Atopic DermatitisPhase 1NCT05859724
Evaluation of NM26-2198 in Healthy Subjects and in Patients With Moderate-to-severe Atopic Dermatitis (AD)
A Phase 1 study testing NM26-2198 in people with Atopic Dermatitis, run by Yellow Jersey Therapeutics AG at 15 sites in 4 countries.
Trial summary
This is a randomized, double-blind, placebo-controlled, single- and multiple ascending dose study of subcutaneous (SC) administration of NM26-2198 in healthy volunteers and adult patients with moderate to-severe AD to evaluate the safety, tolerability, pharmacokinetics (PK), and immunogenicity of single (SAD) and… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- NM26-2198
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 126 participants
- Where
- 15 sitesin 4 countries
- Study dates
- 10 May 2023to 17 Oct 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- SAD: Non-Asian ethnicity with grandparents and parents of non-Asian descent or Japanese descent having all four Japanese grandparents born in Japan.
- SAD and MAD in Healthy Volunteers: Male or female aged 18 to 55 years; MAD: Male or female ≥18 years of age.
- ALL COHORTS: Weight of 45 kg to 100 kg and BMI of 18.0 to 30.0 kg/m2.
- SAD and MAD in Healthy Volunteers: Non-childbearing, non-breastfeeding females or males willing to use double barrier contraception or abstention from sex and sperm donation during the study; MAD: Males willing to use double barrier contraception or abstention from sex and sperm donation during the study; non-childbearing females or females of childbearing potential using protocol-defined method contraception, and who is not pregnant, lactating, or breastfeeding.
- MAD: Diagnosis of chronic AD.
- MAD: EASI score ≥16.
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- MAD: vIGA-AD™ score of ≥3.
- MAD: Atopic lesions cover ≥10% of body surface area (BSA).
- MAD: PP-NRS score ≥4.
- MAD: Daily use of non-prescription emollient.
- Note: Other protocol-defined Inclusion criteria apply.
Who cannot join
- SAD and MAD in Healthy Volunteers: Any clinically-relevant medical history or lab abnormality, including positive test for SARS-CoV-2, Hepatitis B or C, or HIV; MAD: Clinically-significant, abnormal laboratory findings, or positive test for SARS-CoV-2, Hepatitis B or C, or HIV.
- ALL COHORTS: Clinically important ECG abnormalities or history/evidence thereof.
- SAD and MAD in Healthy Volunteers: Use of prescription or non-prescription medications (except occasional use of paracetamol).
- MAD: Diagnosis of protocol-specified skin diseases other than AD, or history of other significant skin condition that could interfere with study assessments.
- MAD: History or ongoing allergy/hypersensitivity or history, or history of hypersensitivity to biological drugs.
- MAD: Recent receipt of immunoglobulin or blood products.
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- MAD: Recent treatment with protocol-specified investigational treatments, or any prior treatment with dupilumab, tralokinumab, lebrikizumab, nemolizumab, or other protocol-specified drugs.
- MAD: AD with recent ocular involvement requiring chronic ocular corticosteroid treatment.
- MAD: Chronic pruritis due to conditions other than AD.
- MAD: Acute AD superinfection, recent superficial skin infection, or other chronic/acute infection requiring protocol-defined treatments.
- MAD: Recent use of sedating antihistimines, systemic corticosteroids, cytotoxic treatments, other immunosuppressive/immunomodulating agents, and other protocol-specified prohibited medications.
- MAD: Recent topical corticosteroid or prescription moisturizer use.
- Note: Other protocol-defined Exclusion criteria apply.
Trial locations and contacts
15 sites in 4 countries.
15 sites in 4 countries
United States6 sites
First OC Dermatology Research
Fountain Valley, California, 92708
California Clinical Trials Medical Group (CCTMG) managed by Parexel
Glendale, California, 91206
Sadick Research Group
New York, New York, 10075
Paddington Testing Co.
