Dermatitis, AtopicPhase 1/2NCT02655679
An Ascending Multiple Dose Study of VTP-38543 in Adult Participants With Mild to Moderate Atopic Dermatitis
A Phase 1/2 study testing VTP-38543 in people with Dermatitis, Atopic, run by Vitae Pharmaceuticals, Inc. at 12 sites in 2 countries.
Trial summary
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary clinical efficacy of VTP-38543 administered as a cream, twice-daily, for 28 days in otherwise healthy adult male and female participants with mild to moderate atopic dermatitis. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Dermatitis, Atopic
- What is being tested?
- VTP-38543
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 104 participants
- Where
- 12 sitesin 2 countries
- Study dates
- 15 Dec 2015to 9 Sep 2016
- Phase
- Phase 1/2
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Mild to moderate atopic dermatitis with a minimum of 3 to a maximum of 15% body surface area (BSA) involvement
- Investigator Global Assessments (IGA) score of 2 or 3
- Body Mass Index (BMI) = 18 - 35 kg/m^2
- Negative Pregnancy test for females
Who cannot join
- Treatment for atopic dermatitis with systemic medications, topical agents, and parenteral biological/monoclonal antibody agents, within specific time period prior to dosing.
- Organ dysfunction or any clinically significant deviation from normal in vital signs, physical examinations, labs, and Electrocardiogram (ECG) findings
- Major surgery within 3 months of Screening
- Use of prescription drugs, sedative antihistamine, medical devices for treatment of atopic dermatitis (AD), and topical products containing urea and/or ceramides within 14 prior to dosing
- Excessive sun exposures, use of tanning booths or other ultraviolet (UV) light sources 4 weeks prior to dosing
Trial locations and contacts
12 sites in 2 countries.
12 sites in 2 countries
Canada7 sites
Kirk Barber Research
Calgary, Alberta, T2G1B1CA
Dr Isabelle Delorme Inc
Drummondville, Quebec, J2B 5L4
Stratica Medical Inc
Edmonton, Alberta, T5K 1X3
Lynderm Research Inc
Markham, Ontario, L3P 1X2
Innovaderm Research
Montreal, Quebec, H2K4L5
The Center for Dermatology / Institution
Richmond Hill, Ontario, L4B 1A5
Windsor Clinical Research Inc
Windsor, Ontario, N8W 5L7
United States5 sites
Hamzavi Dermatology
Fort Gratiot, Michigan, 48059
Skin Specialty Dermatology
New York, New York, 10155
Paddington Testing Company, Inc
Philadelphia, Pennsylvania, 19103
Wake Research Associates, LLC
Raleigh, North Carolina, 27612
Dundee Dermatology
West Dundee, Illinois, 60118
About this study
Official title: A Randomized, Double-Blind, Vehicle-Controlled Ascending Multiple Dose and Clinical Proof-Of-Concept Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of VTP-38543 in Adult Patients With Mild to Moderate Atopic Dermatitis
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary clinical efficacy of VTP-38543 administered as a cream, twice-daily, for 28 days in otherwise healthy adult male and female participants with mild to moderate atopic dermatitis.
Read the detailed description
This is a randomized, double-blind, vehicle-controlled study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary clinical efficacy of VTP-38543 following twice-daily, every twelve hours (Q12h) administration for 28 days in otherwise healthy adult male and female participants with mild to moderate atopic dermatitis.
Evaluation of three ascending doses in three dose panels is planned for this trial. Dose Panel 1 (VTP-38543 0.05%) and Panel 2 (VTP-38543 0.15%) will each enroll 30 participants and randomize 20 to VTP-38543 and 10 to matching vehicle control (Vehicle without Transcutol®P). Dose Panel 3 (VTP-38543 1%) will enroll 40 participants and randomize 20 to VTP-38543 and 20 to matching vehicle control (Vehicle with Transcutol®P). A total of approximately 100 participants will participate in the trial.
