Atopic DermatitisPhase 3INJECZTRANCT05194540
Efficacy and Safety of Tralokinumab Administered by an Autoinjector in Adults and Adolescents With Moderate to Severe Atopic Dermatitis (INJECZTRA)
A Phase 3 study testing Tralokinumab in people with Atopic Dermatitis, run by LEO Pharma at 29 sites in United States.
Trial summary
The purpose of this trial is to evaluate the efficacy and safety of tralokinumab administered as subcutaneous (SC) injection by an autoinjector in adults and adolescents (age 12 to 17 years) with moderate-to-severe atopic dermatitis (AD). Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Tralokinumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 29 sitesUnited States
- Study dates
- 13 Jan 2022to 21 Jun 2023
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age 12 years and above.
- Subject able and willing to self-administer tralokinumab with Device A.
- Diagnosis of AD as defined by the Hanifin and Rajka (1980) criteria for AD.
- History of AD for ≥1 year.
- A recent history (within 1 year before the screening visit) of inadequate response to treatment with topical medication or for whom topical treatments are otherwise medically inadvisable.
- AD involvement of ≥10% body surface area at screening and baseline.
Show all 9Show fewer
- An EASI score of ≥12 at screening and ≥16 at baseline.
- An IGA score of ≥3 at screening and at baseline.
- Applied a stable dose of emollient twice daily (or more, as needed) for at least 14 days before baseline.
Who cannot join
- Active dermatologic conditions that may confound the diagnosis of AD or would interfere with assessment of treatment.
- Use of tanning beds or phototherapy within 4 weeks prior to baseline.
- Treatment with systemic immunosuppressive/immunomodulating drugs and/or systemic corticosteroids within 4 weeks prior to baseline.
- Treatment with topical corticosteroids, topical calcineurin inhibitors, topical phosphodiesterase 4 inhibitors, or topical Janus kinase inhibitors within 2 weeks prior to baseline.
- Receipt of any marketed biological therapy (i.e. immunoglobulin, anti immunoglobulin E) including dupilumab or investigational biologic agents 3 to 6 months prior to baseline.
- Active skin infections within 1 week prior to baseline.
Show all 10Show fewer
- Clinically significant infection within 4 weeks prior to baseline.
- A helminth parasitic infection within 6 months prior to the date informed consent is obtained.
- Tuberculosis requiring treatment within 12 months prior to screening.
- Known primary immunodeficiency disorder.
Trial locations and contacts
29 sites in 1 country.
29 sites in 1 country
United States29 sites
LEO Pharma Investigator
Bangor, Maine, 04401
LEO Pharma Investigator
Bexley, Ohio, 43209
LEO Pharma Investigator
Birmingham, Alabama, 35205
LEO Pharma Investigator
Birmingham, Alabama, 35209
LEO Pharma Investigator
Centennial, Colorado, 80111
LEO Pharma Investigator
Cortland, New York, 13045
LEO Pharma Investigator
Dallas, Texas, 75225
LEO Pharma Investigator
Detroit, Michigan, 48202
LEO Pharma Investigator
Farmington, Connecticut, 06032
LEO Pharma Investigator
Fort Smith, Arkansas, 72916
LEO Pharma Investigator
Fountain Valley, California, 92708
LEO Pharma Investigator
Fremont, California, 94538
LEO Pharma Investigator
Frisco, Texas, 75034
LEO Pharma Investigational Site
Hialeah, Florida, 33012
LEO Pharma Investigator
Horseheads, New York, 14845
LEO Pharma Investigational Site
Inglewood, California, 90301
LEO Pharma Investigator
Libertyville, Illinois, 60048
LEO Pharma Investigator
Los Angeles, California, 90025
LEO Pharma Investigator
Overland Park, Kansas, 66210
LEO Pharma Investigator
Portland, Oregon, 97210
LEO Pharma Investigator
Portsmouth, New Hampshire, 03801
LEO Pharma Investigator
San Antonio, Texas, 78218
LEO Pharma Investigator
San Diego, California, 92103
LEO Pharma Investigator
San Diego, California, 92130
LEO Pharma Investigator
Sanford, Florida, 32771
LEO Pharma Investigator
Santa Ana, California, 92701
LEO Pharma Investigator
Toledo, Ohio, 43617
LEO Pharma Investigator
Tulsa, Oklahoma, 74136
LEO Pharma Investigator
Webster, Texas, 77598
About this study
Official title: An Open-label, Single-arm, Phase 3 Trial to Evaluate the Efficacy and Safety of Tralokinumab Administered by an Autoinjector in Subjects With Moderate-to-severe Atopic Dermatitis
The purpose of this trial is to evaluate the efficacy and safety of tralokinumab administered as subcutaneous (SC) injection by an autoinjector in adults and adolescents (age 12 to 17 years) with moderate-to-severe atopic dermatitis (AD).