Philadelphia, Pennsylvania, 19103
TCR Medical Corporation
San Diego, California, 92123
D&H Tamarac Research Center
Tamarac, Florida, 33321
Poland4 sites
COPERNICUS Podmiot Leczniczy Sp. z o.o., Szpital Sw. Wojciecha
Gdansk, 80-462
Uniwersytecki Szpital Kliniczny im. F.Chopina w Rzeszowie
Rzeszów, 35-055
Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych
Warsaw, 02-507
Klinika Ambroziak Dermatologia
Warsaw, 02-953
Germany3 sites
Universitätsklinikum Carl Gustav Carus
Dresden, Saxony, 01307
UK-SH - Lübeck
Lübeck, Schleswig-Holstein, 23538
Universitätsmedizin Mainz
Mainz, Hesse, 55131
Canada2 sites
DermEffects
London, Ontario, N6H5L5
Centre de Recherche Saint-Louis
Québec, G1W4R4
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Single- and Multiple-ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, Pharmacodynamics and Exploratory Clinical Activity of NM26-2198 in Healthy Volunteers and in Adult Patients With Atopic Dermatitis
This is a randomized, double-blind, placebo-controlled, single- and multiple ascending dose study of subcutaneous (SC) administration of NM26-2198 in healthy volunteers and adult patients with moderate to-severe AD to evaluate the safety, tolerability, pharmacokinetics (PK), and immunogenicity of single (SAD) and multiple doses (MAD) of NM26-2198.
- Conditions
- Atopic Dermatitis
- Being tested
- NM26-2198, Placebo
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NM26-2198Biological
IL-4R/IL-31 bispecific antibody for subcutaneous administration
PlaceboOther
Placebo for NM26-2198
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | 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) Receives: Other: Placebo |
| NM26-2198 | Experimental | 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) Receives: Biological: NM26-2198 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants with Treatment Emergent Adverse Events (TEAEs) [SAD]
TEAEs defined as AEs and SAEs developing or worsening during treatment period (time from the first dose of study drug up to the end of study visit [Day 57 in SAD]), and includes findings from vital signs, electrocardiogram (ECG), clinical laboratory tests, physical examinations, and injection site evaluations.
Measured: First dose through end of study (Day 57)
Percentage of participants with Treatment Emergent Adverse Events (TEAEs) [MAD]
TEAEs defined as AEs and SAEs developing or worsening during treatment period (time from the first dose of study drug up to the end of study visit [Day 85 in MAD]), and includes findings from vital signs, electrocardiogram (ECG), clinical laboratory tests, physical examinations, and injection site evaluations.
Measured: First dose through end of study (Day 85)
Secondary outcomes (31)
Pharmacokinetics of NM26-2198: Peak Concentration (Cmax) [SAD]
Mean maximum concentration of NM26-2198 after single dose administration in healthy subjects.
Measured: Pre-dose on Day 1 through Day 57
Pharmacokinetics of NM26-2198: Peak Concentration (Cmax) [MAD]
Mean maximum concentration of NM26-2198 after multiple dose administrations in healthy volunteers and in patients with AD.
Measured: Pre-dose on Day 1 through Day 85
Pharmacokinetics of NM26-2198: Trough Concentration (Ctrough) [MAD]
Mean trough concentrations of NM26-2198 with multiple dose administrations in healthy volunteers and in patients with AD.
Measured: Pre-dose on Day 1 through Day 85
Pharmacokinetics of NM26-2198: Time of Peak Concentration (Tmax) [SAD]
Mean time of maximum concentration of NM26-2198 after single dose administration in healthy subjects.
Measured: Pre-dose on Day 1 through Day 57
Pharmacokinetics of NM26-2198: Time of Peak Concentration (Tmax) [MAD]
Mean time of maximum concentration of NM26-2198 after multiple dose administrations in healthy volunteers and in patients with AD.
Measured: Pre-dose on Day 1 through Day 85
Pharmacokinetics of NM26-2198: Last Area Under the Curve (AUClast) [SAD]
Mean area under the curve from the time of dosing to the last measurable concentration of NM26-2198 after single dose administration in healthy subjects.
