CALM-AD: A study evaluating the efficacy and safety of LUM-2841 topical cream in adults with moderate to severe atopic dermatitis
CALM-AD is a 16-week randomised study investigating LUM-2841, an investigational topical cream targeting skin inflammation in atopic dermatitis (eczema). Participants will be randomly assigned to apply either LUM-2841 or a placebo cream twice daily to affected areas. The study aims to assess improvement in eczema severity, itch and quality of life, along with the safety and tolerability of the treatment.
Study details:
CALM-AD is a 16-week study investigating LUM-2841, an investigational topical cream that targets skin inflammation in atopic dermatitis (eczema). Participants will be randomly assigned to apply either LUM-2841 or a placebo cream twice daily to affected areas. Approximately 40 participants will be enrolled at this site.
Participation involves 7 clinic visits and 2 phone check-ins over roughly 20 weeks including screening and follow-up. The study schedule includes a screening visit (Week -4 to -1), a baseline/randomisation visit (Week 0), phone check at Week 1, clinic visits at Weeks 2, 4, 8, 12, and 16 (end of treatment), and a safety follow-up phone check at Week 20. Participants will be compensated for time and travel.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
- Male or female aged 18 to 65 years at screening
- Diagnosis of atopic dermatitis for at least 12 months (Hanifin and Rajka criteria)
- Moderate to severe disease at screening defined as EASI score of 16 or higher, IGA score of 3 or 4 and affected body surface area of 10 percent or more
- Documented history of inadequate response to topical corticosteroids within the past 6 months
- Willing to stop current topical eczema treatments during the washout period
- Willing and able to apply study cream twice daily and attend all visits
- Women of childbearing potential must agree to use highly effective contraception during the study
- Able to provide written informed consent in English
Exclusion criteria
- Other active skin conditions that would interfere with study assessments (for example psoriasis, seborrhoeic dermatitis, cutaneous lupus)
- Active skin infection requiring treatment within 1 week of baseline
- Use of biologic therapy (for example dupilumab) within 12 weeks or 5 half lives of baseline, whichever is longer
- Use of systemic immunosuppressants (for example oral corticosteroids, ciclosporin, methotrexate) within 4 weeks of baseline
- Use of phototherapy within 4 weeks of baseline
- Pregnant or breastfeeding, or planning pregnancy during the study
- History of malignancy within 5 years (excluding treated non melanoma skin cancer)
- Significant unstable medical condition at the discretion of the investigator
- Participation in another interventional clinical trial within 30 days of screening
- Known allergy to any component of the study cream
Eligibility
Age eligible for study : 18 Years to 65 Years
Healthy volunteers accepted : No
Gender eligible for study: ALL
Things to know
Study dates
Study start: 2026-08-03
Primary completion:
Study completion finish:
Study type
Drug
Phase
Study ID
CUSTOM-38A0F283CE4D
Intervention or treatment
Drug: LUM-2841 topical cream
Drug: Placebo cream
Conditions
- Atopic Dermatitis
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Research sites nearby
Closest Location:
JM Clinical
Select from list below to view details:
JM Clinical
Brisbane, Queensland, Australia
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Who is running the clinical trial?
Lumeris Therapeutics Pty Ltd
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
| Participant Group/Arm | Intervention/Treatment |
|---|---|
Experimental: LUM-2841 topical cream
| LUM-2841 topical cream |
Placebo Comparator: Placebo
| Placebo cream |
What is the study measuring?
Primary Outcome
Secondary Outcome
References
Clinical Trials Gov: CALM-AD: A study evaluating the efficacy and safety of LUM-2841 topical cream in adults with moderate to severe atopic dermatitisOther trials to consider
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