Read the detailed description
This is a single-arm, phase 3 trial designed to evaluate the efficacy and safety of tralokinumab when administered by an autoinjector in adults and adolescent subjects with moderate-to-severe AD. At baseline, the subjects will receive an initial SC dose of 600 mg tralokinumab. For the rest of the treatment period, all subjects will self-administer a dose of 300 mg tralokinumab every other week for 14 weeks.
- Conditions
- Atopic Dermatitis
- Being tested
- Tralokinumab
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TralokinumabDrug
Tralokinumab is a human recombinant monoclonal antibody of immunoglobulin G4 (IgG4) subclass that specifically binds to human interleukin-13 (IL-13) and blocks interaction with the IL-13 receptors. It is presented as a liquid formulation for subcutaneous administration
| Study group | Role | What they receive |
|---|---|---|
| Tralokinumab subcutaneous dosing by an autoinjector | Experimental | An initial SC dose of 600 mg tralokinumab at baseline followed by self-administration of a 300 mg dose of tralokinumab every other week for 14 weeks. Receives: Drug: Tralokinumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Week 16
IGA is an instrument used in clinical trials to rate the severity of the participant's global AD and is based on a 5-point scale ranging from 0 (clear) to 4 (severe)
Measured: At Week 16
At Least 75% Reduction in Eczema Area and Severity Index (EASI75) at Week 16
Eczema Area and Severity Index (EASI) is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. EASI is a composite index with scores ranging from 0 to 72, where higher values indicate a more severe or more extensive condition
Measured: At Week 16
Secondary outcomes (2)
Number of Treatment-emergent Adverse Events (AEs) From Baseline to Week 16
An AE will be considered treatment emergent if it started after the first injection of trial drug
Measured: From Week 0 to Week 16
Presence of Treatment-emergent Anti-drug Antibodies (ADA) From Baseline to Week 16
Serum samples for determination of presence or absence of ADA will be analysed using a validated bioanalytical method
Measured: From Week 0 to Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2022
- Study start13 Jan 2022
- Primary completion6 Jun 2023
- Study completion21 Jun 2023
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 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- LEO Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Expert, Study director, LEO Pharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05194540
- Sponsor's protocol ID
- LP0162-1338
- Other IDs
- U1111-1283-2072
- Acronym
- INJECZTRA
- Status last verified
- Jun 2024
- First submitted
- 4 Jan 2022
- Last updated
- 11 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Soung J, Laquer V, Zirwas M, van Iperen P, Stinson JC, Albertsen KL, Stein Gold L. The Tralokinumab Pre-Filled Pen Improved Atopic Dermatitis Signs and Symptoms and Was Well Tolerated in Adults and Adolescents with Moderate-to-Severe Atopic Dermatitis: A 16-Week, Open-Label, Single-Arm Phase 3 Study (INJECZTRA). Dermatol Ther (Heidelb). 2025 Sep;15(9):2631-2644. doi: 10.1007/s13555-025-01490-3. Epub 2025 Jul 18.
PubMed 40681936
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Single-arm, Phase 3 Trial to Evaluate the Efficacy and Safety of Tralokinumab Administered by an Autoinjector in Subjects With Moderate-to-severe Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT05194540
- Acronym / sponsor ID
- INJECZTRA / LP0162-1338
- Conditions
- Atopic Dermatitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- LEO PharmaIndustry (pharma, biotech, devices)
- Study start
- 13 Jan 2022 (actual)
- Primary completion
- 6 Jun 2023 (actual)
- Study completion
- 21 Jun 2023 (actual)
- First posted
- 18 Jan 2022 (actual)
- Results
- Posted 20 Jun 2024
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 trial is to evaluate the efficacy and safety of tralokinumab administered as subcutaneous (SC) injection by an autoinjector in adults and adolescents (age 12 to 17 years) with moderate-to-severe atopic dermatitis (AD).
