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Atopic DermatitisPhase 2TraSkiNCT04556461

Effects of Tralokinumab Treatment of Atopic Dermatitis on Skin Barrier Function

A Phase 2 study testing Tralokinumab in people with Atopic Dermatitis, run by Prof. Dr. Stephan Weidinger at 1 site in Germany.

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

Effects of tralokinumab treatment of atopic dermatitis on skin barrier function. 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
16 participants
Where
1 siteGermany
Study dates
28 Sep 2020to 31 Mar 2023
Phase
Phase 2
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

  • Written informed consent obtained from the subject prior to performing any protocol-related procedures, including screening evaluations
  • Age ≥ 18 years at time of study entry.
  • Diagnosis of chronic atopic dermatitis for at least 1 year prior to enrollment based on American Academy Criteria
  • Subjects who have a recent history (within 1 year before the screening visit) of inadequate response to treatment with topical medications. Inadequate response is defined as failure to achieve and maintain remission or a low disease activity state (comparable to IGA 0=clear to 2=mild) despite treatment with a daily regimen of TCS of medium to higher potency (±TCI as appropriate), applied for at least 28 days or for the maximum duration recommended by the product prescribing information (e.g. 14 days for super-potent TCS), whichever is shorter. Subjects with documented systemic treatment for AD in the past year are also considered as inadequate responders to topical treatments and are potentially eligible for treatment with Tralokinumab after appropriate washout.
  • Eczema Area and Severity Index (EASI) score ≥12 at screening (Week0 minus 7d) and baseline visit (Week0)
  • Investigator Global Assessment (IGA) ≥3 at screening and baseline visit
Show all 14Show fewer
  • Female patients with reproductive potential must have a negative urine or serum pregnancy test within 7 days prior to start of trial.
  • Female participants who are not capable of bearing children or who use a method of contraception that is medically approved by the health authority of the respective country at screening
  • This includes:
  • A woman who is not capable of bearing a child is defined as follows: post-menopausal (12 months natural (spontaneous) amenorrhea or 6 months spontaneous amenorrhea with serum-FSH-values (follicle-stimulating hormone) of >40 mIU/mL); 6 weeks after a bilateral ovariectomy with or without hysterectomy or sterilization by means of tubal ligation
  • A woman capable of bearing child is defined as follows: a woman who is physiologically capable of becoming pregnant, including women whose occupation, lifestyle or sexual orientation exclude sexual intercourse with a male partner and women whose partners have been sterilized by vasectomy or other measures.
  • Medically-approved methods of contraception can include the following: hormonal contraceptives or, intrauterine device and double barrier method. Acceptable preventive measures can include total abstinence at the discretion of the investigator, in cases where compliance is ensured because of the study participant's age, occupation, lifestyle or sexual orientation. Periodical abstinence (e.g. calendar, ovulation, symptothermal methods or abstinence until the 4th day after the ovulation) as well as coitus interruptus are not acceptable methods of contraception.
  • A reliable method of contraception (CTFG guideline) must be used for the entire duration of the study.
  • Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.

