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Atopic DermatitisPhase 3NCT03912259

Evaluation of Dupilumab in Chinese Adult Patients With Moderate to Severe Atopic Dermatitis

A Phase 3 study testing Dupilumab and Emollient (moisturizer) in people with Atopic Dermatitis, run by Sanofi at 27 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Primary Objective: To evaluate the efficacy of dupilumab monotherapy compared to placebo treatment in adult participants with moderate-to-severe atopic dermatitis (AD). Secondary Objectives: To evaluate the safety of dupilumab monotherapy compared to placebo treatment in adult participants with moderate-to-severe AD. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Atopic Dermatitis
What is being tested?
Dupilumab and Emollient (moisturizer)
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
165 participants
Where
27 sitesChina
Study dates
19 Dec 2018to 14 Feb 2020
Phase
Phase 3
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female, 18 years or older.
  • AD (according to American Academy of Dermatology Consensus Criteria, 2014) that had been present for at least 3 years before the screening visit.
  • Eczema Area and Severity Index (EASI) score greater than or equal to (>=) 16 at the screening and baseline visits.
  • Investigator's Global Assessment (IGA) score >=3 (on the 0 to 4 IGA scale, in which 3 was moderate and 4 was severe) at the screening and baseline visits.
  • Participants with >=10 percent (%) body surface area (BSA) of AD involvement at the screening and baseline visits.
  • Baseline Pruritus Numerical Rating Scale (NRS) average score for maximum itch intensity >=4.
  • Documented recent history (within 6 months before the screening visit) of inadequate response to treatment with topical medications or for whom topical treatments were otherwise medically inadvisable (e.g., because of important side effects or safety risks).

Who cannot join

  • Had used any of the following treatments within 4 weeks before the baseline visit, or any condition that, in the opinion of the investigator, was likely to require such treatment(s) during the first 4 weeks of study treatment:
  • Immunosuppressive/immunomodulating drugs (e.g., systemic corticosteroids, cyclosporine, mycophenolate-mofetil, interferon-gamma [IFN-γ], Janus kinase inhibitors, azathioprine, methotrexate);
  • Phototherapy for AD.
  • Treatment with topical corticosteroids (TCS) or topical calcineurin inhibitors (TCI) within 1 week before the baseline visit.
  • Treatment with systemic Traditional Chinese Medicine (TCM) within 4 weeks before the baseline visit or treatment with topical TCM within 1 week before the baseline visit.
  • Treatment with biologics as follows:
Show all 15Show fewer
  • Any cell-depleting agents including but not limited to rituximab: within 6 months before the baseline visit, or until lymphocyte count returns to normal, whichever is longer;
  • Other biologics: within 5 half-lives (if known) or 16 weeks prior to baseline visit, whichever was longer.
  • Initiation of treatment of AD with prescription moisturizers or moisturizers containing additives such as ceramide, hyaluronic acid, urea, or filaggrin degradation products during the screening period (participants may continue using stable doses of such moisturizers if initiated before the screening visit).
  • Regular use (more than 2 visits per week) of a tanning booth/parlor within 4 weeks of the baseline visit.
  • Treatment with a live (attenuated) vaccine within 12 weeks before the baseline visit.
  • Active chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks before the baseline visit, or superficial skin infections within 1 week before the baseline visit. NOTE: participants may be rescreened after infection resolves.
  • Known or suspected history of immunosuppression, including history of invasive opportunistic infections (e.g., tuberculosis [TB], histoplasmosis, listeriosis, coccidioidomycosis, pneumocystosis, aspergillosis) despite infection resolution: or unusually frequent, recurrent, or prolonged infections, per investigator judgment.
  • Active TB, latent untreated TB or a history of incompletely treated TB or non-tuberculous mycobacterial infection were excluded from the study unless that was well documented by a specialist that the participants had adequately treated and could then start treatment with a biologic agent, in the medical judgment of the Investigator and/or infectious disease specialist. TB testing would be performed according to local guidelines if required by regulatory authorities or ethics committees.
  • The above information was not intended to contain all considerations relevant to a participants potential participation in a clinical trial.

Trial locations and contacts

27 sites in 1 country.

