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Atopic DermatitisPhase 2NCT03809663

A Dose Ranging Placebo-Controlled Double-Blind Study to Evaluate the Safety and Efficacy of Tezepelumab in Atopic Dermatitis

A Phase 2 study testing Tezepelumab in people with Atopic Dermatitis, run by Amgen at 86 sites in 15 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

This phase 2b study is designed to evaluate the safety and efficacy of tezepelumab as a monotherapy and explore its efficacy as adjunct therapy in subjects with moderate-to-severe atopic dermatitis (AD). Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Atopic Dermatitis
What is being tested?
Tezepelumab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
251 participants
Where
86 sitesin 15 countries
Study dates
15 Mar 2019to 22 Dec 2020
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subject has provided informed consent prior to initiation of any study specific activities/procedures.
  • Age greater than or equal to 18 to less than or equal to 75 years at screening.
  • Clinical diagnosis of chronic AD (also known as atopic eczema) for at least 2 years prior to screening and has confirmed AD (Hanifin and Rajka criteria for AD (Hanifin and Rajka, 1980).
  • AD that affects greater than or equal to' 10% body surface area as assessed by EASI at screening and on day 1.
  • An IGA score of greater than or equal to 3 at screening and on day 1.
  • An EASI score of greater than or equal to 16 at screening and on day 1.
Show all 9Show fewer
  • Subject discontinued treatment with TCS, topical calcineurin inhibitors (TCI), and prescription moisturizers containing TCS or topical calcineurin inhibitors (TCI) for at least the 7 days immediately prior to the first dose of investigational product
  • Documented recent history (within 12 months before the screening visit) of inadequate response totreatment with topical TCS or subjects for whom topical treatments are otherwise medically inadvisable (ie, because of important side effects or safety risks).
  • Inadequate response is defined as failure to achieve and maintain remission or a low disease activity state (comparable to IGA 0 = clear to IGA 2 = mild) despite treatment with a daily regimen of TCS of medium or higher potency (with or without TCI as appropriate).