Measured: Pre-dose on Day 1 through Day 57
Pharmacokinetics of NM26-2198: Last Area Under the Curve (AUClast) [MAD]
Mean area under the curve from the time of dosing to the last measurable concentration of NM26-2198 after multiple dose administrations in healthy volunteers and in patients with AD.
Measured: Pre-dose on Day 1 through Day 85
Pharmacokinetics of NM26-2198: Area Under the Curve During the Dosing Interval (AUCtau) [SAD]
Mean area under concentration-time curve over dosing interval of NM26-2198 after single dose administration in healthy subjects.
Measured: Pre-dose on Day 1 through Day 7
Pharmacokinetics of NM26-2198: Area Under the Curve During the Dosing Interval (AUCtau) [MAD]
Mean area under concentration-time curve over dosing interval of NM26-2198 after multiple dose administrations in healthy volunteers and in patients with AD.
Measured: Pre-dose on Day 1 through Day 29
Pharmacokinetics of NM26-2198: Estimated Total Exposure (AUCinf) [SAD]
Mean estimated total exposure to NM26-2198 after single dose administration in healthy subjects.
Measured: Pre-dose on Day 1 through Day 57
Pharmacokinetics of NM26-2198: Estimated Total Exposure (AUCinf) [MAD]
Mean estimated total exposure to NM26-2198 after multiple dose administrations in healthy volunteers and in patients with AD.
Measured: Pre-dose on Day 1 through Day 85
Pharmacokinetics of NM26-2198: Time-Averaged Concentration (AUC%extrap) [SAD]
Mean time-averaged concentration of NM26-2198 after single dose administration in healthy subjects.
Measured: Pre-dose on Day 1 through Day 57
Pharmacokinetics of NM26-2198: Time-Averaged Concentration (AUC%extrap) [MAD]
Mean time-averaged concentration of NM26-2198 after multiple dose administrations in healthy volunteers and in patients with AD.
Measured: Pre-dose on Day 1 through Day 85
Pharmacokinetics of NM26-2198: Time of last quantifiable concentration (tlast) [SAD]
Mean estimated time to last quantificable concentration of NM26-2198 after single dose administration in healthy subjects.
Measured: Pre-dose on Day 1 through Day 57
Pharmacokinetics of NM26-2198: Time of last quantifiable concentration (tlast) [MAD]
Mean estimated time to last quantificable concentration of NM26-2198 after multiple dose administration in healthy volunteers and in patients with AD.
Measured: Pre-dose on Day 1 through Day 85
Pharmacokinetics of NM26-2198: Terminal Elimination Rate (λz) [SAD]
Mean terminal elimination rate of NM26-2198 after single dose administrations in healthy subjects.
Measured: Pre-dose on Day 1 through Day 57
Pharmacokinetics of NM26-2198: Terminal Elimination Rate (λz) [MAD]
Mean terminal elimination rate of NM26-2198 after multiple dose administrations in healthy volunteers and in patients with AD.
Measured: Pre-dose on Day 1 through Day 85
Pharmacokinetics of NM26-2198: Terminal elimination half-life (t1/2) [SAD]
Mean terminal elimination half-life of NM26-2198 after single dose administration in healthy subjects.
Measured: Pre-dose on Day 1 through Day 57
Pharmacokinetics of NM26-2198: Terminal elimination half-life (t1/2) [MAD]
Mean terminal elimination half-life of NM26-2198 after multiple dose administrations in healthy volunteers and in patients with AD.
Measured: Pre-dose on Day 1 through Day 85
Pharmacokinetics of NM26-2198: Total body clearance (CL/F) [SAD]
Mean total body clearance of NM26-2198 after single dose administration in healthy subjects.
Measured: Day 1
Pharmacokinetics of NM26-2198: Total body clearance (CL/F) [MAD]
Mean total body clearance of NM26-2198 after multiple dose administrations in healthy volunteers and in patients with AD.