Who cannot join

  • Subject is unable to provide written informed consent or comply with the protocol
  • Concurrent enrolment in another clinical trial where the subject is receiving an IMP or participation in another clinical trial with investigational product during the last 30 days before inclusion or 7 half-lives of previously used trial medication, whichever is longer.
  • Previous enrollment in a Tralokinumab clinical trial.
  • Active dermatologic conditions that may confound the diagnosis of AD or would interfere with assessment of treatment, such as scabies, cutaneous lymphoma, or psoriasis.
  • Known active allergic or irritant contact dermatitis that is likely to interfere with the assessment of severity of AD.
  • Subject with mild atopic dermatitis (EASI<12 and IGA<3) or is not a candidate or is not eligible for Tralokinumab treatment, because of a known or suspected allergy or reaction to any component of the IMP formulation or other possible contraindications like trypanophobia
Show all 42Show fewer
  • Having used immunosuppressive/immunomodulating therapy (Systemic immunosuppressive/immunomodulating drugs (e.g. methotrexate, cyclosporine, azathioprine, mycophenolate mofetil, Janus kinase inhibitors), systemic corticosteroid use (excludes topical, inhaled, or intranasal delivery, bleach baths) during any week within the 4 weeks or tanning beds or phototherapy (narrow band ultraviolet B [NBUVB], ultraviolet B [UVB], ultraviolet A1 [UVA1], psoralen + ultraviolet A [PUVA]), within 4 weeks before the baseline visit
  • Treatment of selected skin areas (non-lesional skin at volar forearm and extensor forearm, lesional skin) with topical corticosteroid or topical calcineurin inhibitor 1 week prior to baseline visit and throughout the study.
  • Treatment of skin areas of examination with emollients 24 hours prior to baseline visit and throughout the study.
  • Involvement in the planning and/or conduct of the study.
  • Dementia or significantly altered mental status that would prohibit the understanding or rendering of information, consent and compliance with the requirements of the protocol and patients who are legally institutionalized.
  • Pregnancy and breastfeeding are exclusion factors. The effects of Tralokinumab on the developing human fetus are unknown. Enrolled patients must agree to use adequate contraception prior to study entry, the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.
  • Medication that is known to interfere with any of the agents applied in the trial.
  • Receipt of live attenuated vaccines 30 days prior to the date of baseline and during the trial including the safety follow-up period.
  • Receipt of inactive/killed vaccinations (e.g. inactive influenza) is allowed, provided they are not administered within 5 days before/after any trial visit.
  • Receipt of any marketed biological therapy (i.e. immunoglobulin, anti-IgE) including dupilumab or investigational biologic agents:
  • Any cell-depleting agents including but not limited to rituximab: within 6 months prior to baseline or until lymphocyte count returns to normal whichever is longer.
  • Other biologics: within 3 months or 5 half-lives, whichever is longer prior to baseline.
  • Receipt of any investigational non-biologic agent within 5 half-lives prior to baseline.
  • Receipt of blood products within 4 weeks prior to screening.
  • Major surgery within 8 weeks prior to screening, or planned in-patient surgery or hospitalization during the trial period.
  • History of any active skin infection within 1 week prior to baseline.
  • History of a clinically significant infection within 4 weeks prior to baseline which, in the opinion of the investigator or sponsor, may compromise the safety of the subject in the trial, interfere with evaluation of the IMP, or reduce the subject's ability to participate in the trial. Clinically significant infections are defined as:
  • A systemic infection.
  • A serious skin infection requiring parenteral (intravenous or intramuscular) antibiotics, antiviral, or antifungal medication.
  • History of a helminthic parasitic infection within 6 months prior to the date informed consent is obtained that has not been treated with, or has failed to respond to, standard of care therapy.
  • History of anaphylaxis following any biological therapy.
  • History of immune complex disease.
  • History of cancer:
  • Subjects who have had basal cell carcinoma, localized squamous cell carcinoma of the skin or in situ carcinoma of the cervix are eligible provided that the subject is in remission and curative therapy was completed at least 12 months prior to the date informed consent was obtained.
  • Subjects who have had other malignancies are eligible provided that the subject is in remission and curative therapy was completed at least 5 years prior to the date informed consent was obtained.
  • History of tuberculosis requiring treatment within the 12 months prior to screening. Evaluation will be according to local guidelines as per local standard of care.
  • History of any known primary immunodeficiency disorder including a positive human immunodeficiency virus (HIV) test at screening, or the subject taking antiretroviral medications as determined by medical history and/or subject's verbal report.
  • History of chronic alcohol or drug abuse within 12 months prior to screening, or any condition associated with poor compliance as judged by the investigator.
  • Any disorder, including but not limited to, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, hematological, immunological, psychiatric, or major physical impairment that is not stable, in the opinion of the investigator, and could:
  • Affect the safety of the subject throughout the trial.
  • Influence the findings of the trial or their interpretations.
  • Impede the subject's ability to complete the entire duration of trial.
  • Any clinically significant abnormal findings in physical examination, vital signs, hematology or clinical chemistry during the screening period, which in the opinion of the investigator, may put the subject at risk because of his/her participation in the trial, or may influence the results of the trial, or the subject's ability to complete entire duration of the trial.
  • Positive hepatitis B surface antigen (HBsAg), hepatitis B surface antibody (HBsAb), hepatitis B core antibody (HBcAb) or hepatitis C virus antibody (anti-HCV) serology at screening.
  • Pregnant, breastfeeding, or lactating women.
  • Employees of the trial site or any other individuals directly involved

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • UKSH, Campus Kiel

    Kiel, Schleswig-Holstein, 24105

Other trials in Germany

About this study

Effects of tralokinumab treatment of atopic dermatitis on skin barrier function.