- Conditions
- Dermatitis, Atopic
- Being tested
- VTP-38543, Vehicle with Transcutol®P, Vehicle without Transcutol®P
- Keywords
- Eczema
- Medical subject headings
- Dermatitis, Atopic, Eczema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VTP-38543Drug
VTP-38543 topical cream
Vehicle with Transcutol®POther
Also called Transcutol®P is Diethylene Glycol Monoethyl Ether, NF.
Vehicle matching VTP-38543 cream with Transcutol®P
Vehicle without Transcutol®POther
Also called Transcutol®P is Diethylene Glycol Monoethyl Ether, NF.
Vehicle matching VTP-38543 cream without Transcutol®P
| Study group | Role | What they receive |
|---|---|---|
| VTP-38543 0.05% | Experimental | VTP-38543 0.05% administered topically every 12 hours for 28 days. Receives: Drug: VTP-38543 |
| VTP-38543 0.15% | Experimental | VTP-38543 0.15% administered topically every 12 hours for 28 days. Receives: Drug: VTP-38543 |
| Vehicle without Transcutol®P | Placebo comparator | Vehicle without Transcutol®P administered topically every 12 hours for 28 days. Receives: Other: Vehicle without Transcutol®P |
| VTP-38543 1% | Experimental | VTP-38543 1% administered topically every 12 hours for 28 days. Receives: Drug: VTP-38543 |
| Vehicle with Transcutol®P | Placebo comparator | Vehicle with Transcutol®P administered topically every 12 hours for 28 days. Receives: Other: Vehicle with Transcutol®P |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment-related Adverse Events (AEs)
An Adverse Event is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The number of participants with AEs related to treatment are reported.
Measured: Baseline (Day 0) to Day 35
Number of Participants With Clinically Significant Changes in Clinical Laboratory Values
Clinical Laboratory tests included chemistry, hematology and urinalysis tests collected during the study. The investigator determined if the changes in laboratory results were clinically significant.
Measured: Baseline (Day 0) to Day 35
Number of Participants With Clinically Significant Changes in Vital Signs
Vital signs included blood pressure, pulse, respiration rate and body temperature. The investigator determined if the changes in vital sign results were clinically significant.
Measured: Baseline (Day 0) to Day 35
Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Values
A standard 12-lead ECG was performed. The investigator determined if the changes in ECG results were clinically significant.
Measured: Baseline (Day 0) to Day 35
Secondary outcomes (11)
Maximum Plasma Concentration (Cmax) for VTP-38543-001
Measured: Day 0 (pre-dose, 1, 2, 4, 6, 9, and 12 hours post first dose), and Day 27 (pre-dose, 1, 2, 4, 6, 9, 12, 24, 48, and 72 hours post last dose)
Time to Maximum Plasma Concentrations (Tmax) for VTP-38543
Measured: Day 0 (pre-dose, 1, 2, 4, 6, 9, and 12 hours post first dose), and Day 27 (pre-dose, 1, 2, 4, 6, 9, 12, 24, 48, and 72 hours post last dose)
Area Under the Plasma Concentration Versus Time Curve, From Time 0 to the Last Measurable Concentration (AUClast) for VTP-38543
Measured: Day 0 (pre-dose, 1, 2, 4, 6, 9, and 12 hours post first dose), and Day 27 (pre-dose, 1, 2, 4, 6, 9, 12, 24, 48, and 72 hours post last dose)
Area Under the Plasma Concentration Versus Time Curve, From Time 0 to 12 Hours (AUC0-12hr) for VTP-38543
Measured: Day 0 (pre-dose, 1, 2, 4, 6, 9, and 12 hours post first dose), and Day 27 (pre-dose, 1, 2, 4, 6, 9, 12, 24, 48, and 72 hours post last dose)
Elimination Half-life (t½) for VTP-38543
Measured: Day 0 (pre-dose, 1, 2, 4, 6, 9, and 12 hours post first dose), and Day 27 (pre-dose, 1, 2, 4, 6, 9, 12, 24, 48, and 72 hours post last dose)
Percentage Change From Baseline in Total Body Surface Area (BSA)
Percent BSA was estimated using the palmar surface of the participant's hand up to the proximal interphalangeal joint, including the thumb, to approximate 1% of the participant's BSA. The overall BSA affected by atopic dermatitis was evaluated from 0 to 100% and divided by 5 for a maximum of 20. A negative percentage change indicates improvement.
