Atopic DermatitisPhase 2D2213C00001NCT02347176

Phase 2 Study to Evaluate the Efficacy and Safety of Tralokinumab in Adults With Atopic Dermatitis

A Phase 2 study testing Tralokinumab Dose 1, Tralokinumab Dose 2 and Tralokinumab Dose 3 in people with Atopic Dermatitis, run by MedImmune LLC at 57 sites in 6 countries.

Completed

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

Official record

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Trial summary

The aim of the study is to evaluate the efficacy and safety of tralokinumab in adults with atopic dermatitis 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?: Tralokinumab Dose 1, Tralokinumab Dose 2 and Tralokinumab Dose 3
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 204 participants
Where: 57 sitesin 6 countries
Study dates: 23 Jan 2015to 5 Feb 2016
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

Physician diagnosis of atopic dermatitis for greater than (>) 1 year
Atopic dermatitis involvement of greater than or equal to (>=) 10 percent (%) body surface area
EASI score of >= 12
SCORAD of >= 25
IGA score of >= 3
Effective birth control in line with protocol details

Who cannot join

History of anaphylaxis following any biologic therapy
Hepatitis B, C or human immunodeficiency virus
Pregnant or breastfeeding
History of cancer
Previous receipt of tralokinumab

Trial locations and contacts

57 sites in 6 countries.

Country

City, postcode or hospital

57 sites in 6 countries

United States24 sites

Research Site
Berlin, New Jersey, 08009
Research Site
Charleston, South Carolina, 29414
Research Site
Clearwater, Florida, 33759
Research Site
Fremont, California, 94538
Research Site
Fullerton, California, 92835
Research Site
Houston, Texas, 77004
Research Site
Houston, Texas, 77056
Research Site
Los Angeles, California, 90045
Research Site
Miami, Florida, 33144
Research Site
New York, New York, 10029
Research Site
Norfolk, Virginia, 23507
Research Site
Oceanside, California, 92056
Research Site
Pflugerville, Texas, 78660
Research Site
Phoenix, Arizona, 85018
Research Site
Portland, Oregon, 97241
Research Site
Rancho Santa Margarita, California, 92688
Research Site
Rochester, New York, 14625
Research Site
Rogers, Arkansas, 72758
Research Site
San Antonio, Texas, 78218
Research Site
San Antonio, Texas, 78229
Research Site
Santa Monica, California, 90404
Research Site
Verona, New Jersey, 07044
Research Site
Warren, Michigan, 48088
Research Site
Worcester, Massachusetts, 01605

Other trials in United States

Germany10 sites

Research Site
Berlin, 10117
Research Site
Bochum, 44803
Research Site
Dresden, 01307
Research Site
Dülmen, 48249
Research Site
Frankfurt am Main, 60590
Research Site
Hanover, 30625
Research Site
München, 80337
Research Site
Münster, 48149
Research Site
Stuttgart-Weilimdorf, 70499
Research Site
Wuppertal, 42287

Other trials in Germany

Canada6 sites

Research Site
Courtice, Ontario, L1E 3C3
Research Site
Markham, Ontario, L3P1X2
Research Site
Peterborough, Ontario, K9J 5K2
Research Site
Surrey, British Columbia, V3V 0C6
Research Site
Waterloo, Ontario, N2J 1C4
Research Site
Windsor, Ontario, N8W 5L7

Other trials in Canada

Japan6 sites

Research Site
Nakano, 164-0001
Research Site
Shibuya-ku, 150-0034
Research Site
Shinjuku-ku, 160-0004
Research Site
Shinjuku-ku, 160-0023
Research Site
Shinjuku-ku, 169-0075
Research Site
Yokohama, 220-0073

Other trials in Japan

Poland6 sites

Research Site
Katowice, 40-611
Research Site
Lodz, 90-436
Research Site
Szczecin, 70-332
Research Site
Warsaw, 04-141
Research Site
Wroclaw, 50-368
Research Site
Wroclaw, 51-318

Other trials in Poland

Australia5 sites

Research Site
East Melbourne, 3002
Research Site
Kogarah, 02217
Research Site
Liverpool, 2170
Research Site
Sydney, 02010
Research Site
Woolloongabba, 04102

