Effects of Tralokinumab Treatment of Atopic Dermatitis on Skin Barrier Function

NCT04556461 | Completed Phase 2 DMC

• 1 other identifier: TRA-WEI-0015-I
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Atopic Dermatitis

Keywords

Skin Barrier; Atopic Dermatitis; Dermatology; Biologics

Outcome Measures

Primary Outcomes (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).

  16 weeks

Secondary Outcomes (3)

• Effect of tralokinumab treatment on skin irritability

  16 weeks

• Effect of Tralokinumab treatment on epidermal differentiation.

  16 weeks

• Effect of tralokinumab treatment on disease activity.

  16 weeks

Other Outcomes (3)

• Effect of tralokinumab treatment on the skin transcriptome.

  16 weeks

• Effect of tralokinumab treatment on the skin proteome.

  16 weeks

• Effect of tralokinumab treatment on the skin microbiome.

  16 weeks

Study Arms (1)

Tralokinumab

EXPERIMENTAL

Tralokinumab 600mg loading dose s.c., followed by 300mg every other week.

Drug: Tralokinumab

Interventions

Tralokinumab DRUG

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

Tralokinumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

• Subject is unable to provide written informed consent or comply with the protocol
• 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
• 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.
• 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.
• a. 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.

Sponsors & Collaborators

• Prof. Dr. Stephan Weidinger: lead

Study Sites (1)

UKSH, Campus Kiel

Kiel, Schleswig-Holstein, 24105, Germany

Location

Related Publications (30)

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  PMID: 39733934 DERIVED

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

tralokinumab

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Vice Head

Study Record Dates

• First Submitted: July 16, 2020
• First Posted: September 21, 2020
• Study Start: September 28, 2020
• Primary Completion: July 1, 2022
• Study Completion: March 31, 2023
• Last Updated: April 21, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)