Blocking IL-13 to see how it changes itch and skin pain sensitivity

The Role of the Interleukin-13 Pathways on Pain and Itch Sensitivity in Patients With Atopic Dermatitis and Healthy Volunteers

This trial will test whether lebrikizumab, a drug that blocks IL-13, changes itch and skin pain sensitivity in healthy adults and people with atopic dermatitis.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years to 60 Years
• Sex: All
• Sponsor: Aalborg University (Academic / other)
• Drugs / interventions: Lebrikizumab
• Locations: 3 sites (Gistrup, Aalborg and 2 other locations)
• Trial ID: NCT06503510 on ClinicalTrials.gov

What this trial studies

The trial gives the IL-13 blocking antibody lebrikizumab and uses standard itch/pain provocation agents (histamine, cowhage, BAM8-22) to measure sensory responses. Both healthy adults and people with atopic dermatitis are included so researchers can compare responses across groups. Outcomes include subjective itch and pain ratings and objective sensory testing to map IL-13's role in neuronal sensitivity. This is the first human use of lebrikizumab specifically as an experimental tool to modulate IL-13 for mechanistic study of itch and pain.

Who should consider this trial

Good fit: Adults aged 18–60 who can attend in-person visits and are either healthy or have atopic dermatitis and meet the study's exclusion criteria may be eligible.

Not a fit: People who are pregnant or breastfeeding, use interfering medications, have active skin lesions or tattoos in the test area, have substance use or certain neurological, dermatological, immunological, cardiac, or psychiatric conditions, or cannot attend in-person visits are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, this work could clarify how IL-13 drives itch and pain and help guide better treatments that reduce these symptoms in people with atopic dermatitis.

How similar studies have performed: Drugs that block IL-13, including lebrikizumab, have reduced inflammation and itch in prior atopic dermatitis trials, but using such antibodies as experimental tools to probe acute itch and pain sensitivity in humans is novel.

Eligibility criteria

Inclusion Criteria:

* Healthy men and women
* 18-60 years

Exclusion Criteria:

* Pregnancy or lactation
* Drug addiction defined as any use of cannabis, opioids, or other drugs
* Previous or current history of neurological, dermatological (e.g., AD, psoriasis, etc.), immunological, musculoskeletal, cardiac disorder, or psychiatric diagnoses that may affect the results (e.g., neuropathy, muscular pain in the upper extremities, anxiety, depression, schizophrenia, etc.)
* Moles, wounds, scars, or tattoos in the area to be treated or tested
* Current use of medications that may affect the trial such as antihistamines and pain killers (use of antihistamines should be discontinued 72 hours before the experiment and all topical agents and emollients should be discontinued 24 hours before the experiment).
* Use of systemic and topical corticosteroids
* Consumption of alcohol or painkillers 24 hours before the study days and between these
* Acute or chronic pain
* Participation in other trials within one week of study entry (four weeks in the case of pharmaceutical trials)
* Lack of ability to cooperate

Where this trial is running

Gistrup, Aalborg and 2 other locations

• Aalborg University — Gistrup, Aalborg, Denmark (Recruiting)
• Cnap — Gistrup, Aalborg, Denmark (Active_not_recruiting)
• Aalborg University — Aalborg, Denmark, Denmark (Not_yet_recruiting)

Study contacts

• Study coordinator: Silvia Lo Vecchio

Conditions Itch