Other trials in Australia

About this study

Official title: A Phase 2b, Randomized, Double-blinded, Placebo-controlled, Dose-ranging Study to Evaluate the Efficacy and Safety of Tralokinumab in Adult Subjects With Moderate-to-Severe Atopic Dermatitis

The aim of the study is to evaluate the efficacy and safety of tralokinumab in adults with atopic dermatitis

Conditions: Atopic Dermatitis
Being tested: Placebo, Tralokinumab Dose 1, Tralokinumab Dose 2, Tralokinumab Dose 3
Medical subject headings: Dermatitis, Atopic

What participants receive

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

PlaceboOther
Subcutaneous injection with placebo
Tralokinumab Dose 1Biological
Subcutaneous injection with tralokinumab
Tralokinumab Dose 2Biological
Subcutaneous injection with tralokinumab
Tralokinumab Dose 3Biological
Subcutaneous injection with tralokinumab

Study groups in NCT02347176
Study group	Role	What they receive
Placebo	Placebo comparator	Placebo matched to Tralokinumab will be administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks. Receives: Other: Placebo
Tralokinumab Dose 1	Experimental	Tralokinumab Dose 1 will be administered subcutaneously once every 2 Weeks (Q2W) for 12 weeks. Receives: Biological: Tralokinumab Dose 1
Tralokinumab Dose 2	Experimental	Tralokinumab Dose 2 will be administered subcutaneously once every 2 Weeks (Q2W) for 12 weeks. Receives: Biological: Tralokinumab Dose 2
Tralokinumab Dose 3	Experimental	Tralokinumab Dose 3 will be administered subcutaneously once every 2 Weeks (Q2W) for 12 weeks. Receives: Biological: Tralokinumab Dose 3

What is being measured

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

Absolute Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Week 12
EASI evaluates 4 natural anatomical regions for severity and extent of key disease signs and focuses on the key acute and chronic signs of inflammation (erythema, induration/papulation, excoriation, and lichenification). The maximum total score is 72, with higher values indicating more severe disease. The data presented here is Adjusted mean change after excluding the data from participants who took prohibited medications.
Measured: Baseline (Day 1) and Week 12
Percentage of Participants Achieving Investigator's Global Assessment (IGA) Response of 0 (Clear) or 1 (Almost Clear) and at Least a 2-Grade Reduction From Baseline at Week 12
The IGA allows investigators to assess overall disease severity at one given time point and consists of a 6-point severity scale from clear to very severe disease (0 = clear, 1 = almost clear, 2 = mild disease, 3 = moderate disease, 4 = severe disease, and 5 = very severe disease). A participant has IGA response if they achieve a score of 0 (clear) or 1 (almost clear) and at least a 2-grade reduction from baseline.
Measured: Week 12

Secondary outcomes (8)

Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
An adverse event (AE) present at baseline that worsened in intensity after administration of investigational product or events absent at baseline that emerged after administration of study drug until Week 22. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening situation (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect in the offspring of a participant who received Tralokinumab. Treatment-emergent adverse events between administration of investigational product and Week 22 that were absent before treatment or that worsened relative to pre-treatment state.
Measured: From Study Drug Administration (Day 1) to Week 22
Number of Participants With Vital Signs and Physical Examination Abnormalities Reported as Treatment Emergent Adverse Events
Vital sign parameters included blood pressure, temperature, pulse rate, and respiratory rate. TEAEs were present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug until Week 22.
Measured: From Study Drug Administration (Day 1) to Week 22
Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment Emergent Adverse Events
An abnormal laboratory finding which required an action or intervention by the investigator, or a finding judged by the investigator to represent a change beyond the range of normal physiologic fluctuation were reported as an adverse event. Treatment-emergent adverse events between administration of investigational product and Week 22 that were absent before treatment or that worsened relative to pre-treatment state. Laboratory evaluations (haematology, serum chemistry and urinalysis) of blood and urine samples were performed.
Measured: From Study Drug Administration (Day 1) to Week 22
Number of Participants With Electrocardiogram (ECG) Abnormalities Reported as Treatment Emergent Adverse Events
AEs observed in participants with clinically significant ECG abnormalities were assessed. ECG parameters included heart rate, RR, PR, QRS and QT intervals. Treatment-emergent adverse events between administration of investigational product and Week 22 that were absent before treatment or that worsened relative to pre-treatment state.
Measured: From Study Drug Administration (Day 1) to Week 22
Adjusted Percentage of Participants Achieving 50 Percent (%) Reduction From Baseline in Eczema Area and Severity Index (EASI) at Week 12
EASI50 responder is defined as a participant who achieves at least a 50% reduction in EASI score from baseline. Data from participants who took prohibited medications were excluded from this analysis and a last observation carried forward (LOCF) analysis was used.
Measured: Week 12
Absolute Change From Baseline in Scoring of Atopic Dermatitis (SCORAD) at Week 12
The SCORAD is a clinical tool for assessing the severity (that is, extent, intensity) of atopic dermatitis (AD). The tool evaluates the extent and intensity of the AD lesions, along with participant symptoms. The maximum total score is 103, with higher values indicating more severe disease. The data presented here is Adjusted mean change after excluding the data from participants who took prohibited medications.
Measured: Baseline (Day 1) and Week 12
Adjusted Percentage of Participants Achieving 50 Percent (%) Reduction From Baseline in SCORAD at Week 12
SCORAD 50 responder is defined as a participant who achieves at least a 50% reduction in SCORAD score from baseline. Data from participants who took prohibited medications were excluded from this analysis and a LOCF analysis was used.
Measured: Week 12
Change From Baseline in Pruritus Numeric Rating Scale (NRS) (7-day Mean Score) at Week 12
Pruritus assessed using an NRS (0 - 10) with 0= no itch and 10= worst imaginable itch. Daily pruritus assessments were summarized as weekly peak score and a change from baseline in weekly peak score was calculated. The data presented here is Adjusted mean change after excluding the data from participants who took prohibited medications.
Measured: Baseline (Day 1) and Week 12

Timeline

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

23 Jan 20155 Feb 2016

First posted27 Jan 2015 (estimated)
Study start23 Jan 2015
Primary completion27 Nov 2015
Study completion5 Feb 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 (2)Papers the sponsor has linked to this study.
Other trials for Atopic DermatitisStudies 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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 204 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02347176
Sponsor's protocol ID: D2213C00001
Acronym: D2213C00001
Status last verified: Apr 2018
First submitted: 5 Jan 2015
Last updated: 23 May 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Silverberg JI, Guttman-Yassky E, Gooderham M, Worm M, Rippon S, O'Quinn S, van der Merwe R, Kragh N, Kurbasic A, Wollenberg A. Health-related quality of life with tralokinumab in moderate-to-severe atopic dermatitis: A phase 2b randomized study. Ann Allergy Asthma Immunol. 2021 May;126(5):576-583.e4. doi: 10.1016/j.anai.2020.12.004. Epub 2020 Dec 15.
PubMed 33333295
Wollenberg A, Howell MD, Guttman-Yassky E, Silverberg JI, Kell C, Ranade K, Moate R, van der Merwe R. Treatment of atopic dermatitis with tralokinumab, an anti-IL-13 mAb. J Allergy Clin Immunol. 2019 Jan;143(1):135-141. doi: 10.1016/j.jaci.2018.05.029. Epub 2018 Jun 12.
PubMed 29906525

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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RecruitingPhase 2
Cardamom and Topical Roseomonas in Atopic Dermatitis
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All Atopic Dermatitis trials

Study at a glance

From the registry record, last updated by the sponsor on 23 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2b, Randomized, Double-blinded, Placebo-controlled, Dose-ranging Study to Evaluate the Efficacy and Safety of Tralokinumab in Adult Subjects With Moderate-to-Severe Atopic Dermatitis
ClinicalTrials.gov ID: NCT02347176
Acronym / sponsor ID: D2213C00001 / D2213C00001
Conditions: Atopic Dermatitis
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 204 participants (actual)
Lead sponsor: MedImmune LLCIndustry (pharma, biotech, devices)
Study start: 23 Jan 2015 (actual)
Primary completion: 27 Nov 2015 (actual)
Study completion: 5 Feb 2016 (actual)
First posted: 27 Jan 2015 (estimated)
Results: Posted 7 Jun 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The aim of the study is to evaluate the efficacy and safety of tralokinumab in adults with atopic dermatitis