Detailed description
This is a single-arm, phase 3 trial designed to evaluate the efficacy and safety of tralokinumab when administered by an autoinjector in adults and adolescent subjects with moderate-to-severe AD. At baseline, the subjects will receive an initial SC dose of 600 mg tralokinumab. For the rest of the treatment period, all subjects will self-administer a dose of 300 mg tralokinumab every other week for 14 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tralokinumab subcutaneous dosing by an autoinjector | Experimental | Drug: TralokinumabAn initial SC dose of 600 mg tralokinumab at baseline followed by self-administration of a 300 mg dose of tralokinumab every other week for 14 weeks. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- Age 12 years and above.
- Subject able and willing to self-administer tralokinumab with Device A.
- Diagnosis of AD as defined by the Hanifin and Rajka (1980) criteria for AD.
- History of AD for ≥1 year.
- A recent history (within 1 year before the screening visit) of inadequate response to treatment with topical medication or for whom topical treatments are otherwise medically inadvisable.
Key exclusion criteria (10 listed)
- Active dermatologic conditions that may confound the diagnosis of AD or would interfere with assessment of treatment.
- Use of tanning beds or phototherapy within 4 weeks prior to baseline.
- Treatment with systemic immunosuppressive/immunomodulating drugs and/or systemic corticosteroids within 4 weeks prior to baseline.
- Treatment with topical corticosteroids, topical calcineurin inhibitors, topical phosphodiesterase 4 inhibitors, or topical Janus kinase inhibitors within 2 weeks prior to baseline.
- Receipt of any marketed biological therapy (i.e. immunoglobulin, anti immunoglobulin E) including dupilumab or investigational biologic agents 3 to 6 months prior to baseline.
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 |
|---|---|---|
| TralokinumabTralokinumab is a human recombinant monoclonal antibody of immunoglobulin G4 (IgG4) subclass that specifically binds to human interleukin-13 (IL-13) and blocks interaction with the IL-13 receptors. It is presented as a liquid formulation for subcutaneous administration | Drug | Tralokinumab subcutaneous dosing by an autoinjector |
Primary outcome
Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Week 16
Time frame: At Week 16
IGA is an instrument used in clinical trials to rate the severity of the participant's global AD and is based on a 5-point scale ranging from 0 (clear) to 4 (severe)
At Least 75% Reduction in Eczema Area and Severity Index (EASI75) at Week 16
Time frame: At Week 16
Eczema Area and Severity Index (EASI) is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. EASI is a composite index with scores ranging from 0 to 72, where higher values indicate a more severe or more extensive condition
2 secondary outcomes
Number of Treatment-emergent Adverse Events (AEs) From Baseline to Week 16
Time frame: From Week 0 to Week 16
Presence of Treatment-emergent Anti-drug Antibodies (ADA) From Baseline to Week 16
Time frame: From Week 0 to Week 16
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40681936Soung J, Laquer V, Zirwas M, van Iperen P, Stinson JC, Albertsen KL, Stein Gold L. The Tralokinumab Pre-Filled Pen Improved Atopic Dermatitis Signs and Symptoms and Was Well Tolerated in Adults and Adolescents with Moderate-to-Severe Atopic Dermatitis: A 16-Week, Open-Label, Single-Arm Phase 3 Study (INJECZTRA). Dermatol Ther (Heidelb). 2025 Sep;15(9):2631-2644. doi: 10.1007/s13555-025-01490-3. Epub 2025 Jul 18.
- Individual participant dataSharing planned: No
Related trials for Atopic Dermatitis
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
RecruitingObservational study
Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
Cutaneous T-cell Lymphoma, Sezary Syndrome
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingPhase 1
A Study of HSK60002 Tablets in Participants With Moderate-to-Severe Atopic Dermatitis
Dermatitis Atopic
RecruitingPhase 3
A Study to Learn About the Study Medicine Called Tilrekimig in People With Moderate-to Severe Eczema
Atopic Dermatitis
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.
Medical Expert study director
LEO Pharma
29 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tralokinumab in people with Atopic Dermatitis, run by LEO Pharma at 29 sites in United States.
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 10 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 11 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in 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. 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 20 Jun 2024). 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?
Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Week 16 (time frame: At 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 NCT05194540, 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 11 Mar 2025.