27 sites in 1 country

China27 sites

  • Investigational Site Number 1560019

    Beijing, 100034

  • Investigational Site Number 1560001

    Beijing, 100044

  • Investigational Site Number 1560004

    Beijing, 100050

  • Investigational Site Number 1560003

    Beijing, 100191

  • Investigational Site Number 1560010

    Beijing, 100730

  • Investigational Site Number 1560021

    Changchun, 130021

  • Investigational Site Number 1560006

    Changsha, 410011

  • Investigational Site Number 1560017

    Chongqing, 400038

  • Investigational Site Number 1560026

    Hangzhou, 310006

  • Investigational Site Number 1560007

    Hangzhou, 310009

  • Investigational Site Number 1560013

    Jinan, 250013

  • Investigational Site Number 1560020

    Kunming

  • Investigational Site Number 1560030

    Lianyungang, 222002

  • Investigational Site Number 1560022

    Nanjing, 210042

  • Investigational Site Number 1560029

    Ningbo

  • Investigational Site Number 1560016

    Shanghai, 200040

  • Investigational Site Number 1560023

    Shanghai, 200092

  • Investigational Site Number 1560018

    Shanghai, 200433

  • Investigational Site Number 1560015

    Shanghai, 200443

  • Investigational Site Number 1560002

    Shenyang, 110001

  • Investigational Site Number 1560005

    Shenyang, 110001

  • Investigational Site Number 1560008

    Shenyang, 110004

  • Investigational Site Number 1560024

    Shenzhen

  • Investigational Site Number 1560027

    Tianjin, 300052

  • Investigational Site Number 1560028

    Wuxi, 214002

  • Investigational Site Number 1560012

    Xi'an, 710004

  • Investigational Site Number 1560025

    Yancheng

Other trials in China

About this study

Official title: A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Dupilumab in Chinese Adult Patients With Moderate-to-severe Atopic Dermatitis

Primary Objective:

To evaluate the efficacy of dupilumab monotherapy compared to placebo treatment in adult participants with moderate-to-severe atopic dermatitis (AD).

Secondary Objectives:

  • To evaluate the safety of dupilumab monotherapy compared to placebo treatment in adult participants with moderate-to-severe AD.
  • To evaluate the effect of dupilumab on improving patient reported outcomes (PROs).
  • To evaluate dupilumab immunogenicity.
Read the detailed description

The maximum study duration was 33 weeks per participants, including a screening period of up to 5 weeks, a 16-week randomized treatment period, and a 12-week follow-up period.

Being tested
Dupilumab, Placebo, Emollient (moisturizer)
Medical subject headings
Dermatitis, Atopic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DupilumabDrug

    Also called Dupixent, SAR231893

    Pharmaceutical form: solution,

    Route of administration: SC

  • PlaceboDrug

    Pharmaceutical form: solution,

    Route of administration: SC

  • Emollient (moisturizer)Drug

    Pharmaceutical form: cream,

    Route of administration: topical use

Study groups in NCT03912259
Study groupRoleWhat they receive
Placebo Q2WPlacebo comparatorPlacebo matched to dupilumab 600 milligrams (mg) (loading dose), subcutaneously (SC) on Day 1 followed by placebo matched to dupilumab 300 mg once every 2 weeks (Q2W) for 16 weeks.
Receives: Drug: Placebo; Drug: Emollient (moisturizer)
Dupilumab 300 mg Q2WExperimentalDupilumab at a loading dose of 600 mg, SC on Day 1 followed by 300 mg, Q2W for 16 weeks.
Receives: Drug: Dupilumab; Drug: Emollient (moisturizer)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With Investigator's Global Assessment (IGA) Score of "0" or "1" and Reduction From Baseline of Greater Than or Equal to (>=) 2 Points at Week 16

    The IGA is an assessment instrument used to rate the severity of AD globally based on a 5-point scale ranging from (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe), higher score indicated higher severity.

