Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ended
Participants planned
161
Countries
2
Sites
18
Atopic Dermatitis
To assess the clinical efficacy of ANB032 versus placebo in subjects with moderate to severe atopic dermatitis
Key facts
- Sponsor
- Anaptysbio Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Trial duration
- 10 Apr 2024 → 7 Jan 2025
- Decision date (initial)
- 2024-03-14
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- AnaptysBio
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Safety
To assess the clinical efficacy of ANB032 versus placebo in subjects with moderate to severe atopic dermatitis
Conditions and MedDRA coding
Atopic Dermatitis
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10003639 | Atopic dermatitis | 10040785 |
Regulatory references
- Plan to share IPD
- No
| EU CT number | Title | Sponsor |
|---|---|---|
| 2023-503522-40-00 | 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 | Anaptysbio Inc. |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 6
- 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 criteria 5
- 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
- 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
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Proportion of subjects who achieve ≥ 75% reduction (improvement) from Baseline in EASI (EASI-75) at Week 14
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD10314690 · Product
- Active substance
- ANB032
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 400 mg milligram(s)
- Max total dose
- 2400 mg milligram(s)
- Max treatment duration
- 12 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- ANAPTYSBIO, INC.
- Paediatric formulation
- No
- Orphan designation
- No
Placebo 1
Placebo solution for injection
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
Auxiliary 2
SCP29190199 · ATC
- Active substance
- Hydrocortisone
- Substance synonyms
- CORTISOL
- Route of administration
- CUTANEOUS USE
- Max daily dose
- 50 mg milligram(s)
- Max total dose
- 350 mg milligram(s)
- Max treatment duration
- 7 Day(s)
- Authorisation status
- Authorised
- ATC code
- H02AB09 — HYDROCORTISONE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP181101 · ATC
- Active substance
- Betamethasone Dipropionate
- Route of administration
- CUTANEOUS USE
- Max daily dose
- 1 mg milligram(s)
- Max total dose
- 7 mg milligram(s)
- Max treatment duration
- 7 Day(s)
- Authorisation status
- Authorised
- ATC code
- D07AB10 — ALCLOMETASONE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Anaptysbio Inc.
- Sponsor organisation
- Anaptysbio Inc.
- Address
- 10421 Pacific Center Court Suite 200
- City
- San Diego
- Postcode
- 92121-4339
- Country
- United States
Scientific contact point
- Organisation
- Anaptysbio Inc.
- Contact name
- Clinical Trial Info
Public contact point
- Organisation
- Anaptysbio Inc.
- Contact name
- Clinical Trial Info
Third parties 13
| Organisation | City, country | Duties |
|---|---|---|
| Champions Oncology ORL-000003658
|
Bresso, Italy | Laboratory analysis |
| Syneos Health Inc. ORG-100008382
|
Princeton, United States | Laboratory analysis |
| VeraSci ORL-000000971
|
Cary, United States | Other |
| Eurofins Pharma Bioanalytics Services US Inc. ORG-100049364
|
Saint Charles, United States | Laboratory analysis |
| Icahn School Of Medicine At Mount Sinai ORG-100011233
|
New York, United States | Laboratory analysis |
| Greenphire LLC ORG-100041621
|
King Of Prussia, United States | Other |
| Dokumeds SIA ORG-100034753
|
Riga, Latvia | On site monitoring, Code 12, Other, Code 5 |
| MedEvoke ORL-000003638
|
Lebanon, United States | Other |
| Everest Clinical Research Corporation ORG-100041734
|
Markham, Canada | Code 10, Code 11, Interactive response technologies (IRT), Data management |
| Linical Spain S.L. ORG-100009385
|
Las Rozas De Madrid, Spain | Code 8 |
| Clario ORL-000001148
|
Philadelphia, United States | Other |
| PCI Pharma Services Germany GmbH ORG-100031981
|
Großbeeren, Germany | Code 14 |
| Eurofins Central Laboratory B.V. ORG-100036990
|
Breda, Netherlands | Laboratory analysis |
Locations
2 EU/EEA countries · 18 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Czechia | Ended | 48 | 4 |
| Poland | Ended | 36 | 14 |
| Rest of world
New Zealand, Canada, United States, Georgia, Australia
|
— | 77 | — |
Investigational sites
Praglandia s.r.o.