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Placebo	Placebo comparator	Other: PlaceboPlacebo matched to Tralokinumab will be administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks.
Tralokinumab Dose 1	Experimental	Biological: Tralokinumab Dose 1Tralokinumab Dose 1 will be administered subcutaneously once every 2 Weeks (Q2W) for 12 weeks.
Tralokinumab Dose 2	Experimental	Biological: Tralokinumab Dose 2Tralokinumab Dose 2 will be administered subcutaneously once every 2 Weeks (Q2W) for 12 weeks.
Tralokinumab Dose 3	Experimental	Biological: Tralokinumab Dose 3Tralokinumab Dose 3 will be administered subcutaneously once every 2 Weeks (Q2W) for 12 weeks.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Physician diagnosis of atopic dermatitis for greater than (>) 1 year
Atopic dermatitis involvement of greater than or equal to (>=) 10 percent (%) body surface area
EASI score of >= 12
SCORAD of >= 25
IGA score of >= 3

Key exclusion criteria (5 listed)

History of anaphylaxis following any biologic therapy
Hepatitis B, C or human immunodeficiency virus
Pregnant or breastfeeding
History of cancer
Previous receipt of tralokinumab

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
PlaceboSubcutaneous injection with placebo	Other	Placebo
Tralokinumab Dose 1Subcutaneous injection with tralokinumab	Biological	Tralokinumab Dose 1
Tralokinumab Dose 2Subcutaneous injection with tralokinumab	Biological	Tralokinumab Dose 2
Tralokinumab Dose 3Subcutaneous injection with tralokinumab	Biological	Tralokinumab Dose 3

Primary outcome

Absolute Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Week 12
Time frame: Baseline (Day 1) and Week 12
EASI evaluates 4 natural anatomical regions for severity and extent of key disease signs and focuses on the key acute and chronic signs of inflammation (erythema, induration/papulation, excoriation, and lichenification). The maximum total score is 72, with higher values indicating more severe disease. The data presented here is Adjusted mean change after excluding the data from participants who took prohibited medications.
Percentage of Participants Achieving Investigator's Global Assessment (IGA) Response of 0 (Clear) or 1 (Almost Clear) and at Least a 2-Grade Reduction From Baseline at Week 12
Time frame: Week 12
The IGA allows investigators to assess overall disease severity at one given time point and consists of a 6-point severity scale from clear to very severe disease (0 = clear, 1 = almost clear, 2 = mild disease, 3 = moderate disease, 4 = severe disease, and 5 = very severe disease). A participant has IGA response if they achieve a score of 0 (clear) or 1 (almost clear) and at least a 2-grade reduction from baseline.

8 secondary outcomes

Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
Time frame: From Study Drug Administration (Day 1) to Week 22
Number of Participants With Vital Signs and Physical Examination Abnormalities Reported as Treatment Emergent Adverse Events
Time frame: From Study Drug Administration (Day 1) to Week 22
Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment Emergent Adverse Events
Time frame: From Study Drug Administration (Day 1) to Week 22
Number of Participants With Electrocardiogram (ECG) Abnormalities Reported as Treatment Emergent Adverse Events
Time frame: From Study Drug Administration (Day 1) to Week 22
Adjusted Percentage of Participants Achieving 50 Percent (%) Reduction From Baseline in Eczema Area and Severity Index (EASI) at Week 12
Time frame: Week 12
Absolute Change From Baseline in Scoring of Atopic Dermatitis (SCORAD) at Week 12
Time frame: Baseline (Day 1) and Week 12
Adjusted Percentage of Participants Achieving 50 Percent (%) Reduction From Baseline in SCORAD at Week 12
Time frame: Week 12
Change From Baseline in Pruritus Numeric Rating Scale (NRS) (7-day Mean Score) at Week 12
Time frame: Baseline (Day 1) and Week 12

Results and safety

Results posted to the registry on 7 Jun 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	51	39
Tralokinumab Dose 1	50	40
Tralokinumab Dose 2	51	43
Tralokinumab Dose 3	52	48

Primary outcome: Absolute Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Week 12

Time frame: Baseline (Day 1) and Week 12. Mean (Standard Error). Unit: units on a scale

Measure	Placebo n = 51	Tralokinumab Dose 1 n = 50	Tralokinumab Dose 2 n = 51	Tralokinumab Dose 3 n = 52
Value	-10.78 (1.398)	-13.67 (1.386)	-15.14 (1.361)	-15.72 (1.334)

