Atopic DermatitisPhase 4NCT06773455

Tralokinumab for Dupilumab Failures

A Phase 4 study testing tralokinumab in people with Atopic Dermatitis, run by Psoriasis Treatment Center of Central New Jersey at 1 site in United States.

Terminated

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

Official record

Search all trials

Trial summary

24-week study of 20 atopic dermatitis patients who have been treated with dupilumab will receive Tralokinumab 600mg at week 0 followed by 300mg Q2W for 24 weeks. 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?: tralokinumab
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 7 participants
Where: 1 siteUnited States
Study dates: 11 Sep 2023to 13 Jan 2026
Phase: Phase 4
Are there results?: None posted in the registry

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 adult ≥ 18 years of age;
All participants must have prior treatment with dupilumab for atopic dermatitis meeting one of the following conditions:
Participants who stopped dupilumab treatment due to non-response, partial response, loss of efficacy must have been previously treated with dupilumab for at least 12 weeks.
Participants who stopped dupilumab treatment due to intolerance or AEs to the drug may enter the study with no required prior length of dupilumab treatment. AE's must be resolved prior to 1st tralokinumab dose.
Females of childbearing potential (FCBP) must have a negative urine pregnancy test at Baseline. FCBP who engage in activity in which conception is possible must use one of the approved contraceptive options: hormonal contraception; intrauterine device (IUD); tubal ligation; or partner's vasectomy; Male or female condom diaphragm with spermicide, cervical cap with spermicide, or contraceptive sponge with spermicide.
Subject is a candidate for systemic therapy.
Subject must be in general good health as judged by the Investigator, based on medical history, physical examination.
Able and willing to give written informed consent prior to performance of any study-related procedures.

Who cannot join

Subjects with previous exposure to tralokinumab.
Known or suspected hypersensitivity to tralokinumab or any of its excipients.
Women of childbearing potential who are pregnant, intend to become pregnant, or are lactating.
Use of tanning beds or phototherapy within 4 weeks of baseline
Use of systemic therapies (systemic steroids, cyclosporine, oral JAK inhibitors etc.) for atopic dermatitis within 4 weeks
Patient non-compliant with Dupixent dosing based on investigator discretion.
Any clinically significant (as determined by the investigator) cardiac, endocrinologic, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic, immunologic disease, or other major disease that is uncontrolled.

Trial locations and contacts

1 site in 1 country.

United States1 site

Psoriasis Treatment Center of New Jersey
East Windsor, New Jersey, 08520

Other trials in United States

About this study

Official title: A Single-Center, Open-Label Study to Evaluate Tralokinumab in Atopic Dermatitis Subjects Who Experienced Inadequate Response on Dupilumab

24-week study of 20 atopic dermatitis patients who have been treated with dupilumab will receive Tralokinumab 600mg at week 0 followed by 300mg Q2W for 24 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
600mg at week 0 followed by 300mg Q2W for 24 weeks

Study groups in NCT06773455
Study group	Role	What they receive
Tralokinumab	Experimental	Not described Receives: Drug: tralokinumab

What is being measured

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

Proportion of subjects achieving IGA 0 or 1 at week 16
Measured: 16 Weeks

Timeline

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

11 Sep 202313 Jan 2026

First posted14 Jan 2025
Study start11 Sep 2023
Primary completion13 Jan 2026
Study completion13 Jan 2026

