NM26-2198 for Atopic Dermatitis/Eczema

No longer recruiting at 23 trial locations

Overseen By Peter Lichtlen, MD, PhD, BBA

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Yellow Jersey Therapeutics AG

Must be taking: Non-prescription emollient

Must not be taking: Sedating antihistamines, systemic corticosteroids

Disqualifiers: HIV, Hepatitis B, Hepatitis C, others

Compensation: Varies

Number of Visits: 5

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called NM26-2198 for individuals with moderate to severe atopic dermatitis, also known as eczema. The trial aims to assess the treatment's safety, how the body processes it, and its effects on the immune system. Individuals with eczema covering at least 10% of their body and who regularly use non-prescription skin moisturizers may be suitable candidates for this trial. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive it.

Will I have to stop taking my current medications?

The trial requires that participants do not use certain medications, including sedating antihistamines, systemic corticosteroids, and other immunosuppressive agents. If you are taking these, you may need to stop before joining the trial.

Is there any evidence suggesting that NM26-2198 is likely to be safe for humans?

Research shows that NM26-2198 has promising safety results in animal studies. Tests with monkeys, even at high doses of 125 mg/kg weekly, revealed no harmful effects. This suggests the treatment might be well-tolerated, though humans can react differently. Currently, NM26-2198 is in the early stages of human testing. This first phase focuses on understanding safety and is crucial for assessing how humans handle the treatment. While animal studies are encouraging, the ongoing trial will provide more specific safety information for humans. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for eczema?

Most treatments for atopic dermatitis, like topical steroids and immunosuppressants, work by reducing inflammation and suppressing the immune system. But NM26-2198 offers a new approach by being administered as a subcutaneous injection with varying doses, which may provide more tailored and potentially more effective treatment options. Researchers are excited about NM26-2198 because it could offer a more targeted way to manage eczema symptoms, with the possibility of improved efficacy and fewer side effects compared to conventional therapies. This innovative delivery method and dosing flexibility are what set NM26-2198 apart from current treatments.

What evidence suggests that NM26-2198 might be an effective treatment for atopic dermatitis?

Research shows that NM26-2198, which participants in this trial may receive, could be a promising treatment for atopic dermatitis, a type of eczema. It targets two important pathways in the body, IL-4/IL-13 and IL-31, linked to the inflammation and itching seen in eczema. NM26-2198 matches the effectiveness of current treatments like dupilumab, which also targets IL-4/IL-13. Studies have shown that addressing both pathways simultaneously is more effective than focusing on just one. This dual-action approach may offer better relief for people with eczema symptoms. ^{1 2 5 6 7}

Who Is on the Research Team?

Yellow Jersey Therapeutics AG Clinical trial

Principal Investigator

Yellow Jersey Therapeutics AG

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I have been diagnosed with chronic Alzheimer's disease.

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

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

Exclusion Criteria

I have a current infection needing specific treatments.

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

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Single Ascending Dose (SAD) Treatment

Participants receive a single subcutaneous dose of NM26-2198 or placebo

8 weeks

1 visit (in-person) on Day 1, follow-up visits through Day 57

Multiple Ascending Dose (MAD) Treatment

Participants receive multiple subcutaneous doses of NM26-2198 or placebo on Days 1, 8, 15, and 22

12 weeks

4 visits (in-person) on Days 1, 8, 15, and 22, follow-up visits through Day 85

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• NM26-2198
• Placebo

Trial Overview 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.

How Is the Trial Designed?

Group I: NM26-2198 Experimental Treatment 1 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 and 300mg for SC injection in patients with AD on Days 1, 8, 15, and 22 (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: Placebo Placebo Group 1 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)

Who Is Running the Clinical Trial?

Yellow Jersey Therapeutics AG

Lead Sponsor

Trials

1

Recruited

130+

Numab Therapeutics AG

Lead Sponsor

Trials

3

Recruited

360+

Kaken Pharmaceutical Co., Ltd.

Collaborator

Trials

1

Recruited

130+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10875227/

A Bispecific, Tetravalent Antibody Targeting Inflammatory and ... NM26-2198 concomitantly inhibited IL-4/IL-13 and IL-31 signaling with a potency comparable with that of the combination of an anti–IL-4Rα antibody (dupilumab) ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05859724

Study Details | NCT05859724 | Evaluation of NM26-2198 ... This is a randomized, double-blind, placebo-controlled, single- and multiple ascending dose study of subcutaneous (SC) administration of NM26-2198 in healthy ...

3. jnj.com jnj.com/media-center/press-releases/johnson-johnson-to-obtain-rights-to-a-clinical-stage-bispecific-antibody-to-address-distinct-patient-needs-in-atopic-dermatitis

The Company 1 enters agreement with Numab ... NM26, a Phase 2-ready investigational, first-in-class bispecific antibody targeting two clinically proven pathways in atopic dermatitis (AD).

4. numab.com numab.com/wp-content/uploads/230514-Numab-Therapeutics-Announces-First-Subject-Dosed-NM26.pdf

NM26-2198 is a first-in-class bi-specific antibody designed ... NM26-2198 is a bi-specific antibody which targets IL-4Rα (type I and type II receptors) and IL-31 for the treatment of atopic dermatitis (AD).

5. synapse.patsnap.com synapse.patsnap.com/article/advancements-in-atopic-dermatitis-treatment-a-focus-on-nm26-2198-a-dual-targeting-bispecific-antibody

A Focus on NM26-2198, a Dual-Targeting Bispecific Antibody It has been shown to be more effective than single-pathway inhibition, as demonstrated by its superior suppression of CCL2 release from ...

6. ctv.veeva.com ctv.veeva.com/study/a-clinical-trial-to-evaluate-the-safety-tolerability-pharmacokinetics-immunogenicity-pharmacodyn

Evaluation of NM26-2198 in Healthy Subjects and in Patients ... This is a randomized, double-blind, placebo-controlled, single- and multiple ascending dose study of subcutaneous (SC) administration of NM26-2198 in healthy ...

7. numab.com numab.com/wp-content/uploads/Numab_EADV-2022_NM26_Poster_Final-1.pdf

The development and characterization of NM26-2198, an ... NM26-2198 is designed to prevent IL-4 and IL-31-induced keratinocyte immunopathology, immune cell activation, barrier defects and pruritus (itch phenotype) in ...