NA, Ostrovskeho 253/3, Smichov, Prague 5
Clintrial s.r.o.
NA, Pocernicka 1427/16, Strasnice, Prague 10
Pratia Pardubice a.s.
NA, Trida Miru 2800, 53002, Pardubice
Prof. MUDr. Petr Arenberger, DrSc.
NA, Bolzanova 1604/7, 110 00, Praha 1
Vitamed Galaj I Cichomski Sp. j.
NA, Ul. Tadeusza Kosciuszki 35, 85-079, Bydgoszcz
Tomasz Blicharski Lubelskie Centrum Diagnostyczne
NA, Ul. Drewniana 61, 21-047, Swidnik
A-Derm-Serwis (NZOZ Przychodnia Specjalistyczna A-Derm-Serwis)
NA, ul. Waszyngtona 42/3, 42-200, Częstochowa
Etg Warszawa Sp. z o.o.
NA, Ul. Wynalazek 4, 02-677, Warsaw
Clinmedica Research Sp. z o.o.
NA, Ul. Ogrodowa 21/23, 96-100, Skierniewice
Dermmedica Sp. z o.o.
NA, Ul. Krzysztofa Kolumba 6, 51-503, Wroclaw
Uniwersyteckie Centrum Kliniczne
Department of Dermatology, Venerology and Allergology, Ul. Mariana Smoluchowskiego 17, 80-214, Gdansk
Dorota Bystrzanowska High Med Przychodnia Specjalistyczna
NA, Ul. Ulica Jana Kasprowicza 27/2, 01-817, Warsaw
Medicover Integrated Clinical Services Sp. z o.o.
Centrum Medyczne Warszawa, Ul Wronia 53 Lok B 10, 00-874, Warsaw
Uniwersytecki Szpital Kliniczny Im. Fryderyka Chopina W Rzeszowie
Klinika Dermatologii, Ul. Fryderyka Szopena 2, 35-055, Rzeszow
Cityclinic Przychodnia Lekarsko-Psychologiczna Matusiak sp.p.
NA, Ul. Ul. Sliczna 13, 50-566, Wroclaw
Dermoklinika-Medyczne Centrum s.c. M.Kierstan J.Narbutt A.Lesiak
NA, Al. Tadeusza Kosciuszki 93, 90-436, Lodz
Laser Clinic S.C. dr Tomasz Kochanowski dr Andrzej Królicki
NA, Al. Piastow 65/U5, 70-332, Szczecin
Diamond Clinic Sp. z o.o.