Who cannot join

  • Active dermatologic conditions, which might confound the diagnosis of AD or would interfere with the assessment of treatment, such as scabies, seborrheic dermatitis, cutaneous lymphoma, ichthyosis, psoriasis, allergic contact dermatitis, or irritant contact dermatitis.
  • History of a clinically significant infection within 28 days prior to day 1 that, in the opinion of the investigator or medical monitor, might compromise the safety of the subject in the study, interfere with evaluation of the investigational product, or reduce the subject's ability to participate in the study. Clinically significant infections are defined as either of the following: 1) a systemic infection; or 2) a serious skin infection requiring parenteral antibiotic, antiviral, or antifungal medication.
  • Diagnosis of a helminth parasitic infection within 6 months prior to screening that had not been treated with or had failed to respond to standard of care therapy.
  • Documented medical history of chronic alcohol or drug abuse within 12 months prior to screening.
  • History of anaphylaxis following any biologic therapy.
  • Evidence of active liver disease at screening, including jaundice or aspartate aminotransferase (AST), alanine aminotransferase (ALT), or alkaline phosphatase greater than twice the upper limit of normal (ULN).
Show all 30Show fewer
  • Subjects who, in the opinion of the investigator, have evidence of active tuberculosis (TB), either treated or untreated, or a positive QuantiFERON-tuberculosis Gold (QFT-G) test for TB during screening. Subjects with an indeterminate QFT-G may be enrolled if they have ALL of the following:
  • No symptoms of TB: productive, prolonged cough (> 3 weeks); coughing up blood; fever; night sweats; unexplained appetite loss; unintentional weight loss
  • No evidence of active TB on chest radiograph within 3 months prior to the first dose of investigational product. Note: Chest radiograph is not part of screening procedure and will be the responsibility
  • Positive hepatitis B surface antigen or hepatitis C antibody serology. Subjects with a history of hepatitis B vaccination without a history of hepatitis B are allowed to enroll in the study.
  • Positive human immunodeficiency virus (HIV) test at screening or the subject is taking antiretroviral medications, as determined by medical history, prior medications, and/or the subject's verbal report.
  • Other Medical Conditions>
  • History of malignancy, except for basal cell carcinoma or in situ carcinoma of the cervix treated with apparent success with curative therapy ≥ 12 months prior to screening or other malignancies treated with apparent success with curative therapy ≥ 5 years prior to screening.
  • History or evidence of severe depression, schizophrenia, previous suicide attempts, or suicidal ideation.
  • Prior/Concomitant Therapy:
  • Subjects who are unwilling to abstain from the use of TCS, TCI, and prescription moisturizers (those that contain TCS and TCI) from screening through week 16 (applies only to Part A subjects)
  • Subjects who have had side effects of topical medications including intolerance to treatment, hypersensitivity reactions, significant skin atrophy, or systemic effects as assessed by the investigator or by the subject's treating physician (applies only to Part B subjects)
  • More than or equal to 30% of the total lesional surface is located on areas of thin skin that cannot be safely treated with medium or higher potency TCS (eg, face, neck, intertriginous areas, areas of skin atrophy) (applies only to Part B subjects)
  • Receipt of any approved biologic agent (eg, dupilumab) within 4 months or 5 elimination half-lives (whichever is longer) prior to screening
  • Have used immunosuppressive/immunomodulating drugs (eg, systemic corticosteroids, cyclosporine, mycophenolate-mofetil, interferon (IFN)-gamma, Janus kinase inhibitors, azathioprine, methotrexate) within 4 weeks prior to screening, or any condition that, in the opinion of the investigator, is likely to require such treatment(s) during the first 4 weeks of study treatment.
  • Have had phototherapy for AD in the 2 months prior to day 1, and subjects unwilling to avoid phototherapy during the first 16 weeks of the study
  • If on allergen-specific immunotherapy, subjects must be on a maintenance dose and schedule for ≥ 28 days prior to screening. Allergen-specific immunotherapy is defined as SC immunotherapy to aeroallergens and/o venom (Hymenoptera) as well as sublingual immunotherapy to aeroallergens
  • Vaccination with a live or attenuated vaccine within 28 days prior to day 1. Receipt of inactive/killed vaccinations (eg, inactive influenza) is allowed. Note that receipt of the Th2 cytokine inhibitor suplatast within 15 days prior to randomization and during the study is not allowed.
  • Major surgery within 8 weeks prior to screening or planned inpatient surgery or hospitalization during the study period
  • Currently receiving treatment in another investigational device or drug study, or less than 6 months since ending treatment on another investigational device or drug study(ies). Other investigational procedures while participating in this study are excluded.
  • Other Exclusions:
  • Female subject is pregnant or breastfeeding or planning to become pregnant or breastfeed during treatment and for an additional 16 weeks after the last dose of investigational product. (Females of childbearing potential should only be enrolled in the study after a negative highly sensitive serum pregnancy test).
  • Female subjects of childbearing potential who are sexually active with unsterilized male partners unwilling to use 1 highly effective method of contraception during treatment and for an additional 16 weeks after the last dose of investigational product. Cessation of contraception after this point must be discussed with a responsible physician. Females of childbearing potential are defined as those who are not surgically sterile (ie, had bilateral tubal ligation, bilateral oophorectomy, or complete hysterectomy) or postmenopausal (defined as 12 months with no menses without an alternative medical cause). A highly effective method of contraception is defined as one that resulted in a low failure rate (ie, < 1% per year) when used consistently and correctly.
  • Subject has known sensitivity to any of the products or components to be administered during dosing.
  • History or evidence of any other clinically significant disorder, condition or disease (with the exception of those outlined above) that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion.

Trial locations and contacts

86 sites in 15 countries.

