126 Participants Needed

NM26-2198 for Atopic Dermatitis/Eczema

Recruiting at 21 trial locations
PL
Overseen ByPeter Lichtlen, MD, PhD, BBA
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Yellow Jersey Therapeutics AG
Must be taking: Non-prescription emollient

Trial Summary

What is the purpose of this trial?

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.

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.

Research Team

YJ

Yellow Jersey Therapeutics AG Clinical trial

Principal Investigator

Yellow Jersey Therapeutics AG

Eligibility Criteria

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.
See 11 more

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.
See 11 more

Timeline

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

Treatment Details

Interventions

  • NM26-2198
  • Placebo
Trial OverviewThe 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.
Participant Groups
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 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: 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)

Find a Clinic Near You

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+