Measured: Baseline (Day 0) to Day 28
Percentage Change From Baseline in Investigator Global Assessments (IGA) Score
The investigator assessed the participant's atopic dermatitis using the 5-point IGA where 0=clear (Minor, residual discoloration, no erythema or induration/papulation, no oozing/crusting) to 4=Severe disease (Deep/bright red erythema with severe induration/papulation with oozing/crusting). A negative percentage change indicates improvement.
Measured: Baseline (Day 0) to Day 28
Percentage Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Score
The investigator assessed severity of atopic dermatitis (AD) using scoring atopic dermatitis (SCORAD) score obtained from different individual scales. 6-items: erythema, edema/papulation, oozing/crusts, excoriation, lichenification, and dryness were graded on a 4-point scale where 0=Absent to 3=Severe. The individual scores were added together to get a score of 0 to 18 that was multiplied by 3.5 for a score of 0 to 63. The overall BSA affected by AD (0 to 100 %) was divided by 5 for a score 0 to 20. The participant used a 10-point Visual Analog Scale (VAS) to evaluate loss of sleep and the occurrence of pruritus averaged over the last 3 days where 0=None to Worst Imaginable. The sum of the 2 VAS scores was 0 to 20. The above measures were added together for a total possible SCORAD score of 0 (best) to 103 (worst). A negative percentage change indicates improvement.
Measured: Baseline (Day 0) to Day 28
Percentage Change From Baseline Eczema Area and Severity Index (EASI)
The investigator assessed four body regions: Head and neck, Upper extremities, Trunk including axillae and groin, and Lower extremities including buttocks. Each body region was scored based on BSA where 0=No involvement to 6=90-100%. Each body region was assessed for erythema, infiltration/papulation, excoriation and lichenification using a 4-point scale where 0=None to 3=Severe. EASI total score was determined by combining the individual scores for each of the 4 body regions. The total for each region was calculated by [erythema + infiltration+ excoriation + lichenification * area involvement * a constant (constants Head and Neck=0.1, Upper Limbs=0.2, Trunk=0.3, Lower Limbs=0.4)]. The EASI total score was determined by combining the individual scores for each of the 4 body regions for a total possible score of 0 (best) to 72 (worst). A negative percentage change indicates improvement.
Measured: Baseline (Day 0) to Day 28
Percentage Change From Baseline in Pruritus VAS Score
The participant used a 10-point VAS to assess the occurrence of pruritus (itchy skin) over the last 3 days where 0= None to 10=Worst Imaginable for a total possible score of 0 to 10. A negative percentage change indicates improvement.
Measured: Baseline (Day 0) to Day 28
Percentage Change From Baseline in VAS Sleep Score
The participant used a 10-point VAS to evaluate loss of sleep averaged over the last 3 days where 0= None to 10=Worst imaginable for a total possible score of 0 to 10. A negative percentage change indicates improvement.
Measured: Baseline (Day 0) to Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2016 (estimated)
- Study start15 Dec 2015
- Primary completion9 Sep 2016
- Study completion9 Sep 2016
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 (1)Papers the sponsor has linked to this study.
- Other trials for Dermatitis, AtopicStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vitae Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christy Harutunian, Study director, Allergan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02655679
- Sponsor's protocol ID
- VTP-38543-001
- Status last verified
- Jan 2019
- First submitted
- 11 Jan 2016
- Last updated
- 15 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Czarnowicki T, Dohlman AB, Malik K, Antonini D, Bissonnette R, Chan TC, Zhou L, Wen HC, Estrada Y, Xu H, Bryson C, Shen J, Lala D, Ma'ayan A, McGeehan G, Gregg R, Guttman-Yassky E. Effect of short-term liver X receptor activation on epidermal barrier features in mild to moderate atopic dermatitis: A randomized controlled trial. Ann Allergy Asthma Immunol. 2018 Jun;120(6):631-640.e11. doi: 10.1016/j.anai.2018.03.013. Epub 2018 Mar 19.
