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

2023-503522-40-00 Protocol ANB032-201 Therapeutic exploratory (Phase II) Not authorised

Status Not authorised · 2 EU/EEA countries · 15 sites · Protocol ANB032-201

Overview

Sponsor-declared trial summary

Phase Therapeutic exploratory (Phase II)
Status Not authorised
Participants planned 160
Countries 2
Sites 15

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
Gender
Male and Female
Therapeutic area
Diseases [C] - Skin and Connective Tissue Diseases [C17]
Decision date (initial)
2023-09-12
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

VersionLevelCodeTermSystem organ class
21.1 LLT 10003639 Atopic dermatitis 10040785

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

  1. Male or female aged 18 to 65 years and in good general health
  2. Moderate or severe atopic dermatitis for at least 6 months prior to randomization
  3. History of inadequate response to treatment for atopic dermatitis with topical medications or for whom topical treatments are otherwise medically inadvisable
  4. EASI score >=16 at Screening and at Randomization
  5. vIGA-AD score >=3 at Screening and at Randomization
  6. AD-involved BSA>=10% at Screening and at Randomization

Exclusion criteria 5

  1. Any factors that in the Investigator's opinion would predispose the subject to develop an infection
  2. Known or suspected congenital or acquired immunodeficiency state, or condition that would compromise the subject's immune status
  3. Not able to tolerate SC drug administration
  4. Tanning booth use or extended sun exposure that could affect disease severity or interfere with disease assessments within 4 weeks before Randomization
  5. 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

  1. Mean change from Baseline in Eczema Area and Severity Index (EASI) at Week 14

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

ANB032

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 matching IMP

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

Alclometasone Dipropionate

SCP268860 · ATC

Active substance
Alclometasone 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

Hydrocortisone

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

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Anaptysbio Inc.

5 Total trials 1 Recruiting 3 Ended
Commercial
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 8

OrganisationCity, countryDuties
Dokumeds SIA
ORG-100034753
 Riga, Latvia On site monitoring, Code 12, Other, Code 5
Eurofins Central Laboratory B.V.
ORG-100036990
 Breda, Netherlands Laboratory analysis
Everest Clinical Research Corporation
ORG-100041734
 Markham, Canada Code 10, Code 11, Interactive response technologies (IRT), Data management
VeraSci
ORL-000000971
 Cary, United States Other
Linical Spain S.L.
ORG-100009385
 Las Rozas De Madrid, Spain Code 8
PCI Pharma Services Germany GmbH
ORG-100031981
 Großbeeren, Germany Code 14
Clario
ORL-000001148
 Philadelphia, United States Other
Greenphire LLC
ORG-100041621
 King Of Prussia, United States Other

Locations

2 EU/EEA countries · 15 investigational sites

By country

CountryMS statusPlanned subjectsSites
Czechia Not authorised 24 5
Poland Not authorised 36 10
Rest of world
United States, Canada
 — 100 —

Investigational sites

Czechia

5 sites · Not authorised
Prof. MUDr. Petr Arenberger, DrSc.
NA, Bolzanova 1604/7, 110 00, Praha 1
Clintrial s.r.o.
NA, Pocernicka 1427/16, Strasnice, Prague 10
CCR Czech a.s.
NA, Trida Miru 2800, 53002, Pardubice
CCR Prague s.r.o.
NA, Vinohradska 1597/174, Vinohrady, Prague 3
Praglandia s.r.o.
NA, Ostrovskeho 253/3, Smichov, Prague 5

Poland

10 sites · Not authorised
Diamond Clinic Sp. z o.o.
NA, Ul. Stefana Rogozinskiego 6/u11, 31-559, Cracow
Cityclinic Przychodnia Lekarsko-Psychologiczna Matusiak sp.p.
NA, Ul. Ul. Sliczna 13, 50-566, Wroclaw
Centrum Badan Klinicznych Pi-House Sp. z o.o.
NA, Ul. Na Zaspe 3, 80-546, Gdansk
Dorota Bystrzanowska High­ Med Przychodnia Specjalistyczna
NA, Ul. Ulica Jana Kasprowicza 27/2, 01-817, Warsaw
Dermedic Jacek Zdybski
NA, Sienkiewicza 65/14/II, 27-400, Ostrowiec Swietokrzyski
Tomasz Blicharski Lubelskie Centrum Diagnostyczne
NA, Ul. Drewniana 61, 21-047, Swidnik
Uniwersyteckie Centrum Kliniczne
Department of Dermatology, Venerology and Allergology, Ul. Mariana Smoluchowskiego 17, 80-214, Gdansk
Uniwersytecki Szpital Kliniczny Im. Fryderyka Chopina W Rzeszowie
Klinika Dermatologii, Ul. Fryderyka Szopena 2, 35-055, Rzeszow
Medicover Integrated Clinical Services Sp. z o.o.
Centrum Medyczne Warszawa, Ul Wronia 53 Lok B 10, 00-874, Warsaw
Dermoklinika-Medyczne Centrum s.c. M.Kierstan J.Narbutt A.Lesiak
NA, Al. Tadeusza Kosciuszki 93, 90-436, Lodz

Application history

1 submissions — initial application plus substantial / non-substantial modifications

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2023-05-18 Poland Not acceptable
2023-09-11
 2023-09-12

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