Read the detailed description

A phase II, monocenter , open, investigator initiated clinical trial investigating the effects of Tralokinumab treatment of atopic dermatitis on skin barrier physiology and function.

Being tested
Tralokinumab
Keywords
Skin Barrier, Atopic Dermatitis, Dermatology, Biologics
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

    2 x 300 mg Tralokinumab s.c. loading dose followed by 8 x 300 mg every 2 weeks (Q2W)

Study groups in NCT04556461
Study groupRoleWhat they receive
TralokinumabExperimentalTralokinumab 600mg loading dose s.c., followed by 300mg every other week.
Receives: Drug: Tralokinumab

What is being measured

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

  1. Skin barrier function

    Primary Endpoint is the change in transepidermal water loss (TEWL) at one non-lesional and one lesional marker skin area at week 16 (day 112) compared to baseline (day 0).

    Measured: 16 weeks

Secondary outcomes (3)

  1. Effect of tralokinumab treatment on skin irritability

    Change in skin irritability: Change in clinical score of sodium lauryl sulfate irritant reaction of non-lesional skin at week 16 compared to baseline (Erythema, Infiltration/Edema, Squamation, Oozing/Crusting will be evaluated on a 4-point scale with non-existent (0) to severe (3))

    Measured: 16 weeks

  2. Effect of Tralokinumab treatment on epidermal differentiation.

    Change of epidermal thickness of one lesional and one non-lesional marker skin area at week 16 compared to baseline (μm)

    Measured: 16 weeks

  3. Effect of tralokinumab treatment on disease activity.

    Mean percent change at week 16 from baseline in Eczema Area and Severity Index (EASI) (values from 0 to 72 possible, where an EASI >12 indicates a moderate to severe disesase)

    Measured: 16 weeks

Timeline

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

  1. First posted21 Sep 2020
  2. Study start28 Sep 2020
  3. Primary completion1 Jul 2022
  4. Study completion31 Mar 2023

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
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04556461
Sponsor's protocol ID
TRA-WEI-0015-I
Acronym
TraSki
Status last verified
Apr 2023
First submitted
16 Jul 2020
Last updated
21 Apr 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Eichenfield LF, Ahluwalia J, Waldman A, Borok J, Udkoff J, Boguniewicz M. Current guidelines for the evaluation and management of atopic dermatitis: A comparison of the Joint Task Force Practice Parameter and American Academy of Dermatology guidelines. J Allergy Clin Immunol. 2017 Apr;139(4S):S49-S57. doi: 10.1016/j.jaci.2017.01.009.

    PubMed 28390477

  • Weidinger S, Novak N. Atopic dermatitis. Lancet. 2016 Mar 12;387(10023):1109-1122. doi: 10.1016/S0140-6736(15)00149-X. Epub 2015 Sep 13.

    PubMed 26377142

  • Bieber T. Atopic dermatitis. Ann Dermatol. 2010 May;22(2):125-37. doi: 10.5021/ad.2010.22.2.125. Epub 2010 May 17.

    PubMed 20548901

  • Silverberg JI, Hanifin JM. Adult eczema prevalence and associations with asthma and other health and demographic factors: a US population-based study. J Allergy Clin Immunol. 2013 Nov;132(5):1132-8. doi: 10.1016/j.jaci.2013.08.031. Epub 2013 Oct 4.

    PubMed 24094544

  • Hanifin JM, Reed ML; Eczema Prevalence and Impact Working Group. A population-based survey of eczema prevalence in the United States. Dermatitis. 2007 Jun;18(2):82-91. doi: 10.2310/6620.2007.06034.

    PubMed 17498413

  • Kiebert G, Sorensen SV, Revicki D, Fagan SC, Doyle JJ, Cohen J, Fivenson D. Atopic dermatitis is associated with a decrement in health-related quality of life. Int J Dermatol. 2002 Mar;41(3):151-8. doi: 10.1046/j.1365-4362.2002.01436.x.

    PubMed 12010340

  • Tazawa T, Sugiura H, Sugiura Y, Uehara M. Relative importance of IL-4 and IL-13 in lesional skin of atopic dermatitis. Arch Dermatol Res. 2004 Apr;295(11):459-64. doi: 10.1007/s00403-004-0455-6. Epub 2004 Mar 10.

