Investigative Site 0108
    Baton Rouge, Louisiana 70808, United States
  • TrialSpark Investigative Site 0124
    Monroe, Louisiana 71201, United States
  • TrialSpark Investigative Site 0107
    Auburn Hills, Michigan 48326, United States
  • TrialSpark Investigative Site 0102
    Saint Joseph, Missouri 54506, United States
  • TrialSpark Investigative Site 0115
    Kew Gardens, New York 11415, United States
  • TrialSpark Investigative Site 0119
    New York, New York 10075, United States
  • TrialSpark Investigative Site 0105
    Wilmington, North Carolina 28405, United States
  • TrialSpark Investigative Site 0125
    Mason, Ohio 45040, United States
  • TrialSpark Investigative Site 0127
    Oklahoma City, Oklahoma 73170, United States
  • TrialSpark Investigative Site 0122
    Philadelphia, Pennsylvania 19103, United States
  • TrialSpark Investigative Site 0121
    Houston, Texas 77056, United States
  • TrialSpark Investigative Site 0130
    Pflugerville, Texas 78660, United States
  • TrialSpark Investigative Site 0114
    San Antonio, Texas 78213, United States
  • TrialSpark Investigative Site 0126
    San Antonio, Texas 78229, United States
  • TrialSpark Investigative Site 0110
    Springville, Utah 84663, United States
  • TrialSpark Investigative Site 0117
    Richmond, Virginia 23226, United States
  • TrialSpark Investigative Site 0128
    Spokane, Washington 99202, United States
09

References and documents

Study documents

  • Study protocol · Jul 5, 2023
  • Statistical analysis plan · Jan 18, 2024

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 16, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT05870865
Lead sponsor
TrialSpark
Responsible party
Sponsor
First posted
May 23, 2023
Start date
May 3, 2023
Primary completion
Nov 27, 2023
Completion
Dec 28, 2023
Results posted
Dec 27, 2024
Last update
May 16, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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