Why it stopped: Principal Investigator retired

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (5)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 4
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 7 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06773455
Sponsor's protocol ID: ETC05
Status last verified: May 2026
First submitted: 8 Jan 2025
Last updated: 22 May 2026
Results posted: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Wollenberg A, Blauvelt A, Guttman-Yassky E, Worm M, Lynde C, Lacour JP, Spelman L, Katoh N, Saeki H, Poulin Y, Lesiak A, Kircik L, Cho SH, Herranz P, Cork MJ, Peris K, Steffensen LA, Bang B, Kuznetsova A, Jensen TN, Osterdal ML, Simpson EL; ECZTRA 1 and ECZTRA 2 study investigators. Tralokinumab for moderate-to-severe atopic dermatitis: results from two 52-week, randomized, double-blind, multicentre, placebo-controlled phase III trials (ECZTRA 1 and ECZTRA 2). Br J Dermatol. 2021 Mar;184(3):437-449. doi: 10.1111/bjd.19574. Epub 2020 Dec 30.
PubMed 33000465
Vangipuram R, Tyring SK. Dupilumab for Moderate-to-Severe Atopic Dermatitis. Skin Therapy Lett. 2017 Nov;22(6):1-4.
PubMed 29091379
Bieber T. Atopic dermatitis. N Engl J Med. 2008 Apr 3;358(14):1483-94. doi: 10.1056/NEJMra074081. No abstract available.
PubMed 18385500
Akdis CA, Akdis M, Bieber T, Bindslev-Jensen C, Boguniewicz M, Eigenmann P, Hamid Q, Kapp A, Leung DY, Lipozencic J, Luger TA, Muraro A, Novak N, Platts-Mills TA, Rosenwasser L, Scheynius A, Simons FE, Spergel J, Turjanmaa K, Wahn U, Weidinger S, Werfel T, Zuberbier T; European Academy of Allergology and Clinical Immunology/American Academy of Allergy, Asthma and Immunology. Diagnosis and treatment of atopic dermatitis in children and adults: European Academy of Allergology and Clinical Immunology/American Academy of Allergy, Asthma and Immunology/PRACTALL Consensus Report. J Allergy Clin Immunol. 2006 Jul;118(1):152-69. doi: 10.1016/j.jaci.2006.03.045.
PubMed 16815151
Schmitt J, Langan S, Deckert S, Svensson A, von Kobyletzki L, Thomas K, Spuls P; Harmonising Outcome Measures for Atopic Dermatitis (HOME) Initiative. Assessment of clinical signs of atopic dermatitis: a systematic review and recommendation. J Allergy Clin Immunol. 2013 Dec;132(6):1337-47. doi: 10.1016/j.jaci.2013.07.008. Epub 2013 Sep 12.
PubMed 24035157

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

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
RecruitingPhase 2
Cardamom and Topical Roseomonas in Atopic Dermatitis
Atopic Dermatitis, Eczema
RecruitingObservational study
ADBest TREAT Registry
Atopic Dermatitis
RecruitingPhase 2
Effects of Treatments on Atopic Dermatitis
Eczema, Dermatitis
RecruitingObservational study
Natural History and Genetics of Food Allergy and Related Conditions
Food Allergy, Loeys-Dietz Syndrome

All Atopic Dermatitis trials

Study at a glance

From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Single-Center, Open-Label Study to Evaluate Tralokinumab in Atopic Dermatitis Subjects Who Experienced Inadequate Response on Dupilumab
ClinicalTrials.gov ID: NCT06773455
Acronym / sponsor ID: ETC05
Conditions: Atopic Dermatitis
Phase: Phase 4
Study type: Interventional
Recruitment status: TerminatedReason stopped: Principal Investigator retired
Enrolment: 7 participants (actual)
Lead sponsor: Psoriasis Treatment Center of Central New JerseyUniversity, hospital or other
Collaborators: LEO Pharma
Study start: 11 Sep 2023 (actual)
Primary completion: 13 Jan 2026 (actual)
Study completion: 13 Jan 2026 (actual)
First posted: 14 Jan 2025 (actual)
Results: Not posted in the source record

Clinical summary

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

24-week study of 20 atopic dermatitis patients who have been treated with dupilumab will receive Tralokinumab 600mg at week 0 followed by 300mg Q2W for 24 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	Experimental	Drug: tralokinumab

Who may qualify

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

Key inclusion criteria (8 listed)

Male or female adult ≥ 18 years of age;
All participants must have prior treatment with dupilumab for atopic dermatitis meeting one of the following conditions:
Females of childbearing potential (FCBP) must have a negative urine pregnancy test at Baseline. FCBP who engage in activity in which conception is possible must use one of the approved contraceptive options: hormonal contraception; intrauterine device (IUD); tubal ligation; or partner's vasectomy; Male or female condom diaphragm with spermicide, cervical cap with spermicide, or contraceptive sponge with spermicide.
Subject is a candidate for systemic therapy.
Subject must be in general good health as judged by the Investigator, based on medical history, physical examination.