    Measured: Baseline, Week 16

Secondary outcomes (25)

  1. Number of Participants With Eczema Area and Severity Index (EASI) - 75 Response (>= 75% Reduction in Score From Baseline) at Week 16

    EASI: Measure to assess severity and extent of AD based on 4 AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation] and lichenification). Each characteristic was assessed for severity by Investigator/designee on scale of "0" (absent) through "3" (severe) and scored separately for each of 4 body regions (head, trunk, upper and lower extremities). Total score range from 0 (minimum) to 72 (maximum), higher scores indicated greater severity of AD.

    Measured: Baseline, Week 16

  2. Number of Participants Who Achieved >=4 Points With Reduction From Baseline in Weekly Average of Peak Daily Pruritus Numerical Rating Scale (NRS) Score at Week 16

    Pruritus NRS was an assessment tool that was used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 [0 = no itch; 10 = worst itch imaginable]), higher scores indicated greater severity.

    Measured: Baseline, Week 16

  3. Number of Participants Who Achieved >=3 Points With Reduction From Baseline in Weekly Average of Peak Daily Pruritus Numerical Rating Scale Score at Week 16

    Pruritus NRS was an assessment tool that was used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 [0 = no itch; 10 = worst itch imaginable]), higher scores indicated greater severity.

    Measured: Baseline, Week 16

  4. Percentage Change From Baseline at Week 16 in Weekly Average of Peak Daily Pruritus NRS

    Pruritus NRS was an assessment tool that was used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 [0 = no itch; 10 = worst itch imaginable]), higher scores indicated greater severity.

    Measured: Baseline, Week 16

  5. Change From Baseline at Week 16 in Weekly Average of Peak Daily Pruritus NRS

    Pruritus NRS was an assessment tool that was used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 [0 = no itch; 10 = worst itch imaginable]), higher scores indicated greater severity.

    Measured: Baseline, Week 16

  6. Percentage Change From Baseline to Week 16 in EASI Score

    EASI: Measure to assess severity \& extent of AD based on 4 AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation] \& lichenification). Each characteristic was assessed for severity by Investigator/designee on scale of "0" (absent) through "3"(severe) \& scored separately for each of 4 body regions (head, trunk, upper \& lower extremities). Total score ranges from 0 (minimum) to 72 (maximum), higher scores indicated greater severity of AD.

    Measured: Baseline to Week 16

  7. Change From Baseline to Week 16 in Percent Body Surface Area (BSA) of AD Involvement

    BSA affected by AD was assessed for each section of the body (the possible highest score for each region was: head and neck [9%], anterior trunk [18%], back [18%], upper limbs [18%], lower limbs [36%], and genitals [1%]) and reported as a percentage of all major body sections combined. The reported percentage of BSA was combined percentage of all major body sections.

    Measured: Baseline to Week 16

  8. Change From Baseline to Week 16 in Dermatology Life Quality Index (DLQI) Total Score

    The DLQI was a validated questionnaire used to measure the impact of AD disease symptoms and treatment on health-related quality of life (QOL). DLQI consisting of a set of 10 questions which assess QOL over the past week. Responses to each questions were assessed on a scale of 0 to 3, where 0 is "not at all" and 3 is "very much". Scores from all 10 questions added up to give total DLQI scores ranged from 0 (not at all) to 30 (very much), higher scores indicated more impact on quality of life.

    Measured: Baseline to Week 16

  9. Change From Baseline to Week 16 in Patient Oriented Eczema Measure (POEM)

    The POEM is a 7-item self-assessment questionnaire that assesses disease symptoms on a scale ranging from 0 to 4 (0 = no days, 1 = 1 to 2 days, 2 = 3 to 4 days, 3 = 5 to 6 days, 4 = all days). The sum of the 7 items gives the total POEM score of 0 (absent disease) to 28 (severe disease). Higher scores indicated more severe disease and poor quality of life.

    Measured: Baseline to Week 16

  10. Percentage Change From Baseline to Week 2 in Weekly Average of Peak Daily Pruritus NRS

    Pruritus NRS was an assessment tool that was used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 [0 = no itch; 10 = worst itch imaginable]), higher scores indicated greater severity.

