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Eczema drug may weaken vaccine protection, study finds

NCT ID NCT05899816

Knowledge-focused Sponsor: Amgen Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 24, 2026 · Updated 2 times

Summary

This study looked at whether rocatinlimab, a drug for moderate-to-severe eczema, changes how well vaccines work. About 221 adults with eczema received either the drug or a placebo, then got tetanus and meningococcal vaccines. The goal was to see if the drug lowers the body's ability to build protection from these vaccines.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

221 people

The number who actually took part.

Started

Jun 2023

Finished

Nov 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 54 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Age ≥ 18 years to 54 years with a diagnosis of AD according to the American Academy of Dermatology (AAD) Consensus Criteria (2014) present for at least 12 months * History of inadequate response to topical corticosteroids (TCS) of medium, high, or higher potency (with or without topical calcineurin inhibitors) * Subjects with previous systemic treatment for AD are also considered as inadequate responders to topical treatments and are potentially eligible to be included in the study after appropriate washout. * Validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD) score ≥ 3 Exclusion Criteria: * Treatment with a biologic product within 12 weeks or 5 half-lives, whichever is longer, prior to Day 1 * Treatment with any of the following medications or therapies within 4 weeks or 5 half-lives, whichever is longer, prior to Day 1: * Systemic corticosteroids * Systemic immunosuppressants * Phototherapy * Janus kinase inhibitors * Treatment with any of the following medications or therapies within 1 week, prior to Day 1: * TCS of any potency * Topical calcineurin inhibitors (TCI) * Topical Phosphodiesterase-4 inhibitors (PDE4) * Other topical immunosuppressive agents * Combination topical agents containing a corticosteroid or calcineurin inhibiting component, PDE4 inhibitors, or other topical immunosuppressive agents * Treatment with live virus including live attenuated vaccination 12 weeks prior to day 1 pre-randomization. * Treatment with any meningococcal vaccine within 1 year prior to screening, or treatment with any tetanus-, diphtheria-, or pertussis containing vaccine within 5 years prior to screening

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Conditions

The condition(s) this trial relates to.

atopic eczema

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Atopic dermatitis Moderate-to-severe atopic dermatitis

