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New shot shows promise for tough eczema cases

NCT ID NCT05932654

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study tested an experimental drug called BSI-045B in 22 adults with moderate to severe atopic dermatitis (eczema). Participants received injections weekly for 4 weeks, then every 2 weeks up to 24 weeks. The main goals were to see if the drug safely reduces eczema severity by at least 75% and to monitor side effects.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

22 people

The number who actually took part.

Started

Jul 2023

Finished

Sep 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 65 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.

Main inclusion Criteria: * In the opinion of the Investigator, the patient is capable of understanding and complying with protocol requirements. * The patient signs and dates a written ICF prior to the initiation of any study procedures. * The patient has a diagnosis of AD (according to the criteria established by Hanifin and Rajka, 1980). The diagnosis of AD must have been present for at least 1 year, and the patient's AD must have been active for at least 3 months. * The patient is aged 18 to 65 years, inclusive at the time of consent. Patients of any gender are eligible. * The EASI is ≥12 at Screening and on Day 1. * The score on the IGA is ≥3 (scale of 0 to 4) at Screening and on Day 1. * The total body surface area (BSA) affected by AD is ≥10% as assessed by the physical examination at Screening and on Day -1. * The patient has not received prior treatment with topical or systemic medications OR the patient has active disease despite topical or systemic treatment as per the Investigator at the time of screening. * A male patient who is non-sterilized and sexually active with a female partner of childbearing potential, and female patient of childbearing potential who is sexually active with a non-sterilized male partner agrees to use highly effective contraception from the time of signing the ICF throughout the duration of the study and for 90 days (\~5 half lives) after the last dose of study drug. Main Exclusion Criteria: * The patient has another dermatologic condition that might confound a diagnosis of AD or a treatment assessment. * The patient has any clinically significant illness that may affect the safety, increase the risk for seizure or lower the seizure threshold, or potentially confound the study results. * The patient has abnormal laboratory values during the Screening Period: ALT and/or AST \> 1.5 ULN, total bilirubin ≥ 1.5 mg/dL, estimated glomerular filtration rate (GFR) \< 60 mL/min (based on Cockcroft-Gault calculation), hemoglobin≤ 10 g/dL, platelet count ≤ 150 ×103/µL, creatine kinase \> 2.5×ULN. * The patient has a history of anaphylaxis following biologic therapy. * The patient has a history of allergy to corticosteroids, diphenhydramine, hydroxyzine, cetirizine, or fexofenadine. * The patient has a history of a clinically significant infection within 4 weeks prior to Screening. * The patient has been diagnosed with a helminthic parasitic infection within 6 months prior to Screening. * The patient has a history of drug abuse (defined as any illicit drug use) or a history of alcohol abuse within 1 year prior to Screening or is unwilling to agree to abstain from alcohol and drugs (including cannabinoids) throughout the study. * The patient had a major surgical or major dental procedure within 8 weeks prior to Screening. * The patient is pregnant or lactating or intends to become pregnant or donate ova before, during, or within 90 days (\~ 5 half-lives) since the last dose of study drug. * If male, the patient intends to donate sperm during this study or within 90 days (\~ 5 half-lives) since the last dose of study drug. * The patient has a history of neurologic abnormalities including abnormal electroencephalography, brain injury including traumatic injury, perinatal cerebropathy, postnatal brain damage, blood-brain barrier abnormality, and cavernous angioma. * The patient has a history of cerebral arteriosclerosis. * The patient has a history of cancer. Patients with localized basal cell carcinoma, localized squamous cell carcinoma of the skin, or carcinoma in situ of the cervix may be included in the study if they have completed curative treatment at least 12 months prior to Screening. Patients with other malignant tumors may be included if they have completed curative treatment at least 5 years prior to the first dose of study drug. * The patient has a positive test result for hepatitis B surface antigen (HbsAg), antihepatitis C virus (HCV), a history of active tuberculosis, a positive test result for human immunodeficiency virus (HIV), or a known history of HIV infection at Screening. * The patient has poor peripheral venous access. * The patient has donated or lost ≥ 450 mL of blood (including plasmapheresis) or had a transfusion of any blood product within 90 days prior to the first dose of study drug. * The patient has an abnormal ECG at Screening or on Day -1. In the case of a corrected QT interval (Fridericia) (QTcF) \> 450 ms or \> 470 ms (patients with bundle branch block) or PR interval outside the range of 115 to 220 ms, assessment may be repeated once for eligibility determination at Screening and/or on Day -1. * The patient has a supine systolic blood pressure \< 90 or \> 144 mm Hg or a supine diastolic blood pressure \< 50 or \> 94 mm Hg at Screening or on Day -1. If out of range, assessment may be repeated once for eligibility determination at Screening and/or on Day -1. * The patient has a resting heart rate \< 40 or \> 90 bpm (not on ECGs) and considered clinically significant by the Investigator at Screening or on Day 1. If out of range, the assessment may be repeated once for eligibility determination at Screening and/or on Day -1. * The patient plans to use any other prohibited medication or undergo any prohibited procedure during the study. Oral antibiotics are permitted. Bleach baths are not permitted. * The patient has a risk of suicide on the Patient Health Questionnaire-2 (PH 2) or in the judgment of the Investigator, or the patient has made a suicide attempt or has a history of deliberate self-harm in the 6 months prior to Screening. * The patient is compulsorily detained for a medical or psychiatric illness. * The patient or their immediate family are personnel at the clinical site. * The patient is unable to comply with restrictions and prohibited activities/treatments as listed in the study protocol.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Accellacare - Cary

    Cary, North Carolina, 27518, United States

  • Accellacare - Raleigh

    Raleigh, North Carolina, 27609, United States

  • Accellacare-Wilmington

    Wilmington, North Carolina, 28411, United States

  • Advanced Medical Research - Medical Dermatology Specialists

    Sandy Springs, Georgia, 30328, United States

  • Allcutis Research - Beverly, MA

    Beverly, Massachusetts, 01915, United States

  • Beacon Clinical Research

    Quincy, Massachusetts, 02169, United States

  • Center for Clinical Studies - Webster

    Webster, Texas, 77598, United States

  • Center for Dermatology Clinical Research

    Fremont, California, 94538, United States

  • Dawes Fretzin Clinical Research

    Indianapolis, Indiana, 46250, United States

  • Dermatology Specialists of Spokane

    Spokane, Washington, 99202, United States

  • First OC Dermatology - Fountain Valley

    Fountain Valley, California, 92708, United States

  • Paddington Testing Company

    Philadelphia, Pennsylvania, 19103, United States

  • Profound Research LLC - Nashville - Corporate

    Oceanside, California, 92056, United States

  • Sadick Research Group

    New York, New York, 10075, United States

  • Skin Sciences/Derm Research Pllc.

    Louisville, Kentucky, 40217, United States

  • The George Washington University School of Medicine and Health Science

    Washington D.C., District of Columbia, 20037, United States

  • Wright State Physicians Health Center

    Fairborn, Ohio, 45324, United States

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