Efficacy and Safety of ANB032 in the Treatment of Subjects with Atopic Dermatitis
Key facts
- Where
- Bydgoszcz, Cracow, Częstochowa, Gdansk, Lodz, Rzeszów, Skierniewice, Świdnik, Szczecin, Warsaw és Wroclaw, LengyelországSee the 14 sites
- Phase
- 2. fázis
Where in Lengyelország
- Vitamed Galaj i Cichomski sp.j.Bydgoszcz, LengyelországNo longer taking part
- Diamond Clinic Sp. z o.o.Cracow, LengyelországNo longer taking part
- A-Derm-Serwis (NZOZ Przychodnia Specjalistyczna A-Derm-Serwis)Częstochowa, LengyelországNo longer taking part
- Uniwersyteckie Centrum KliniczneGdansk, LengyelországNo longer taking part
- Dermoklinika-Medyczne Centrum s.c. M.Kierstan J.Narbutt A.LesiakLodz, LengyelországNo longer taking part
- Uniwersytecki Szpital Kliniczny Im. Fryderyka Chopina W RzeszowieRzeszów, LengyelországNo longer taking part
- Clinmedica Research sp. z o.o.Skierniewice, LengyelországNo longer taking part
- Tomasz Blicharski Lubelskie Centrum DiagnostyczneŚwidnik, LengyelországNo longer taking part
- Laser Clinic S.C. dr Tomasz Kochanowski dr Andrzej KrólickiSzczecin, LengyelországNo longer taking part
- Dorota Bystrzanowska High-Med. Przychodnia SpecjalistycznaWarsaw, LengyelországNo longer taking part
- Etg Warszawa Sp. z o.o.Warsaw, LengyelországNo longer taking part
- Medicover Integrated Clinical Services Sp. z o.o.Warsaw, LengyelországNo longer taking part
- Cityclinic Przychodnia lekarsko psychologiczna Matusiak sp.pWroclaw, LengyelországNo longer taking part
- dermMedica Sp. z o.oWroclaw, LengyelországNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Anaptysbio Inc.
- Trial code
- EU 2023-503522-40-01
- Record updated
- 2024. október 22.
- Original description
To assess the clinical efficacy of ANB032 versus placebo in subjects with moderate to severe atopic dermatitisRead full original descriptionShow less
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
To assess the clinical efficacy of ANB032 versus placebo in subjects with moderate to severe atopic dermatitis
Inclusion: 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.
Exclusion: 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; 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.