86 sites in 15 countries

United States16 sites

  • Hamilton Research, LLC

    Alpharetta, Georgia, 30022

  • Clarkston Skin Research

    Clarkston, Michigan, 48346

  • DS Research

    Clarksville, Indiana, 47129

  • Modern Research Associates

    Dallas, Texas, 75231

  • First OC Dermatology

    Fountain Valley, California, 92708

  • J Woodson Dermatology and Associates

    Henderson, Nevada, 89052

  • Skin Sciences Pllc

    Louisville, Kentucky, 40217

  • Scott Health Services LLC

    Louisville, Kentucky, 40241

  • Tennessee Clinical Research Center

    Nashville, Tennessee, 37215

  • Mount Sinai Hospital

    New York, New York, 10029

  • Epiphany Dermatology of Kansas, LLC

    Overland Park, Kansas, 66215

  • Clinical Science Institute

    Santa Monica, California, 90404

  • Premier Clinical Research

    Spokane, Washington, 99202

  • Southern Illinois University School of Medicine

    Springfield, Illinois, 62702

  • DermResearch Center of New York Inc

    Stony Brook, New York, 11790

  • Dundee Dermatology

    West Dundee, Illinois, 60118

Other trials in United States

Japan12 sites

  • Nippon Medical School Hospital

    Bunkyo-ku, Tokyo, 113-8603

  • Japan Post Holdings Co Ltd Tokyo Teishin Hospital

    Chiyoda-ku, Tokyo, 102-8798

  • Fukuoka University Hospital

    Fukuoka, Fukuoka, 814-0180

  • Nagasaki University Hospital

    Nagasaki, Nagasaki, 852-8501

  • Meiwa Hospital

    Nishinomiya-shi, Hyōgo, 663-8186

  • Takagi Dermatological Clinic

    Obihiro-shi, Hokkaido, 080-0013

  • Kume Clinic

    Sakai-shi, Osaka, 593-8324

  • Toho University Sakura Medical Center

    Sakura-shi, Chiba, 285-8741

  • Medical Corporation Kojinkai Sapporo Skin Clinic

    Sapporo, Hokkaido, 060-0063

  • NTT Medical Center Tokyo

    Shinagawa-ku, Tokyo, 141-8625

  • Center Hospital of the National Center for Global Health and Medicine

    Shinjuku-ku, Tokyo, 162-8655

  • Shirasaki Dermatology Clinic

    Takaoka-shi, Toyama, 933-0871

Other trials in Japan

Poland8 sites

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, 80-214

  • Centrum Terapii Wspolczesnej J M Jasnorzewska Spolka Komandytowo-Akcyjna

    Lodz, 90-242

  • Dermoklinika Centrum Medyczne Spolka cywilna M Kierstan J Narbutt A Lesiak

    Lodz, 90-436

  • Niepubliczny Zaklad Opieki Zdrowotnej Med Laser Borzecki Spolka Jawna

    Lublin, 20-406

  • Tomasz Blicharski Lubelskie Centrum Diagnostyczne

    Świdnik, 21-040

  • Centrum Medyczne Pratia Warszawa

    Warsaw, 01-868

  • Medicus Sp z o o

    Wroclaw, 50-224

  • DermMedica Spzoo

    Wroclaw, 51-318

Other trials in Poland

Canada7 sites

  • DermEffects

    London, Ontario, N6H 5L5

  • Lynderm Research Inc

    Markham, Ontario, L3P 1X3

  • Cheema Research Incorporated

    Mississauga, Ontario, L5A 3V4

  • SKDS Research Incorporated

    Newmarket, Ontario, L3Y 5G8

  • Gordon Sussman Clinical Research Incorporated

    North York, Ontario, M3B 3S6

  • JRB Research Incorporated

    Ottawa, Ontario, K1H 7X3

  • Doctor Chih-Ho Hong Medical Incorporated

    Surrey, British Columbia, V3R 6A7

Other trials in Canada

Hungary6 sites

  • Csalogany Orvosi Kozpont

    Budapest, 1027

  • Obudai Egeszsegugyi Centrum Kft

    Budapest, 1036

  • Debreceni Egyetem Kenezy Gyula Egyetemi Korhaz

    Debrecen, 4031

  • CRU Hungary Kft

    Miskolc, 3529

  • Pecsi Tudomanyegyetem Klinikai Kozpont

    Pécs, 7632

  • Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont Altalanos Orvostudomanyi Kar