NA, Ul. Stefana Rogozinskiego 6/u11, 31-559, Cracow
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Czechia | 2024-04-10 | 2024-04-15 | 2024-06-05 | ||
| Poland | 2024-04-10 | 2024-04-15 | 2024-06-04 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Summary of results Art. 37(4) CTR
| Title | Submission date | Status | Type |
|---|---|---|---|
| Synoptic CSR_2023-503522-40-01 SUM-95824
|
2025-09-03T17:45:30 | Submitted | Summary of Results |
Layperson summary Annex V
| Title | Submission date | Status | Type |
|---|---|---|---|
| Layperson Summary Results_2023-503522-40-01 | 2025-09-03T17:45:42 | Submitted | Laypersons Summary of Results |
Documents 97 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Laypersons summary of results (for publication) | Layperson Summary Results_2023-503522-40-01_CZ | NA |
| Laypersons summary of results (for publication) | Layperson Summary Results_2023-503522-40-01_EN | NA |
| Laypersons summary of results (for publication) | Layperson Summary Results_2023-503522-40-01_PL | NA |
| Protocol (for publication) | D1_ANB032-201_Protocol_2023-503522-40_Redacted | 10.1 |
| Protocol (for publication) | Patient facing documents_questionnaire_DLQI_POL | 1 |
| Protocol (for publication) | Patient facing documents_questionnaire_DLQI_printscreen_POL | 1 |
| Protocol (for publication) | Patient facing documents_questionnaire_PaGIB-AD_POL | 1 |
| Protocol (for publication) | Patient facing documents_questionnaire_PaGIB-AD_printscreen_POL | 1 |
| Protocol (for publication) | Patient facing documents_questionnaire_PaGIC-AD_POL | 1 |
| Protocol (for publication) | Patient facing documents_questionnaire_PaGIC-AD_printscreen_POL | 1 |
| Protocol (for publication) | Patient facing documents_questionnaire_PaGIS-AD_POL | 1 |
| Protocol (for publication) | Patient facing documents_questionnaire_PaGIS-AD_printscreen_POL | 1 |
| Protocol (for publication) | Patient facing documents_questionnaire_POEM_POL | 1 |
| Protocol (for publication) | Patient facing documents_questionnaire_POEM_printscreen_POL | 1 |
| Protocol (for publication) | Patient facing documents_questionnaire_SSQ_POL | 1 |
| Protocol (for publication) | Patient facing documents_questionnaire_SSQ_printscreen_POL | 1 |
| Protocol (for publication) | Patient facing documents_scale_PNRS_POL | 1 |
| Protocol (for publication) | Patient facing documents_scale_PNRS_printscreen_POL | 1 |
| Protocol (for publication) | Patient facing documents_scale_SCORAD_POL | 1 |
| Protocol (for publication) | Patient facing documents_scale_SCORAD_printscreen_POL | 1 |
| Protocol (for publication) | Patient facing documents_Scale_SP-NRS_POL | 1.2 |
| Protocol (for publication) | Patient facing documents_scale_SP-NRS_printscreen_POL | 1 |
| Protocol (for publication) | Patient facing documents_scale_SSRS_POL | 1 |
| Protocol (for publication) | Patient facing documents_scale_SSRS_printscreen_POL | 1 |
| Recruitment arrangements (for publication) | K1_ANB032-201_Recruitment and informed consent procedure template_CZE | 2 |
| Recruitment arrangements (for publication) | K1_ANB032-201_Recruitment and informed consent procedure template_POL | 4.0 |
| Recruitment arrangements (for publication) | K2_ANB032-201_Recruitment material_5-Tab Flip Chart_CZE | 1 |
| Recruitment arrangements (for publication) | K2_ANB032-201_Recruitment material_5-Tab Flip Chart_POL | 2 |
| Recruitment arrangements (for publication) | K2_ANB032-201_Recruitment material_Banner Ads_FB and IG posts_CZE | 1 |
| Recruitment arrangements (for publication) | K2_ANB032-201_Recruitment material_Banner Ads_FB and IG posts_POL | 1 |
| Recruitment arrangements (for publication) | K2_ANB032-201_Recruitment material_Facebook Banner Ads_CZE | 1 |
| Recruitment arrangements (for publication) | K2_ANB032-201_Recruitment material_Facebook Banner Ads_POL | 1 |
| Recruitment arrangements (for publication) | K2_ANB032-201_Recruitment material_HCP to Patient Letter_CZE | 1 |
| Recruitment arrangements (for publication) | K2_ANB032-201_Recruitment material_HCP to Patient Letter_POL | 2 |