    PubMed 15014952

  • Omori-Miyake M, Yamashita M, Tsunemi Y, Kawashima M, Yagi J. In vitro assessment of IL-4- or IL-13-mediated changes in the structural components of keratinocytes in mice and humans. J Invest Dermatol. 2014 May;134(5):1342-1350. doi: 10.1038/jid.2013.503. Epub 2013 Nov 26.

    PubMed 24280725

  • Tsoi LC, Rodriguez E, Degenhardt F, Baurecht H, Wehkamp U, Volks N, Szymczak S, Swindell WR, Sarkar MK, Raja K, Shao S, Patrick M, Gao Y, Uppala R, Perez White BE, Getsios S, Harms PW, Maverakis E, Elder JT, Franke A, Gudjonsson JE, Weidinger S. Atopic Dermatitis Is an IL-13-Dominant Disease with Greater Molecular Heterogeneity Compared to Psoriasis. J Invest Dermatol. 2019 Jul;139(7):1480-1489. doi: 10.1016/j.jid.2018.12.018. Epub 2019 Jan 11.

    PubMed 30641038

  • Aleksza M, Lukacs A, Antal-Szalmas P, Hunyadi J, Szegedi A. Increased frequency of intracellular interleukin (IL)-13 and IL-10, but not IL-4, expressing CD4+ and CD8+ peripheral T cells of patients with atopic dermatitis. Br J Dermatol. 2002 Dec;147(6):1135-41. doi: 10.1046/j.1365-2133.2002.05013.x.

    PubMed 12452862

  • Purwar R, Werfel T, Wittmann M. IL-13-stimulated human keratinocytes preferentially attract CD4+CCR4+ T cells: possible role in atopic dermatitis. J Invest Dermatol. 2006 May;126(5):1043-51. doi: 10.1038/sj.jid.5700085.

    PubMed 16484990

  • Oh MH, Oh SY, Lu J, Lou H, Myers AC, Zhu Z, Zheng T. TRPA1-dependent pruritus in IL-13-induced chronic atopic dermatitis. J Immunol. 2013 Dec 1;191(11):5371-82. doi: 10.4049/jimmunol.1300300. Epub 2013 Oct 18.

    PubMed 24140646

  • Zheng T, Oh MH, Oh SY, Schroeder JT, Glick AB, Zhu Z. Transgenic expression of interleukin-13 in the skin induces a pruritic dermatitis and skin remodeling. J Invest Dermatol. 2009 Mar;129(3):742-51. doi: 10.1038/jid.2008.295. Epub 2008 Oct 2.

    PubMed 18830273

  • Blauvelt A, de Bruin-Weller M, Gooderham M, Cather JC, Weisman J, Pariser D, Simpson EL, Papp KA, Hong HC, Rubel D, Foley P, Prens E, Griffiths CEM, Etoh T, Pinto PH, Pujol RM, Szepietowski JC, Ettler K, Kemeny L, Zhu X, Akinlade B, Hultsch T, Mastey V, Gadkari A, Eckert L, Amin N, Graham NMH, Pirozzi G, Stahl N, Yancopoulos GD, Shumel B. Long-term management of moderate-to-severe atopic dermatitis with dupilumab and concomitant topical corticosteroids (LIBERTY AD CHRONOS): a 1-year, randomised, double-blinded, placebo-controlled, phase 3 trial. Lancet. 2017 Jun 10;389(10086):2287-2303. doi: 10.1016/S0140-6736(17)31191-1. Epub 2017 May 4.

    PubMed 28478972

  • Simpson EL, Bieber T, Guttman-Yassky E, Beck LA, Blauvelt A, Cork MJ, Silverberg JI, Deleuran M, Kataoka Y, Lacour JP, Kingo K, Worm M, Poulin Y, Wollenberg A, Soo Y, Graham NM, Pirozzi G, Akinlade B, Staudinger H, Mastey V, Eckert L, Gadkari A, Stahl N, Yancopoulos GD, Ardeleanu M; SOLO 1 and SOLO 2 Investigators. Two Phase 3 Trials of Dupilumab versus Placebo in Atopic Dermatitis. N Engl J Med. 2016 Dec 15;375(24):2335-2348. doi: 10.1056/NEJMoa1610020. Epub 2016 Sep 30.

    PubMed 27690741

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Tralokinumab in people with Atopic Dermatitis, run by Prof. Dr. Stephan Weidinger at 1 site in Germany.

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 14 inclusion and 42 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 21 Apr 2023. 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 Germany. 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 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Skin barrier function (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 NCT04556461, which also lists 30 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 21 Apr 2023.

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