Measured: Day 1 and Day 22
Pharmacokinetics of NM26-2198: Apparent volume of distribution (Vz/F) [SAD]
Mean apparent volume of distribution of NM26-2198 after single dose administrations in healthy subjects.
Measured: Day 1
Pharmacokinetics of NM26-2198: Apparent volume of distribution (Vz/F) [MAD]
Mean apparent volume of distribution of NM26-2198 after multiple dose administrations in healthy volunteers and in patients with AD.
Measured: Day 1 and Day 22
Pharmacokinetics of NM26-2198: Accumulation ratio of last dose Cmax (Racc,cmax) [MAD]
Mean accumulation ratio of last dose Cmax of NM26-2198 after multiple dose administrations in healthy volunteers and in patients with AD.
Measured: Day 1 through Day 22
Pharmacokinetics of NM26-2198: Accumulation ratio of last dose AUCtau (Racc,AUCtau) [MAD]
Mean accumulation ratio of last dose AUCtau of NM26-2198 after multiple dose administrations in healthy volunteers and in patients with AD.
Measured: Day 1 through Day 22
Percentage of subjects developing treatment-emergent anti-drug antibodies (ADAs) [SAD]
Measured: Pre-dose on Day 1 through Day 57
Percentage of subjects developing treatment-emergent anti-drug antibodies (ADAs) [MAD]
Measured: Pre-dose on Day 1 through Day 85
Percentage of subjects developing treatment-enhanced anti-drug antibodies (ADAs) [SAD]
Measured: Pre-dose on Day 1 through Day 57
Percentage of subjects developing treatment-enhanced anti-drug antibodies (ADAs) [MAD]
Measured: Pre-dose on Day 1 through Day 85
Mean ADA titers [SAD]
Measured: Pre-dose on Day 1 through Day 57
Mean ADA titers [MAD]
Measured: Pre-dose on Day 1 through Day 85
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2023
- Study start10 May 2023
- Primary completion1 Oct 2024
- Study completion17 Oct 2024
Why it stopped: Asset acquisition by Johnson \& Johnson. Minimum study objectives necessary to inform safety, tolerability, and dose selection for Phase 2 dose-ranging evaluation of NM26-2198 were achieved, with full completion of all healthy volunteer cohorts.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yellow Jersey Therapeutics AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yellow Jersey Therapeutics AG Clinical trial, Study director, Yellow Jersey Therapeutics AG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05859724
- Sponsor's protocol ID
- NB-NM026-2198-101
- Other IDs
- 2023-503577-38, 2023
- Status last verified
- Jul 2026
- First submitted
- 5 May 2023
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Single- and Multiple-ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, Pharmacodynamics and Exploratory Clinical Activity of NM26-2198 in Healthy Volunteers and in Adult Patients With Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT05859724
- Acronym / sponsor ID
- NB-NM026-2198-101
- Conditions
- Atopic Dermatitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Asset acquisition by Johnson \& Johnson. Minimum study objectives necessary to inform safety, tolerability, and dose selection for Phase 2 dose-ranging evaluation of NM26-2198 were achieved, with full completion of all healthy volunteer cohorts.
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Yellow Jersey Therapeutics AGIndustry (pharma, biotech, devices)
- Study start
- 10 May 2023 (actual)
- Primary completion
- 1 Oct 2024 (actual)
- Study completion
- 17 Oct 2024 (actual)
- First posted
- 16 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized, double-blind, placebo-controlled, single- and multiple ascending dose study of subcutaneous (SC) administration of NM26-2198 in healthy volunteers and adult patients with moderate to-severe AD to evaluate the safety, tolerability, pharmacokinetics (PK), and immunogenicity of single (SAD) and multiple doses (MAD) of NM26-2198.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: PlaceboPlacebo (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) |
| NM26-2198 | Experimental | Biological: NM26-2198NM26-2198 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- SAD: Non-Asian ethnicity with grandparents and parents of non-Asian descent or Japanese descent having all four Japanese grandparents born in Japan.
- SAD and MAD in Healthy Volunteers: Male or female aged 18 to 55 years; MAD: Male or female ≥18 years of age.
