What side effects are associated with this type of intervention?

Common treatments for atopic dermatitis include topical corticosteroids, topical immunomodulators, and biologic agents. Topical corticosteroids can cause skin thinning, especially with prolonged use. Topical immunomodulators may lead to local skin irritation and a potential increased risk of skin infections. Biologic agents, such as dupilumab, which target specific immune pathways, are generally well-tolerated but can cause side effects like conjunctivitis, injection site reactions, and, less commonly, eosinophilia. Overall, while these treatments are effective, they come with a range of potential side effects that should be monitored by a healthcare provider.

What prior FDA approvals exist?

The FDA has approved several biologic agents for the treatment of atopic dermatitis, focusing on targeting specific immune pathways. Dupilumab, an IL-4 receptor alpha antagonist, was one of the first biologics approved for moderate-to-severe atopic dermatitis in adults and later for children. It works by inhibiting the signaling of IL-4 and IL-13, key cytokines involved in the inflammatory response. Other treatments under investigation or in use include JAK inhibitors like baricitinib and anti-IL-31 antibodies such as nemolizumab, which target different aspects of the immune response involved in atopic dermatitis.

What other types of research exist?

Promising novel alternatives for atopic dermatitis treatment in 2024 include: 1) Dupilumab, an IL-4 receptor alpha antagonist, which has shown significant efficacy in moderate-to-severe AD. 2) Tralokinumab, an IL-13 monoclonal antibody, which targets a key cytokine involved in AD pathogenesis. 3) Upadacitinib, a JAK1 inhibitor, which has demonstrated effectiveness in reducing AD symptoms. 4) Abrocitinib, another JAK1 inhibitor, offering a targeted approach to managing AD. These agents have shown promising results in clinical trials and provide new options for patients with moderate-to-severe AD.

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NM26-2198 for Atopic Dermatitis/Eczema

Phase 1

Recruiting

Research Sponsored by Numab Therapeutics AG

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of chronic AD

Atopic lesions cover ≥10% of body surface area (BSA)

Must not have

Recent use of sedating antihistimines, systemic corticosteroids, cytotoxic treatments, other immunosuppressive/immunomodulating agents, and other protocol-specified prohibited medications

Any clinically-relevant medical history or lab abnormality, including positive test for SARS-CoV-2, Hepatitis B or C, or HIV

Timeline

Screening 3 weeks

Treatment Varies

Follow Up pre-dose on day 1 through day 85

Summary

This trial tests a new injectable drug called NM26-2198 in healthy people and those with moderate to severe atopic dermatitis. The goal is to check its safety, how the body processes it, and if it triggers any immune responses.

Who is the study for?

Adults aged 18-55 with moderate-to-severe atopic dermatitis (AD) covering ≥10% of their body, who are not pregnant or breastfeeding and agree to use contraception. Participants must have specific scores on AD severity scales and be free from certain medications and conditions that could affect the trial results.

What is being tested?

The trial is testing NM26-2198, a new medication for AD given by injection under the skin. It's compared against a placebo in healthy people and those with AD to see how safe it is, how the body processes it, and if it causes any immune reactions.

What are the potential side effects?

Potential side effects include reactions at the injection site, general discomfort or changes in skin condition due to treatment. Since this is an investigational study, there may be unknown risks or side effects associated with NM26-2198.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with chronic Alzheimer's disease.

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My skin condition affects more than 10% of my body.

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I am a male willing to use double barrier contraception or abstain from sex and sperm donation during the study.

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My pain level is 4 or higher on a scale of 0-10.

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I use over-the-counter skin moisturizer daily.

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I am between 18 and 55 years old.

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My weight is between 45 kg and 100 kg, and my BMI is between 18.0 and 30.0.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I haven't taken sedatives, steroids, chemotherapy drugs, or strong immune system medications recently.

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I do not have a significant medical history or current infections like COVID-19, Hepatitis B/C, or HIV.

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I only use medication occasionally, except for paracetamol.

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I have a skin condition that is not AD and could affect the study.

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I have recently received immunoglobulin or blood products.

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I have AD and need ongoing eye steroid treatment due to recent eye problems.

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I have not taken dupilumab, tralokinumab, lebrikizumab, nemolizumab, or similar drugs recently.

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I have long-term itching not caused by atopic dermatitis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ pre-dose on day 1 through day 85

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~pre-dose on day 1 through day 85

This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-dose on day 1 through day 85 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Percentage of participants with Treatment Emergent Adverse Events (TEAEs) [MAD]

Percentage of participants with Treatment Emergent Adverse Events (TEAEs) [SAD]

Secondary study objectives

Pharmacokinetics of NM26-2198: Accumulation ratio of last dose AUCtau (Racc,AUCtau) [MAD]

Pharmacokinetics of NM26-2198: Accumulation ratio of last dose Cmax (Racc,cmax) [MAD]

Pharmacokinetics of NM26-2198: Apparent volume of distribution (Vz/F) [MAD]

+22 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: NM26-2198Experimental Treatment1 Intervention

NM26-2198 10mg, 50mg, 150mg, 300mg, 400mg, 600mg, and 900mg for SC injection in HVs on Day 1 (SAD Part A); NM26-2198 150mg, 300mg, and 600mg for SC injection in patients with AD (MAD Part B); NM26-2198 150mg and 300mg for SC injection in HVs on Days 1, 8, 15, and 22 (MAD Part C)

Group II: PlaceboPlacebo Group1 Intervention

Placebo (for NM26-2198) for subcutaneous (SC) injection in healthy volunteers (HVs) on Day 1 (SAD Cohorts) and on Days 1, 8, 15, and 22 (MAD Cohorts)

0 / 15Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Atopic Dermatitis (AD) often involve biologic agents that target specific immune pathways to reduce inflammation and pruritus. For example, dupilumab blocks the IL-4 and IL-13 pathways, which are key drivers of the inflammatory response in AD. Tralokinumab targets IL-13, and nemolizumab targets the IL-31 receptor, both of which help to control chronic skin inflammation and itching. These treatments are significant for AD patients as they offer targeted therapy that can more effectively manage symptoms and improve quality of life compared to traditional treatments.