    Measured: Baseline to Week 2

  11. Percentage Change From Baseline to Week 16 in EuroQoL Five Dimensions Questionnaire (EQ-5D) Index Scores

    The EQ-5D is a standardized measure of health status which is consists of 2 parts; the descriptive system and the EQ visual analogue scale (EQVAS). The EQ-5D descriptive system includes 5 dimensions; mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension measured on 3 levels: "no problem" (level 1), "some problems" (level 2), "extreme problems" (level 3). The digits for 5 dimensions can be combined in a 5-digit number describing the respondent's health state. The 5 dimensional 3-level systems was converted into single index utility score between 0 to 1 that quantify health status, where 0 represents "death" and 1 represents "perfect health".

    Measured: Baseline to Week 16

  12. Percentage Change From Baseline to Week 16 in EuroQoL Five Dimensions Questionnaire Visual Analog Scale Scores

    The EQ-5D VAS records the respondent's self-rated health on a vertical, visual analogue scale ranged from 0-100 where 100 indicated "best imaginable health state" and 0 indicated "worst imaginable health state", higher scores indicated better outcome.

    Measured: Baseline to Week 16

  13. Absolute Change From Baseline to Week 16 in EQ-5D Index Scores

    The EQ-5D is a standardized measure of health status which consisted of 2 parts; the descriptive system and the EQVAS. The EQ-5D descriptive system includes 5 dimensions; mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension measured on 3 levels: "no problem" (level 1), "some problems" (level 2), "extreme problems" (level 3). The digits for 5 dimensions can be combined in a 5-digit number describing the respondent's health state. The 5 dimensional 3-level systems was converted into single index utility score between 0 to 1 that quantify health status, where 0 represents "death" and 1 represents "perfect health".

    Measured: Baseline to Week 16

  14. Absolute Change From Baseline to Week 16 in EuroQoL Five Dimensions Questionnaire Visual Analog Scale Scores

    The EQ-5D VAS records the respondent's self-rated health on a vertical, visual analogue scale ranged from 0-100 where 100 indicated "best imaginable health state" and 0 indicated "worst imaginable health state", higher scores indicated better outcome.

    Measured: Baseline to Week 16

  15. Number of Participants Who Achieve Reduction of IGA Score by >=2 From Baseline to Week 16

    The IGA is an assessment instrument used to rate the severity of AD globally, based on a 5-point scale ranging from (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe), higher score indicated higher severity. In this outcome measure, number of participants who achieved reduction from baseline of >=2 points in IGA score at Week 16 were reported.

    Measured: Baseline to Week 16

  16. Number of Participants Achieving IGA 0 to 1 and a Reduction of >=2 Points From Baseline Through Week 16

    The IGA is an assessment instrument used to rate the severity of AD globally based on a 5-point scale ranging from (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe), higher score indicated higher severity.

    Measured: Baseline, Week 2, Week 4, Week 8, Week 12, Week 16

  17. Absolute Change in EASI Score From Baseline at Weeks 2, 4, 8, 12 and 16

    EASI: Measure to assess severity \& extent of AD based on 4 AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation] \& lichenification). Each characteristic was assessed for severity by Investigator/designee on scale of "0" (absent) through "3" (severe) \& scored separately for each of 4 body regions (head, trunk, upper \& lower extremities). Total score range from 0 (minimum) to 72 (maximum), higher scores indicated greater severity of AD. Participants with missing EASI Score at each visit were imputed using MI (Multiple Imputation) method.

    Measured: Baseline, Week 2, Week 4, Week 8, Week 12, Week 16

  18. Percentage Change in EASI Score From Baseline at Weeks 2, 4, 8, 12 and 16

    EASI: Measure to assess severity \& extent of AD based on 4 AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation] \& lichenification). Each characteristic was assessed for severity by Investigator/designee on scale of "0" (absent) through "3" (severe) \& scored separately for each of 4 body regions (head, trunk, upper \& lower extremities). Total score range from 0 (minimum) to 72 (maximum), higher scores indicated greater severity of AD.