PubMed 29567358
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Vehicle-Controlled Ascending Multiple Dose and Clinical Proof-Of-Concept Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of VTP-38543 in Adult Patients With Mild to Moderate Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT02655679
- Acronym / sponsor ID
- VTP-38543-001
- Conditions
- Dermatitis, Atopic
- Keywords
- Eczema
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Vitae Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 15 Dec 2015 (actual)
- Primary completion
- 9 Sep 2016 (actual)
- Study completion
- 9 Sep 2016 (actual)
- First posted
- 14 Jan 2016 (estimated)
- Results
- Posted 15 Feb 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary clinical efficacy of VTP-38543 administered as a cream, twice-daily, for 28 days in otherwise healthy adult male and female participants with mild to moderate atopic dermatitis.
Detailed description
This is a randomized, double-blind, vehicle-controlled study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary clinical efficacy of VTP-38543 following twice-daily, every twelve hours (Q12h) administration for 28 days in otherwise healthy adult male and female participants with mild to moderate atopic dermatitis.
Evaluation of three ascending doses in three dose panels is planned for this trial. Dose Panel 1 (VTP-38543 0.05%) and Panel 2 (VTP-38543 0.15%) will each enroll 30 participants and randomize 20 to VTP-38543 and 10 to matching vehicle control (Vehicle without Transcutol®P). Dose Panel 3 (VTP-38543 1%) will enroll 40 participants and randomize 20 to VTP-38543 and 20 to matching vehicle control (Vehicle with Transcutol®P). A total of approximately 100 participants will participate in the trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| VTP-38543 0.05% | Experimental | Drug: VTP-38543VTP-38543 0.05% administered topically every 12 hours for 28 days. |
| VTP-38543 0.15% | Experimental | Drug: VTP-38543VTP-38543 0.15% administered topically every 12 hours for 28 days. |
| Vehicle without Transcutol®P | Placebo comparator | Other: Vehicle without Transcutol®PVehicle without Transcutol®P administered topically every 12 hours for 28 days. |
| VTP-38543 1% | Experimental | Drug: VTP-38543VTP-38543 1% administered topically every 12 hours for 28 days. |
| Vehicle with Transcutol®P | Placebo comparator | Other: Vehicle with Transcutol®PVehicle with Transcutol®P administered topically every 12 hours for 28 days. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Mild to moderate atopic dermatitis with a minimum of 3 to a maximum of 15% body surface area (BSA) involvement
- Investigator Global Assessments (IGA) score of 2 or 3
- Body Mass Index (BMI) = 18 - 35 kg/m^2
- Negative Pregnancy test for females
Key exclusion criteria (5 listed)
- Treatment for atopic dermatitis with systemic medications, topical agents, and parenteral biological/monoclonal antibody agents, within specific time period prior to dosing.
- Organ dysfunction or any clinically significant deviation from normal in vital signs, physical examinations, labs, and Electrocardiogram (ECG) findings
- Major surgery within 3 months of Screening
- Use of prescription drugs, sedative antihistamine, medical devices for treatment of atopic dermatitis (AD), and topical products containing urea and/or ceramides within 14 prior to dosing
- Excessive sun exposures, use of tanning booths or other ultraviolet (UV) light sources 4 weeks prior to dosing
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 |
|---|---|---|
| VTP-38543VTP-38543 topical cream | Drug | VTP-38543 0.05%, VTP-38543 0.15%, VTP-38543 1% |
| Vehicle with Transcutol®PAlso: Transcutol®P is Diethylene Glycol Monoethyl Ether, NF.Vehicle matching VTP-38543 cream with Transcutol®P | Other | Vehicle with Transcutol®P |
| Vehicle without Transcutol®PAlso: Transcutol®P is Diethylene Glycol Monoethyl Ether, NF.Vehicle matching VTP-38543 cream without Transcutol®P | Other | Vehicle without Transcutol®P |
Primary outcome
Number of Participants With Treatment-related Adverse Events (AEs)
Time frame: Baseline (Day 0) to Day 35
An Adverse Event is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The number of participants with AEs related to treatment are reported.