Placebo vs Tralokinumab Dose 1: Adjusted Mean Difference: -2.89 (95% CI -6.78 to 0.99), p = 0.143, Mixed Model Repeated Measures Analysis
Placebo vs Tralokinumab Dose 2: Adjusted Mean Difference: -4.36 (95% CI -8.22 to -0.51), p = 0.027, Mixed Model Repeated Measures Analysis
Placebo vs Tralokinumab Dose 3: Adjusted Mean Difference: -4.94 (95% CI -8.76 to -1.13), p = 0.011, Mixed Model Repeated Measures Analysis

Population analysed: The intent-to-treat (ITT) population included all randomized and treated participants, grouped according to assigned treatment. Here, the category "Number Analyzed" is number of participants analyzed for this outcome measure.

Primary outcome: Percentage of Participants Achieving Investigator's Global Assessment (IGA) Response of 0 (Clear) or 1 (Almost Clear) and at Least a 2-Grade Reduction From Baseline at Week 12

Time frame: Week 12. Number. Unit: Percentage of participants

Measure	Placebo n = 51	Tralokinumab Dose 1 n = 50	Tralokinumab Dose 2 n = 51	Tralokinumab Dose 3 n = 52
Value	11.8	11.6	19.5	26.7

Placebo vs Tralokinumab Dose 1: Odds Ratio (OR): 0.98 (95% CI 0.29 to 3.32), p = 0.974, Regression, Logistic
Placebo vs Tralokinumab Dose 2: Odds Ratio (OR): 1.85 (95% CI 0.61 to 5.65), p = 0.281, Regression, Logistic
Placebo vs Tralokinumab Dose 3: Odds Ratio (OR): 2.83 (95% CI 0.95 to 8.37), p = 0.061, Regression, Logistic

Population analysed: The ITT population included all randomized and treated participants, grouped according to assigned treatment. Here, the category "Number Analyzed" is number of participants analyzed for this outcome measure.

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: From Study Drug Administration (Day 1) to Week 22. Other adverse events reported at 3% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	1 of 51 (2%)	15 of 51 (29.4%)	0 of 51
Tralokinumab Dose 1	3 of 50 (6%)	20 of 50 (40%)	1 of 50
Tralokinumab Dose 2	2 of 51 (3.9%)	21 of 51 (41.2%)	0 of 51
Tralokinumab Dose 3	0 of 52 (0%)	22 of 52 (42.3%)	0 of 52

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 33333295Silverberg JI, Guttman-Yassky E, Gooderham M, Worm M, Rippon S, O'Quinn S, van der Merwe R, Kragh N, Kurbasic A, Wollenberg A. Health-related quality of life with tralokinumab in moderate-to-severe atopic dermatitis: A phase 2b randomized study. Ann Allergy Asthma Immunol. 2021 May;126(5):576-583.e4. doi: 10.1016/j.anai.2020.12.004. Epub 2020 Dec 15.
Derived from this study: PubMed 29906525Wollenberg A, Howell MD, Guttman-Yassky E, Silverberg JI, Kell C, Ranade K, Moate R, van der Merwe R. Treatment of atopic dermatitis with tralokinumab, an anti-IL-13 mAb. J Allergy Clin Immunol. 2019 Jan;143(1):135-141. doi: 10.1016/j.jaci.2018.05.029. Epub 2018 Jun 12.

Related trials for Atopic Dermatitis

RecruitingPhase 1
Evaluating the Safety and Tolerability of Baricitinib in Patients With Job Syndrome With Lupus-Like Disease and/or Atopic Dermatitis
Hyper IgE Syndrome From STAT3 Mutation, Job s Syndrome
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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.

The record lists no contact. Use the official record to reach the sponsor.

57 sites in 6 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Tralokinumab Dose 1, Tralokinumab Dose 2 and Tralokinumab Dose 3 in people with Atopic Dermatitis, run by MedImmune LLC at 57 sites in 6 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 6 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 23 May 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 57 sites in United States, Germany, Canada, Japan, Poland and 1 more country. 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 7 Jun 2017). 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?

Absolute Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Week 12 (time frame: Baseline (Day 1) and Week 12). 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 NCT02347176, which also lists 2 linked publications.

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 23 May 2018.