    Szeged, 6720

Other trials in Hungary

Spain6 sites

  • Hospital General Universitario de Alicante

    Alicante, Valencia, 03010

  • Hospital Universitari Germans Trias i Pujol

    Badalona, Cataluña, 08916

  • Hospital del Mar

    Barcelona, Cataluña, 08003

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, Cataluña, 08041

  • Hospital Universitario de La Princesa

    Madrid, 28006

  • Hospital Universitario Virgen Macarena

    Seville, AndalucÃ-a, 41009

Other trials in Spain

Ukraine6 sites

  • Chernivtsi Regional Skin and Venereal Dispensary

    Chernivtsi, 58002

  • Regional Skin and Venereal Dispensary

    Dnipro, 49074

  • Ivano-Frankivsk Regional Skin and Venereal Dispensary

    Ivano-Frankivsk, 76018

  • Medical clinic Blagomed

    Kyiv, 02000

  • Asclepius

    Uzhhorod, 88000

  • Military Hospital, Military Unit A3309 of the Military Medical Clinical Center

    Zaporizhzhya, 69000

Other trials in Ukraine

Australia5 sites

  • Skin Health Institute

    Carlton, Victoria, 3053

  • Fremantle Dermatology

    Fremantle, Western Australia, 6160

  • The Royal Melbourne Hospital

    Parkville, Victoria, 3050

  • Holdsworth House Medical Practice

    Sydney, New South Wales, 2010

  • Veracity Clinical Research

    Woolloongabba, Queensland, 4102

Other trials in Australia

Czechia5 sites

  • Fakultni nemocnice u sv Anny v Brne

    Brno, 656 91

  • Nemocnice Novy Jicin as

    Nový Jičín, 741 01

  • Fakultni nemocnice Ostrava

    Ostrava-Poruba, 708 52

  • Sanatorium profesora Arenbergera

    Prague, 110 00

  • Nemocnice Na Bulovce

    Prague, 180 81

Other trials in Czechia

Latvia4 sites

  • Riga First Hospital

    Riga, 1001

  • J Kisis

    Riga, 1003

  • Clinic Latvian Dermatology Institute

    Riga, 1011

  • Outpatient Clinic of Ventspils

    Ventspils, 3601

Other trials in Latvia

Estonia3 sites

  • North Estonia Medical Centre

    Tallinn, 13419

  • Clinical Research Centre

    Tartu, 50106

  • Tartu University Hospital

    Tartu, 50417

Other trials in Estonia

Germany3 sites

  • Charité Berlin

    Berlin, 10117

  • Universitätsmedizin Göttingen - Georg-August-Universität

    Göttingen, 37075

  • Medizinische Hochschule Hannover

    Hanover, 30625

Other trials in Germany

United Kingdom3 sites

  • Ninewells Hospital

    Dundee, DD1 9SY

  • Whipps Cross University Hospital

    London, E11 1NR

  • Southampton General Hospital

    Southampton, SO16 6YD

Other trials in United Kingdom

South Korea1 site

  • Hallym University Kangnam Sacred Heart Hospital

    Seoul, 07441

Other trials in South Korea

Switzerland1 site

  • Centre Hospitalier Universitaire Vaudois

    Lausanne, 1011

Other trials in Switzerland

About this study

Official title: A Dose-Ranging, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Tezepelumab Alone or Combined With Topical Corticosteroids in Moderate-to-Severe Atopic Dermatitis

This phase 2b study is designed to evaluate the safety and efficacy of tezepelumab as a monotherapy and explore its efficacy as adjunct therapy in subjects with moderate-to-severe atopic dermatitis (AD).