- ALL COHORTS: Weight of 45 kg to 100 kg and BMI of 18.0 to 30.0 kg/m2.
- SAD and MAD in Healthy Volunteers: Non-childbearing, non-breastfeeding females or males willing to use double barrier contraception or abstention from sex and sperm donation during the study; MAD: Males willing to use double barrier contraception or abstention from sex and sperm donation during the study; non-childbearing females or females of childbearing potential using protocol-defined method contraception, and who is not pregnant, lactating, or breastfeeding.
- MAD: Diagnosis of chronic AD.
Key exclusion criteria (13 listed)
- SAD and MAD in Healthy Volunteers: Any clinically-relevant medical history or lab abnormality, including positive test for SARS-CoV-2, Hepatitis B or C, or HIV; MAD: Clinically-significant, abnormal laboratory findings, or positive test for SARS-CoV-2, Hepatitis B or C, or HIV.
- ALL COHORTS: Clinically important ECG abnormalities or history/evidence thereof.
- SAD and MAD in Healthy Volunteers: Use of prescription or non-prescription medications (except occasional use of paracetamol).
- MAD: Diagnosis of protocol-specified skin diseases other than AD, or history of other significant skin condition that could interfere with study assessments.
- MAD: History or ongoing allergy/hypersensitivity or history, or history of hypersensitivity to biological drugs.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NM26-2198IL-4R/IL-31 bispecific antibody for subcutaneous administration | Biological | NM26-2198 |
| PlaceboPlacebo for NM26-2198 | Other | Placebo |
Primary outcome
Percentage of participants with Treatment Emergent Adverse Events (TEAEs) [SAD]
Time frame: First dose through end of study (Day 57)
TEAEs defined as AEs and SAEs developing or worsening during treatment period (time from the first dose of study drug up to the end of study visit [Day 57 in SAD]), and includes findings from vital signs, electrocardiogram (ECG), clinical laboratory tests, physical examinations, and injection site evaluations.
Percentage of participants with Treatment Emergent Adverse Events (TEAEs) [MAD]
Time frame: First dose through end of study (Day 85)
TEAEs defined as AEs and SAEs developing or worsening during treatment period (time from the first dose of study drug up to the end of study visit [Day 85 in MAD]), and includes findings from vital signs, electrocardiogram (ECG), clinical laboratory tests, physical examinations, and injection site evaluations.
31 secondary outcomes
Pharmacokinetics of NM26-2198: Peak Concentration (Cmax) [SAD]
Time frame: Pre-dose on Day 1 through Day 57
Pharmacokinetics of NM26-2198: Peak Concentration (Cmax) [MAD]
Time frame: Pre-dose on Day 1 through Day 85
Pharmacokinetics of NM26-2198: Trough Concentration (Ctrough) [MAD]
Time frame: Pre-dose on Day 1 through Day 85
Pharmacokinetics of NM26-2198: Time of Peak Concentration (Tmax) [SAD]
Time frame: Pre-dose on Day 1 through Day 57
Pharmacokinetics of NM26-2198: Time of Peak Concentration (Tmax) [MAD]
Time frame: Pre-dose on Day 1 through Day 85
Pharmacokinetics of NM26-2198: Last Area Under the Curve (AUClast) [SAD]
Time frame: Pre-dose on Day 1 through Day 57
Pharmacokinetics of NM26-2198: Last Area Under the Curve (AUClast) [MAD]
Time frame: Pre-dose on Day 1 through Day 85
Pharmacokinetics of NM26-2198: Area Under the Curve During the Dosing Interval (AUCtau) [SAD]
Time frame: Pre-dose on Day 1 through Day 7
Pharmacokinetics of NM26-2198: Area Under the Curve During the Dosing Interval (AUCtau) [MAD]
Time frame: Pre-dose on Day 1 through Day 29
Pharmacokinetics of NM26-2198: Estimated Total Exposure (AUCinf) [SAD]
