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2023-503522-40-01CompletedPhase 2

Efficacy and Safety of ANB032 in the Treatment of Subjects with Atopic Dermatitis

A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of ANB032 in the Treatment of Subjects with Moderate to Severe Atopic Dermatitis

Source: EU CTIS (euclinicaltrials.eu) · Last updated 22 Oct 2024

Brief summary (registry, in English)

To assess the clinical efficacy of ANB032 versus placebo in subjects with moderate to severe atopic dermatitis

Status (registry)
Completed
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
84 (actual)
First submitted
13 Nov 2023
Start date
10 Apr 2024
Lead sponsor
Anaptysbio Inc.
EU CT number
2023-503522-40-01

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 84
  • 18 sites in 2 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.

Who cannot take part

Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Not able to tolerate SC drug administration
  • Tanning booth use or extended sun exposure that could affect disease severity or interfere with disease assessments within 4 weeks before Randomization
  • Received or plans to initiate during the study any of the following prescribed medications or therapies: Systemic Janus kinase (JAK) inhibitors at any time prior to Day 1, Immunomodulatory biologic agents received within 12 weeks or 5 half lives (t1/2; whichever is longer) before Day 1, Phototherapy treatment or laser therapy that could affect disease severity or interfere with disease assessments within 4 weeks before Day 1, Systemic therapy for AD, including but not limited to, corticosteroids, methotrexate, cyclosporine, azathioprine, phosphodiesterase type 4 (PDE 4) inhibitors, IFN γ, and mycophenolate mofetil within 4 weeks before Day 1, Use of topical treatments for AD including but not limited to corticosteroids, tacrolimus, pimecrolimus, JAK inhibitors, or PDE-4 inhibitors within 14 days before Day 1, Live or live attenuated vaccines within 12 weeks before Day 1

Other illness

  • Any factors that in the Investigator's opinion would predispose the subject to develop an infection
  • Known or suspected congenital or acquired immunodeficiency state, or condition that would compromise the subject's immune status

Who the study is looking for

  • Male or female aged 18 to 65 years and in good general health
  • Moderate or severe atopic dermatitis continuously for at least 6 months prior to randomization
  • History of inadequate response to both topical corticosteroids and topical calcineurin inhibitors or for whom topical treatments are otherwise medically inadvisable
  • EASI score >=16 at Screening and at Randomization
  • vIGA-AD score >=3 at Screening and at Randomization
  • AD-involved BSA>=10% at Screening and at Randomization

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on EU CTIS (euclinicaltrials.eu)

Sites (18)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Pratia Pardubice a.s.
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PardubiceCzechiaCompleted
Clintrial s.r.o.
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Prague 10CzechiaCompleted
Praglandia s.r.o.
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Prague 5CzechiaCompleted
Prof. MUDr. Petr Arenberger, DrSc.
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Praha 1CzechiaCompleted
Vitamed Galaj i Cichomski sp.j.
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BydgoszczPolandCompleted
Diamond Clinic Sp. z o.o.
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CracowPolandCompleted
A-Derm-Serwis (NZOZ Przychodnia Specjalistyczna A-Derm-Serwis)
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CzęstochowaPolandCompleted
Uniwersyteckie Centrum Kliniczne
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GdanskPolandCompleted
Dermoklinika-Medyczne Centrum s.c. M.Kierstan J.Narbutt A.Lesiak
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LodzPolandCompleted
Uniwersytecki Szpital Kliniczny Im. Fryderyka Chopina W Rzeszowie
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RzeszówPolandCompleted
Clinmedica Research sp. z o.o.
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SkierniewicePolandCompleted
Tomasz Blicharski Lubelskie Centrum Diagnostyczne
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ŚwidnikPolandCompleted
Laser Clinic S.C. dr Tomasz Kochanowski dr Andrzej Królicki
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SzczecinPolandCompleted
Dorota Bystrzanowska High-Med. Przychodnia Specjalistyczna
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WarsawPolandCompleted
Etg Warszawa Sp. z o.o.
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WarsawPolandCompleted
Medicover Integrated Clinical Services Sp. z o.o.
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WarsawPolandCompleted
Cityclinic Przychodnia lekarsko psychologiczna Matusiak sp.p
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WroclawPolandCompleted
dermMedica Sp. z o.o
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WroclawPolandCompleted

This page is information, not medical advice. Discuss any trial with your doctor.