Contacts and locations

Locations

  • 310 Clinical Research

    Inglewood, California, 90301, United States

  • ActivMed Practices and Research, LLC

    Methuen, Massachusetts, 01844, United States

  • Affiliated Dermatology

    Scottsdale, Arizona, 85255, United States

  • AllerVie Clinical Research- Destin

    Destin, Florida, 32541, United States

  • AllerVie Clinical Research- Ocala

    Ocala, Florida, 34471, United States

  • Alliance for Multispecialty Research

    Coral Gables, Florida, 33134, United States

  • Anchor Medical Research

    Miami, Florida, 33176, United States

  • Apex Clinical Research Center LLC

    Mayfield Heights, Ohio, 44124, United States

  • Center for Dermatology and Plastic Surgery

    Scottsdale, Arizona, 85260, United States

  • Centre de Recherche Saint-Louis

    Québec, Quebec, G1W 4R4, Canada

  • Chemidox Clinical Trials Incorporated

    Lancaster, California, 93534, United States

  • Clinique de Dermatologie Rosemont

    Montreal, Quebec, H1Y 3L1, Canada

  • Cope Family Medicine

    Bountiful, Utah, 84010, United States

  • Cumberland Skin Center

    Hermitage, Tennessee, 37076, United States

  • Cura Clinical Research

    Sherman Oaks, California, 91403, United States

  • D and H Doral Research Centers

    Doral, Florida, 33122, United States

  • D and H National Research Centers

    Miami, Florida, 33155, United States

  • D and H Tamarac Research Centers

    Tamarac, Florida, 33321, United States

  • DermAtelier Clinical Research Incorporated

    Toronto, Ontario, M5M 3Z8, Canada

  • Dermatologic Surgery Specialists

    Macon, Georgia, 31217, United States

  • Dermatologist of Central States Clinical Research - Springfield

    Springfield, Ohio, 45505, United States

  • Dermatology Research Center of Oklahoma, PLLC

    Tulsa, Oklahoma, 74132, United States

  • Dermatology and Skin Cancer Center Leawood

    Leawood, Kansas, 66211, United States

  • Direct Helpers Research Center

    Hialeah, Florida, 33012, United States

  • Divine Dermatology and Aesthetics

    Atlanta, Georgia, 30315, United States

  • Doc1 Healthcare Systems

    Chino, California, 91710, United States

  • Epic Medical Research - Oklahoma

    Chickasha, Oklahoma, 73018, United States

  • Evidence Based Medical Educator Inc

    Toronto, Ontario, M5G 1E2, Canada

  • Excel Clinical Research

    Las Vegas, Nevada, 89109, United States

  • FACET Dermatology

    Toronto, Ontario, M4E 1R7, Canada

  • First Georgia Physicians Group

    Fayetteville, Georgia, 30214, United States

  • Forest Hills Dermatology Group

    Kew Gardens, New York, 11415, United States

  • Gold Coast Health Research Center

    Miami, Florida, 33155, United States

  • Guelph Dermatology Research

    Guelph, Ontario, N1L 0B7, Canada

  • Hamilton Research, LLC

    Alpharetta, Georgia, 30022, United States

  • Havana Research Institute Inc

    Pasadena, California, 91105, United States

  • Hickory Dermatology Research Center

    Hickory, North Carolina, 28602, United States

  • Hope Clinical Research LLC

    Canoga Park, California, 91303, United States

  • Indiana University School of Medicine

    Indianapolis, Indiana, 46202, United States

  • Integrative Skin Science and Research

    Sacramento, California, 95815, United States

  • Interior Dermatology Centre

    Kelowna, British Columbia, V1W 4V5, Canada

  • Karma Clinical Trials

    St. John's, Newfoundland and Labrador, A1A 4Y3, Canada

  • Kern Research Inc

    Bakersfield, California, 93301, United States

  • Kingsway Clinical Research

    Etobicoke, Ontario, M8X 1Y9, Canada

  • Las Vegas Clinical Trials

    North Las Vegas, Nevada, 89030, United States

  • Life Clinical Trials

    Coral Springs, Florida, 33071, United States

  • Little Rock Allergy and Asthma Clinical Research Center

    Little Rock, Arkansas, 72205, United States

  • Long Beach Research Institute

    Long Beach, California, 90805, United States

  • McIntosh Clinic PC

    Thomasville, Georgia, 31792, United States

  • MedCare Pharma - Houston

    Houston, Texas, 77037, United States

  • Medical Advancement Centers of Arizona

    Tempe, Arizona, 85283, United States

  • Medical University of South Carolina

    Charleston, South Carolina, 29425, United States

  • Meridian International Research

    Miami Gardens, Florida, 33014, United States

  • MetroDerm / Atlanta Center for Clinical Research, LLC

    Atlanta, Georgia, 30342, United States

  • Nexus Clinical Research

    Homestead, Florida, 33033, United States

  • Northridge Clinical Trials

    Northridge, California, 91325, United States

  • Oakland Hills Dermatology

    Auburn Hills, Michigan, 48326, United States

  • Oregon Dermatology and Research Center

    Portland, Oregon, 97210, United States

  • Peninsula Research Associates

    Rolling Hills Estates, California, 90274, United States

  • Pioneer Clinical Research New York

    New York, New York, 10016, United States

  • Rochester Clinical Research Inc

    Rochester, New York, 14609, United States

  • Saint Jude Clinical Research

    Doral, Florida, 33172, United States

  • Scottsdale Clinical Trials

    Scottsdale, Arizona, 85260, United States

  • Sima recherche

    Verdun, Quebec, H4G 3E7, Canada

  • Skin Cancer and Dermatology Institute

    Reno, Nevada, 89509, United States

  • Skin Physicians Dermatology

    Edmonton, Alberta, T6W 4V4, Canada

  • Skincare Studio

    St. John's, Newfoundland and Labrador, A1E 1V4, Canada

  • Southern Indiana Clinical Trials

    New Albany, Indiana, 47150, United States

  • Stryde Research - Epiphany Dermatology

    Southlake, Texas, 76092, United States

  • Tanner Clinic

    Murray, Utah, 84107, United States

  • The Derm Institute of West Michigan

    Caledonia, Michigan, 49316, United States

  • The Skin Surgery Center

    Winston-Salem, North Carolina, 27103, United States

  • Tranquil Clinical Research

    Webster, Texas, 77598, United States

  • Tryon Medical Partners

    Matthews, North Carolina, 28105, United States

  • Unity Clinical Research

    Oklahoma City, Oklahoma, 73118, United States

  • University of California Los Angeles

    Los Angeles, California, 90024, United States

  • University of New Mexico Cancer Center

    Albuquerque, New Mexico, 87102, United States

  • Velocity Clinical Research Inc

    Medford, Oregon, 97504, United States

  • Visage Dermatology and Aesthetic Center

    Largo, Maryland, 20774, United States

  • Wake Research Medical Center for Clinical Research

    San Diego, California, 92120, United States

  • Wallace Medical Group Inc

    Los Angeles, California, 90056, United States

  • West Los Angeles Clinical Trials

    Los Angeles, California, 90067, United States

  • Wolverine Clinical Trials

    Tustin, California, 92780, United States

  • York Dermatology Centre

    Richmond Hill, Ontario, L4C 9M7, Canada

  • sms Clinical Research Limited Liability Company

    Mesquite, Texas, 75149, United States

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Other studies related to the condition(s) this trial covers.