Time frame: Pre-dose on Day 1 through Day 57
Pharmacokinetics of NM26-2198: Estimated Total Exposure (AUCinf) [MAD]
Time frame: Pre-dose on Day 1 through Day 85
Pharmacokinetics of NM26-2198: Time-Averaged Concentration (AUC%extrap) [SAD]
Time frame: Pre-dose on Day 1 through Day 57
Pharmacokinetics of NM26-2198: Time-Averaged Concentration (AUC%extrap) [MAD]
Time frame: Pre-dose on Day 1 through Day 85
Pharmacokinetics of NM26-2198: Time of last quantifiable concentration (tlast) [SAD]
Time frame: Pre-dose on Day 1 through Day 57
Pharmacokinetics of NM26-2198: Time of last quantifiable concentration (tlast) [MAD]
Time frame: Pre-dose on Day 1 through Day 85
Pharmacokinetics of NM26-2198: Terminal Elimination Rate (λz) [SAD]
Time frame: Pre-dose on Day 1 through Day 57
Pharmacokinetics of NM26-2198: Terminal Elimination Rate (λz) [MAD]
Time frame: Pre-dose on Day 1 through Day 85
Pharmacokinetics of NM26-2198: Terminal elimination half-life (t1/2) [SAD]
Time frame: Pre-dose on Day 1 through Day 57
Pharmacokinetics of NM26-2198: Terminal elimination half-life (t1/2) [MAD]
Time frame: Pre-dose on Day 1 through Day 85
Pharmacokinetics of NM26-2198: Total body clearance (CL/F) [SAD]
Time frame: Day 1
Pharmacokinetics of NM26-2198: Total body clearance (CL/F) [MAD]
Time frame: Day 1 and Day 22
Pharmacokinetics of NM26-2198: Apparent volume of distribution (Vz/F) [SAD]
Time frame: Day 1
Pharmacokinetics of NM26-2198: Apparent volume of distribution (Vz/F) [MAD]
Time frame: Day 1 and Day 22
Pharmacokinetics of NM26-2198: Accumulation ratio of last dose Cmax (Racc,cmax) [MAD]
Time frame: Day 1 through Day 22
Pharmacokinetics of NM26-2198: Accumulation ratio of last dose AUCtau (Racc,AUCtau) [MAD]
Time frame: Day 1 through Day 22
Percentage of subjects developing treatment-emergent anti-drug antibodies (ADAs) [SAD]
Time frame: Pre-dose on Day 1 through Day 57
Percentage of subjects developing treatment-emergent anti-drug antibodies (ADAs) [MAD]
Time frame: Pre-dose on Day 1 through Day 85
Percentage of subjects developing treatment-enhanced anti-drug antibodies (ADAs) [SAD]
Time frame: Pre-dose on Day 1 through Day 57
Percentage of subjects developing treatment-enhanced anti-drug antibodies (ADAs) [MAD]
Time frame: Pre-dose on Day 1 through Day 85
Mean ADA titers [SAD]
Time frame: Pre-dose on Day 1 through Day 57
Mean ADA titers [MAD]
Time frame: Pre-dose on Day 1 through Day 85
Results and safety
The study was stopped early (reason given: Asset acquisition by Johnson \& Johnson. Minimum study objectives necessary to inform safety, tolerability, and dose selection for Phase 2 dose-ranging evaluation of NM26-2198 were achieved, with full completion of all healthy volunteer cohorts.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yellow Jersey Therapeutics AG Clinical trial study director
Yellow Jersey Therapeutics AG
15 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing NM26-2198 in people with Atopic Dermatitis, run by Yellow Jersey Therapeutics AG at 15 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States, Poland, Germany, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Asset acquisition by Johnson \& Johnson. Minimum study objectives necessary to inform safety, tolerability, and dose selection for Phase 2 dose-ranging evaluation of NM26-2198 were achieved, with full completion of all healthy volunteer cohorts.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of participants with Treatment Emergent Adverse Events (TEAEs) [SAD] (time frame: First dose through end of study (Day 57)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026.