    Measured: Baseline, Week 2, Week 4, Week 8, Week 12, Week 16

  19. Number of Participants With EASI-50 (>=50% Improvement From Baseline) at Week 16

    EASI: Measure to assess severity \& extent of AD based on 4 AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation] \& lichenification). Each characteristic was assessed for severity by Investigator/designee on scale of "0" (absent) through "3" (severe) \& scored separately for each of 4 body regions (head, trunk, upper \& lower extremities). Total score range from 0 (minimum) to 72 (maximum), higher scores indicated greater severity of AD.

    Measured: Baseline, Week 16

  20. Number of Participants With EASI-90 (>=90% Improvement From Baseline) at Week 16

    EASI: Measure to assess severity \& extent of AD based on 4 AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation] \& lichenification). Each characteristic was assessed for severity by Investigator/designee on scale of "0" (absent) through "3" (severe) \& scored separately for each of 4 body regions (head, trunk, upper \& lower extremities). Total score range from 0 (minimum) to 72 (maximum), higher scores indicated greater severity of AD.

    Measured: Baseline, Week 16

  21. Absolute Change in Weekly Average of Peak Daily Pruritus NRS Score From Baseline Through Week 16

    Pruritus NRS was an assessment tool that was used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 [0 = no itch; 10 = worst itch imaginable]), higher scores indicated greater severity. Participants with missing Peak Daily Pruritus NRS Score at each visit were imputed using MI method.

    Measured: From Baseline Through Week 16

  22. Percentage Change in Weekly Average of Peak Daily Pruritus NRS Score From Baseline Through Week 16

    Pruritus NRS was an assessment tool that was used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 [0 = no itch; 10 = worst itch imaginable]), higher scores indicated greater severity. Participants with missing peak NRS scores at each visit were imputed using MI method.

    Measured: From Baseline Through Week 16

  23. Number of Participants Who Responded "Absence of Pruritus" or "Mild Pruritus" in the Pruritus Categorical Scale at Week 16

    The pruritus categorical scale was a 4-point scale used to assess symptoms of AD. The scale is rated as follows: 0: absence of pruritus; 1: mild pruritus (occasional slight itching/scratching); 2: moderate pruritus (constant or intermittent itching/scratching that does not disturb sleep) and 3: severe pruritus (bothersome itching/scratching that disturbs sleep), higher scores indicated worse outcome.

    Measured: Week 16

  24. Number of Days of Sick Leave/Missed School Days

    Participants who were employed or enrolled in school for full time were asked to report the number of sick leave/missed school days since the last study assessment. Participants were counted as Full time if the participant checked "Full time" at all visits through 16-week treatment period and participants were counted as Part time if the participant checked at least one "Part time" during 16-week treatment period.

    Measured: Week 16

  25. Percentage of Participants With at Least One Day Sick Leave/Missed School Days

    Participants who were employed or enrolled in school for full time were asked to report the number of sick leave/missed school days since the last study assessment. Participants were counted as Full time if the participant checked "Full time" at all visits through 16-week treatment period and participants were counted as Part time if the participant checked at least one "Part time" during 16-week treatment period.

    Measured: Week 16

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Apr 2019
  2. Study start19 Dec 2018
  3. Primary completion14 Feb 2020
  4. Study completion14 Feb 2020

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
165 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03912259
Sponsor's protocol ID
EFC15116
Other IDs
U1111-1190-7728
Status last verified
Dec 2023
First submitted
18 Dec 2018
Last updated
19 Dec 2023
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Publications

  • Mickevicius T, Pink AE, Bhogal M, O'Brart D, Robbie SJ. Dupilumab-Induced, Tralokinumab-Induced, and Belantamab Mafodotin-Induced Adverse Ocular Events-Incidence, Etiology, and Management. Cornea. 2023 Apr 1;42(4):507-519. doi: 10.1097/ICO.0000000000003162. Epub 2022 Dec 15.

    PubMed 36525340

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Dupilumab and Emollient (moisturizer) in people with Atopic Dermatitis, run by Sanofi at 27 sites in China.

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 7 inclusion and 15 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 19 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 27 sites in China. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 5 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Investigator's Global Assessment (IGA) Score of "0" or "1" and Reduction From Baseline of Greater Than or Equal to (>=) 2 Points at Week 16 (time frame: Baseline, Week 16). 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 NCT03912259, 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 19 Dec 2023.

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