Key exclusion criteria (7 listed)

Subjects with previous exposure to tralokinumab.
Known or suspected hypersensitivity to tralokinumab or any of its excipients.
Women of childbearing potential who are pregnant, intend to become pregnant, or are lactating.
Use of tanning beds or phototherapy within 4 weeks of baseline
Use of systemic therapies (systemic steroids, cyclosporine, oral JAK inhibitors etc.) for atopic dermatitis within 4 weeks

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
tralokinumab600mg at week 0 followed by 300mg Q2W for 24 weeks	Drug	Tralokinumab

Primary outcome

Proportion of subjects achieving IGA 0 or 1 at week 16
Time frame: 16 Weeks

Results and safety

The study was stopped early (reason given: Principal Investigator retired). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
Background: PubMed 33000465Wollenberg A, Blauvelt A, Guttman-Yassky E, Worm M, Lynde C, Lacour JP, Spelman L, Katoh N, Saeki H, Poulin Y, Lesiak A, Kircik L, Cho SH, Herranz P, Cork MJ, Peris K, Steffensen LA, Bang B, Kuznetsova A, Jensen TN, Osterdal ML, Simpson EL; ECZTRA 1 and ECZTRA 2 study investigators. Tralokinumab for moderate-to-severe atopic dermatitis: results from two 52-week, randomized, double-blind, multicentre, placebo-controlled phase III trials (ECZTRA 1 and ECZTRA 2). Br J Dermatol. 2021 Mar;184(3):437-449. doi: 10.1111/bjd.19574. Epub 2020 Dec 30.
Background: PubMed 29091379Vangipuram R, Tyring SK. Dupilumab for Moderate-to-Severe Atopic Dermatitis. Skin Therapy Lett. 2017 Nov;22(6):1-4.
Background: PubMed 18385500Bieber T. Atopic dermatitis. N Engl J Med. 2008 Apr 3;358(14):1483-94. doi: 10.1056/NEJMra074081. No abstract available.
Background: PubMed 16815151Akdis CA, Akdis M, Bieber T, Bindslev-Jensen C, Boguniewicz M, Eigenmann P, Hamid Q, Kapp A, Leung DY, Lipozencic J, Luger TA, Muraro A, Novak N, Platts-Mills TA, Rosenwasser L, Scheynius A, Simons FE, Spergel J, Turjanmaa K, Wahn U, Weidinger S, Werfel T, Zuberbier T; European Academy of Allergology and Clinical Immunology/American Academy of Allergy, Asthma and Immunology. Diagnosis and treatment of atopic dermatitis in children and adults: European Academy of Allergology and Clinical Immunology/American Academy of Allergy, Asthma and Immunology/PRACTALL Consensus Report. J Allergy Clin Immunol. 2006 Jul;118(1):152-69. doi: 10.1016/j.jaci.2006.03.045.
Background: PubMed 24035157Schmitt J, Langan S, Deckert S, Svensson A, von Kobyletzki L, Thomas K, Spuls P; Harmonising Outcome Measures for Atopic Dermatitis (HOME) Initiative. Assessment of clinical signs of atopic dermatitis: a systematic review and recommendation. J Allergy Clin Immunol. 2013 Dec;132(6):1337-47. doi: 10.1016/j.jaci.2013.07.008. Epub 2013 Sep 12.
Individual participant dataSharing planned: No

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
RecruitingPhase 2
Cardamom and Topical Roseomonas in Atopic Dermatitis
Atopic Dermatitis, Eczema
RecruitingObservational study
ADBest TREAT Registry
Atopic Dermatitis
RecruitingPhase 2
Effects of Treatments on Atopic Dermatitis
Eczema, Dermatitis
RecruitingObservational study
Natural History and Genetics of Food Allergy and Related Conditions
Food Allergy, Loeys-Dietz Syndrome

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.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing tralokinumab in people with Atopic Dermatitis, run by Psoriasis Treatment Center of Central New Jersey at 1 site 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 8 inclusion and 7 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 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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

Are results available for this study?

The study was stopped early (reason given: Principal Investigator retired). Results are not available in the source record.

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?

Proportion of subjects achieving IGA 0 or 1 at week 16 (time frame: 16 Weeks). 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 NCT06773455, which also lists 5 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 22 May 2026.