Number of Participants With Clinically Significant Changes in Clinical Laboratory Values
Time frame: Baseline (Day 0) to Day 35
Clinical Laboratory tests included chemistry, hematology and urinalysis tests collected during the study. The investigator determined if the changes in laboratory results were clinically significant.
Number of Participants With Clinically Significant Changes in Vital Signs
Time frame: Baseline (Day 0) to Day 35
Vital signs included blood pressure, pulse, respiration rate and body temperature. The investigator determined if the changes in vital sign results were clinically significant.
Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Values
Time frame: Baseline (Day 0) to Day 35
A standard 12-lead ECG was performed. The investigator determined if the changes in ECG results were clinically significant.
11 secondary outcomes
Maximum Plasma Concentration (Cmax) for VTP-38543-001
Time frame: Day 0 (pre-dose, 1, 2, 4, 6, 9, and 12 hours post first dose), and Day 27 (pre-dose, 1, 2, 4, 6, 9, 12, 24, 48, and 72 hours post last dose)
Time to Maximum Plasma Concentrations (Tmax) for VTP-38543
Time frame: Day 0 (pre-dose, 1, 2, 4, 6, 9, and 12 hours post first dose), and Day 27 (pre-dose, 1, 2, 4, 6, 9, 12, 24, 48, and 72 hours post last dose)
Area Under the Plasma Concentration Versus Time Curve, From Time 0 to the Last Measurable Concentration (AUClast) for VTP-38543
Time frame: Day 0 (pre-dose, 1, 2, 4, 6, 9, and 12 hours post first dose), and Day 27 (pre-dose, 1, 2, 4, 6, 9, 12, 24, 48, and 72 hours post last dose)
Area Under the Plasma Concentration Versus Time Curve, From Time 0 to 12 Hours (AUC0-12hr) for VTP-38543
Time frame: Day 0 (pre-dose, 1, 2, 4, 6, 9, and 12 hours post first dose), and Day 27 (pre-dose, 1, 2, 4, 6, 9, 12, 24, 48, and 72 hours post last dose)
Elimination Half-life (t½) for VTP-38543
Time frame: Day 0 (pre-dose, 1, 2, 4, 6, 9, and 12 hours post first dose), and Day 27 (pre-dose, 1, 2, 4, 6, 9, 12, 24, 48, and 72 hours post last dose)
Percentage Change From Baseline in Total Body Surface Area (BSA)
Time frame: Baseline (Day 0) to Day 28
Percentage Change From Baseline in Investigator Global Assessments (IGA) Score
Time frame: Baseline (Day 0) to Day 28
Percentage Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Score
Time frame: Baseline (Day 0) to Day 28
Percentage Change From Baseline Eczema Area and Severity Index (EASI)
Time frame: Baseline (Day 0) to Day 28
Percentage Change From Baseline in Pruritus VAS Score
Time frame: Baseline (Day 0) to Day 28
Percentage Change From Baseline in VAS Sleep Score
Time frame: Baseline (Day 0) to Day 28
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29567358Czarnowicki T, Dohlman AB, Malik K, Antonini D, Bissonnette R, Chan TC, Zhou L, Wen HC, Estrada Y, Xu H, Bryson C, Shen J, Lala D, Ma'ayan A, McGeehan G, Gregg R, Guttman-Yassky E. Effect of short-term liver X receptor activation on epidermal barrier features in mild to moderate atopic dermatitis: A randomized controlled trial. Ann Allergy Asthma Immunol. 2018 Jun;120(6):631-640.e11. doi: 10.1016/j.anai.2018.03.013. Epub 2018 Mar 19.
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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.
Christy Harutunian study director
Allergan
12 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing VTP-38543 in people with Dermatitis, Atopic, run by Vitae Pharmaceuticals, Inc. at 12 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 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 15 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Canada, 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 15 Feb 2019). 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 With Treatment-related Adverse Events (AEs) (time frame: Baseline (Day 0) to Day 35). The study lists 4 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 NCT02655679, which also lists 1 linked publication.
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 15 Feb 2019.