| Recruitment arrangements (for publication) | K2_ANB032-201_Recruitment material_Inclusion_Exclusion Card_CZE | 1 |
| Recruitment arrangements (for publication) | K2_ANB032-201_Recruitment material_Inclusion_Exclusion Card_POL | 1 |
| Recruitment arrangements (for publication) | K2_ANB032-201_Recruitment material_Patient Referral Website_CZE | 1 |
| Recruitment arrangements (for publication) | K2_ANB032-201_Recruitment material_Patient Referral Website_POL | 2 |
| Recruitment arrangements (for publication) | K2_ANB032-201_Recruitment material_Phone Script_CZE | 1 |
| Recruitment arrangements (for publication) | K2_ANB032-201_Recruitment material_Phone Script_POL | 1.1 |
| Recruitment arrangements (for publication) | K2_ANB032-201_Recruitment material_Recruitment Poster_CZE | 1 |
| Recruitment arrangements (for publication) | K2_ANB032-201_Recruitment material_Recruitment Poster_POL | 1 |
| Recruitment arrangements (for publication) | K2_ANB032-201_Recruitment material_Resource Guide_CZE | 1 |
| Recruitment arrangements (for publication) | K2_ANB032-201_Recruitment material_Resource Guide_POL | 2 |
| Recruitment arrangements (for publication) | K2_ANB032-201_Recruitment material_Tri-fold Brochure_CZE | 1 |
| Recruitment arrangements (for publication) | K2_ANB032-201_Recruitment material_Tri-fold Brochure_POL | 1 |
| Subject information and informed consent form (for publication) | L_ANB032-201_Patient facing document_Thank You Card_POL | 1.0 |
| Subject information and informed consent form (for publication) | L1_ANB032-201_Data privacy notification_Czech Rep_CZE | 2.0 |
| Subject information and informed consent form (for publication) | L1_ANB032-201_SIS and ICF_Main_Czech Rep_CZE_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_ANB032-201_SIS and ICF_Main_Poland_POL_Redacted | 5.0 |
| Subject information and informed consent form (for publication) | L1_ANB032-201_SIS and ICF_Optional Biobanking_Czech Rep_CZE | 2.0 |
| Subject information and informed consent form (for publication) | L1_ANB032-201_SIS and ICF_Optional Biobanking_Poland_POL | 2.0 |
| Subject information and informed consent form (for publication) | L1_ANB032-201_SIS and ICF_Optional Genetic Testing_Czech Rep_CZE | 2.0 |
| Subject information and informed consent form (for publication) | L1_ANB032-201_SIS and ICF_Optional Genetic Testing_Poland_POL | 2.0 |
| Subject information and informed consent form (for publication) | L1_ANB032-201_SIS and ICF_Optional Skin Biopsy_Czech Rep_CZE | 3.0 |
| Subject information and informed consent form (for publication) | L1_ANB032-201_SIS and ICF_Optional Skin Biopsy_Poland_POL | 2.0 |
| Subject information and informed consent form (for publication) | L1_ANB032-201_SIS and ICF_Pregnancy FU in subjects_Czech Rep_CZE | 2.0 |
| Subject information and informed consent form (for publication) | L1_ANB032-201_SIS and ICF_Pregnancy FU in subjects_Poland_POL | 2.0 |
| Subject information and informed consent form (for publication) | L1_ANB032-201_SIS and ICF_Pregnant Partner FU_Czech Rep_CZE | 3.0 |
| Subject information and informed consent form (for publication) | L1_ANB032-201_SIS and ICF_Pregnant Partner FU_Poland_POL | 2.0 |
| Subject information and informed consent form (for publication) | L1_ANB032-201_SIS and ICF_Reimbursement_Poland_POL | 1.0 |
| Subject information and informed consent form (for publication) | Patient facing documents_questionnaire_DLQI_CZE | NA |
| Subject information and informed consent form (for publication) | Patient facing documents_questionnaire_DLQI_printscreen_CZE | NA |
| Subject information and informed consent form (for publication) | Patient facing documents_questionnaire_PaGIB-AD_CZE | NA |
| Subject information and informed consent form (for publication) | Patient facing documents_questionnaire_PaGIB-AD_printscreen_CZE | NA |
| Subject information and informed consent form (for publication) | Patient facing documents_questionnaire_PaGIC-AD_CZE | NA |
| Subject information and informed consent form (for publication) | Patient facing documents_questionnaire_PaGIC-AD_printscreen_CZE | NA |
