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.
- Diseases
- Atopic dermatitis (eczema)
- 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
Sites (18)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Pratia Pardubice a.s. Coordinator of this site? Confirm its status | Pardubice | Czechia | Completed |
| Clintrial s.r.o. Coordinator of this site? Confirm its status | Prague 10 | Czechia | Completed |
| Praglandia s.r.o. Coordinator of this site? Confirm its status | Prague 5 | Czechia | Completed |
| Prof. MUDr. Petr Arenberger, DrSc. Coordinator of this site? Confirm its status | Praha 1 | Czechia | Completed |
| Vitamed Galaj i Cichomski sp.j. Coordinator of this site? Confirm its status | Bydgoszcz | Poland | Completed |
| Diamond Clinic Sp. z o.o. Coordinator of this site? Confirm its status | Cracow | Poland | Completed |
| A-Derm-Serwis (NZOZ Przychodnia Specjalistyczna A-Derm-Serwis) Coordinator of this site? Confirm its status | Częstochowa | Poland | Completed |
| Uniwersyteckie Centrum Kliniczne Coordinator of this site? Confirm its status | Gdansk | Poland | Completed |
| Dermoklinika-Medyczne Centrum s.c. M.Kierstan J.Narbutt A.Lesiak Coordinator of this site? Confirm its status | Lodz | Poland | Completed |
| Uniwersytecki Szpital Kliniczny Im. Fryderyka Chopina W Rzeszowie Coordinator of this site? Confirm its status | Rzeszów | Poland | Completed |
| Clinmedica Research sp. z o.o. Coordinator of this site? Confirm its status | Skierniewice | Poland | Completed |
| Tomasz Blicharski Lubelskie Centrum Diagnostyczne Coordinator of this site? Confirm its status | Świdnik | Poland | Completed |
| Laser Clinic S.C. dr Tomasz Kochanowski dr Andrzej Królicki Coordinator of this site? Confirm its status | Szczecin | Poland | Completed |
| Dorota Bystrzanowska High-Med. Przychodnia Specjalistyczna Coordinator of this site? Confirm its status | Warsaw | Poland | Completed |
| Etg Warszawa Sp. z o.o. Coordinator of this site? Confirm its status | Warsaw | Poland | Completed |
| Medicover Integrated Clinical Services Sp. z o.o. Coordinator of this site? Confirm its status | Warsaw | Poland | Completed |
| Cityclinic Przychodnia lekarsko psychologiczna Matusiak sp.p Coordinator of this site? Confirm its status | Wroclaw | Poland | Completed |
| dermMedica Sp. z o.o Coordinator of this site? Confirm its status | Wroclaw | Poland | Completed |
This page is information, not medical advice. Discuss any trial with your doctor.