Read the detailed description

All subjects will receive a subcutaneous (SC) dose of either investigational product or placebo as the first dose on day 1.

Subjects who are determined to be non-responders in Part A will receive tezepelumab SC every 2 weeks (Q2W) following completion of all week 16 study activities. Nonresponders are defined as those subjects who have not achieved at least a 50% improvement in Eczema Area and Severity Index (EASI) at week 16 compared to baseline (day 1).

Safety follow-up is 18 weeks after the end of treatment (EOT) visit (20 weeks after the final dose of investigational product).

Being tested
Tezepelumab, Placebo
Keywords
Atopic Dermatitis, eczema, tezepelumab, dermatology, dermatitis, inflammation, skin, moderate dermatitis, severe dermatitis
Medical subject headings
Dermatitis, Atopic, Eczema, Dermatitis, Inflammation

What participants receive

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

  • TezepelumabDrug

    Also called AMG157

    Solution for injection

  • PlaceboOther

    Placebo solution for injection

Study groups in NCT03809663
Study groupRoleWhat they receive
Part A: PlaceboPlacebo comparatorMatching placebo administered via SC injection Q2W for a maximum of 52 weeks. Participants defined as non-responders (those who do not achieve at least 50% improvement in EASI at Week 16 compared to baseline) will switch to receive tezepelumab 420 mg SC injection Q2W for the remainder of the study beginning with the Week 18 dose.
Receives: Other: Placebo
Part A: Tezepelumab 210 mgExperimentalTezepelumab 210 mg administered via SC injection once every 4 weeks (Q4W) from Week 4 for a maximum of 52 weeks. All participants randomized to tezepelumab will receive 420 mg SC injection as their first dose. Participants will then receive a placebo at Week 2 to maintain blinding. Participants defined as non-responders (those who do not achieve at least 50% improvement in EASI at Week 16 compared to baseline) will switch to receive tezepelumab 420 mg SC injection Q2W for the remainder of the study beginning with the Week 18 dose.
Receives: Drug: Tezepelumab
Part A: Tezepelumab 280 mgExperimentalTezepelumab 280 mg administered via SC injection Q2W from Week 2 for a maximum of 52 weeks. All participants randomized to tezepelumab will receive 420 mg SC injection as their first dose. Participants will then receive their randomized dose of 280 mg Q2W from Week 2. Participants defined as non-responders (those who did not achieve at least 50% improvement in EASI at Week 16 compared to baseline) will switch to receive tezepelumab 420 mg SC injection Q2W for the remainder of the study beginning with the Week 18 dose.
Receives: Drug: Tezepelumab
Part A: Tezepelumab 420 mgExperimentalTezepelumab 420 mg administered via SC injection Q2W for a maximum of 52 weeks.
Receives: Drug: Tezepelumab
Part B: Placebo and Topical Corticosteroids RegimenExperimentalMatching placebo administered via SC injection Q2W with topical corticosteroids (TCS) for a maximum of 52 weeks.
Receives: Drug: Tezepelumab
Part B: Tezepelumab 420 mg and Topical Corticosteroids RegimenExperimentalTezepelumab 420 mg administered via SC injection Q2W with TCS for a maximum of 52 weeks.
Receives: Drug: Tezepelumab

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 (Clear) or 1 (Almost Clear) (IGA 0/1) at Week 16

    The IGA allows investigators to assess overall disease severity at 1 given time point and consists of a 6-point severity scale from clear to severe disease

    • 0 = clear
    • 1 = almost clear
    • 2 = mild disease
    • 3 = moderate disease
    • 4 = severe disease
    • 5 = very severe disease

    The IGA uses clinical characteristics of erythema, infiltration, papulation, oozing, and crusting as guidelines for the overall severity assessment (Breuer et al, 2004).

    Participants who took rescue medication between Day 29 to Week 16 were considered non-responders.