| Subject information and informed consent form (for publication) | Patient facing documents_questionnaire_PaGIS-AD_CZE | NA |
| Subject information and informed consent form (for publication) | Patient facing documents_questionnaire_PaGIS-AD_printscreen_CZE | NA |
| Subject information and informed consent form (for publication) | Patient facing documents_questionnaire_POEM_CZE | NA |
| Subject information and informed consent form (for publication) | Patient facing documents_questionnaire_POEM_printscreen_CZE | NA |
| Subject information and informed consent form (for publication) | Patient facing documents_questionnaire_SSQ_CZE | NA |
| Subject information and informed consent form (for publication) | Patient facing documents_questionnaire_SSQ_printscreen_CZE | NA |
| Subject information and informed consent form (for publication) | Patient facing documents_scale_PNRS_CZE | NA |
| Subject information and informed consent form (for publication) | Patient facing documents_scale_PNRS_printscreen_CZE | NA |
| Subject information and informed consent form (for publication) | Patient facing documents_scale_SCORAD_CZE | NA |
| Subject information and informed consent form (for publication) | Patient facing documents_scale_SCORAD_printscreen_CZE | NA |
| Subject information and informed consent form (for publication) | Patient facing documents_scale_SP-NRS_CZE | 1.2 |
| Subject information and informed consent form (for publication) | Patient facing documents_scale_SP-NRS_printscreen_CZE | NA |
| Subject information and informed consent form (for publication) | Patient facing documents_scale_SSRS_CZE | NA |
| Subject information and informed consent form (for publication) | Patient facing documents_scale_SSRS_printscreen_CZE | NA |
| Summary of results (for publication) | Adverse event listings_2023-503522-40-01_EN | NA |
| Summary of results (for publication) | Compliance and or drug concentration data_2023-503522-40-01_EN | NA |
| Summary of results (for publication) | Cover Letter Synopitic CSR_2023-503522-40-01_EN | NA |
| Summary of results (for publication) | Demographic data and other baseline characteristics_2023-503522-40-01_EN | NA |
| Summary of results (for publication) | Laboratory measurements_2023-503522-40-01_EN | NA |
| Summary of results (for publication) | Other clinical observations and measurements_2023-503522-40-01_EN | NA |
| Summary of results (for publication) | Protocols_2023-503522-40-01_EN | NA |
| Summary of results (for publication) | Section 14 tables and figures_2023-503522-40-01_EN | NA |
| Summary of results (for publication) | Signature of sponsors medical officer_2023-503522-40-01_EN | NA |
| Summary of results (for publication) | Statistical methods_2023-503522-40-01_EN | 1.0 |
| Summary of results (for publication) | Subjects excluded from analysis populations_2023-503522-40-01_EN | NA |
| Summary of results (for publication) | Synoptic CSR_2023-503522-40-01_EN | NA |
| Synopsis of the protocol (for publication) | D1_ANB032-201_Layperson Protocol synopsis CZE 2023-503522-40_Redacted | 2.0 |
| Synopsis of the protocol (for publication) | D1_ANB032-201_Layperson Protocol synopsis POL 2023-503522-40_Redacted | 2.0 |
| Synopsis of the protocol (for publication) | D1_ANB032-201_Protocol synopsis CZE 2023-503522-40_Redacted | 4.0 |
| Synopsis of the protocol (for publication) | D1_ANB032-201_Protocol synopsis POL 2023-503522-40_Redacted | 4.0 |
Application history
6 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-11-13 | Poland | No conclusion 2024-03-11
|
2024-03-13 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-04-17 | No conclusion | 2024-05-31 | |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-04-17 | Poland | No conclusion | 2024-05-27 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-06-05 | No conclusion | 2024-06-05 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2024-07-25 | Poland | Acceptable 2024-09-09
|
2024-09-11 |
| 6 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2024-10-22 | Acceptable 2024-09-09
|
2024-10-22 |