    Measured: Week 16

  2. Number of Participants Who Experienced a 75% Reduction From Baseline in Eczema Area and Severity Index (EASI 75) at Week 16

    The EASI evaluates 4 natural anatomical regions for severity and extent of key disease signs and focuses on key acute and chronic signs of inflammation (ie, erythema, induration/papulation, excoriation, and lichenification).

    A reduction in the EASI score indicates an improvement in severity. Participants who took rescue medication between Day 29 to Week 16 were considered non-responders.

    Measured: Baseline and Week 16

Secondary outcomes (6)

  1. Number of Participants Who Experienced a 50% or 90% Reduction From Baseline in Eczema Area and Severity Index (EASI 50/90) at Week 16

    The EASI evaluates 4 natural anatomical regions for severity and extent of key disease signs and focuses on key acute and chronic signs of inflammation (ie, erythema, induration/papulation, excoriation, and lichenification).

    A reduction in the EASI score indicates an improvement in severity. Participants who took rescue medication between Day 29 to Week 16 were considered non-responders.

    Measured: Baseline and Week 16

  2. Time to Achievement of 50%, 75% or 90% Reduction From Day 1 in Eczema Area and Severity Index (EASI 50/75/90)

    Measured: Day 1 up to End of Study Visit (Week 70)

  3. Change From Baseline in Scoring of Atopic Dermatitis (SCORAD) at Week 16

    The SCORAD is a clinical tool for assessing the severity (ie, extent, intensity) of atopic dermatitis (AD). The tool evaluates the extent and intensity of the AD lesions, along with subjective symptoms (Kunz et al, 1997). The total score ranges from 0 to 103, with higher values indicating more severe disease. A negative change from baseline indicates an improvement in severity of disease.

    Measured: Baseline and Week 16

  4. Change From Baseline in Pruritus Numeric Rating Scale (NRS) at Week 16

    Pruritus was assessed using an NRS (0-10) with 0 = no itch and 10 = worst imaginable itch. A negative change from baseline indicates an improvement in symptoms.

    Measured: Baseline and Week 16

  5. Serum Trough Concentrations of Tezepelumab After Q2W or Q4W Administration

    Switchers were included up to Week 16 and were then excluded from the analysis after switching. All Tezepelumab participants received 420 mg of Tezepelumab on Day 1.

    Measured: Pre-dose on Day 1, Week 2, 4, 12, 16, 24, 32, 40, 48, 50, 52, 58 and 70

  6. Serum Trough Concentrations of Tezepelumab After Switching to 420 mg Q2W Administration After Week 16

    Measured: Pre-dose on Week 24, 32, 40, 48, 50, 52, 58 and 70

Timeline

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

  1. First posted18 Jan 2019
  2. Study start15 Mar 2019
  3. Primary completion12 May 2020
  4. Study completion22 Dec 2020

Why it stopped: Tezepelumab as a monotherapy in atopic dermatitis did not reach the targeted efficacy level pre-established for this patient population.

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
This phase 2b study is designed to evaluate the safety and efficacy of tezepelumab as a monotherapy and explore its efficacy as adjunct therapy in subjects with moderate-to-severe AD. This study consists of Part A (the main study evaluating tezepelumab as a monotherapy) and Part B (a study evaluating tezepelumab as adjunctive therapy when combined with a topical corticosteroid regimen
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
251 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03809663
Sponsor's protocol ID
20170755
Other IDs
2018-001997-52, 2018
Status last verified
Mar 2022
First submitted
10 Jan 2019
Last updated
10 Mar 2022
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Tezepelumab in people with Atopic Dermatitis, run by Amgen at 86 sites in 15 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 9 inclusion and 30 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: stopped early, as of the sponsor's last update on 10 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 86 sites in United States, Japan, Poland, Canada, Hungary and 10 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Mar 2022). 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 (Clear) or 1 (Almost Clear) (IGA 0/1) at Week 16 (time frame: Week 16). The study lists 2 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 NCT03809663.

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 10 Mar 2022.

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