Clinical Trials Register

Summary
EudraCT Number:	2021-001448-90
Sponsor's Protocol Code Number:	ANB019-302
National Competent Authority:	France - ANSM
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2021-10-05
Trial results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

France - ANSM

A.2

EudraCT number

2021-001448-90

A.3

Full title of the trial

A Phase 3, Long-Term Extension Study to Evaluate the Safety and Efficacy of Imsidolimab (ANB019) in
the Treatment of Adult Subjects with Generalized Pustular Psoriasis

Extension d’une étude clinique de phase III visant à évaluer l’efficacité et la tolérance à long terme de l’Imsidolimab (ANB019) dans le traitement de patients adultes atteints d’un Psoriasis Pustuleux Généralisé

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

A Phase 3, Long-Term Extension Study to Evaluate the Safety and Efficacy of Imsidolimab (ANB019) in
the Treatment of Adult Subjects with Generalized Pustular Psoriasis

A.3.2

Name or abbreviated title of the trial where available

Long-Term Safety and Efficacy of Imsidolimab in Subjects with Generalized Pustular Psoriasis

Sécurité et efficacité à long terme de l'Imsidolimab sur un Psoriasis Pustuleux Généralisé

A.4.1

Sponsor's protocol code number

ANB019-302

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	AnaptysBio Inc.
B.1.3.4	Country	United States
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	AnaptysBio Inc.
B.4.2	Country	United States
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	AnaptysBio Inc.
B.5.2	Functional name of contact point	AnaptysBio Clinical Trials Info
B.5.3	Address:
B.5.3.1	Street Address	10770 Wateridge Circle, Suite 210
B.5.3.2	Town/ city	San Diego, California
B.5.3.3	Post code	CA 92121
B.5.3.4	Country	United States
B.5.4	Telephone number	0018583626387
B.5.6	E-mail	clinicaltrialinfo@anaptysbio.com

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.2	Product code	ANB019
D.3.4	Pharmaceutical form	Solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use Subcutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	anti-IL-36R monoclonal antibody
D.3.9.2	Current sponsor code	ANB019
D.3.9.4	EV Substance Code	SUB33114
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	100
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	Yes
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Solution for injection
D.8.4	Route of administration of the placebo	Injection (Noncurrent)

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Subjects with generalized pustular psoriasis

Patients atteints d'un Psoriasis Pustuleux Généralisé

E.1.1.1

Medical condition in easily understood language

GPP is a severe, debilitating,and life-threatening systemic inflammatory disease.Skin lesions manifest with widespread sterile pustules on erythematous skin covering almost the entire body.

Le Psoriasis Pustuleux Généralisé est une maladie inflammatoire grave et potentiellement mortelle. Les lésions cutanées apparaissent sous forme de pustules non infectieuses couvrant tout le corps.

E.1.1.2

Therapeutic area

Diseases [C] - Skin and Connective Tissue Diseases [C17]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	PT
E.1.2	Classification code	10037575
E.1.2	Term	Pustular psoriasis
E.1.2	System Organ Class	10040785 - Skin and subcutaneous tissue disorders

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

To evaluate the long-term safety of imsidolimab in subjects with GPP who have participated in the ANB019-301 study

Évaluer la tolérance à long terme de l’imsidolimab chez des patients présentant un PPG et ayant participé à l’étude ANB019-301

E.2.2

Secondary objectives of the trial

To evaluate the long-term efficacy of imsidolimab in subjects with GPP who have participated in the ANB019-301 study

Évaluer l’efficacité à long terme de l’imsidolimab chez des patients présentant un PPG et ayant participé à l’étude ANB019-301

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Subject participated in the preceding placebo-controlled Phase 3 study ANB019-301, and
1) completed at least the Week 1 visit of the ANB019-301 study without the use of
rescue/prohibited medication for GPP and needed rescue medication starting at Week 1 or
later during the ANB019-301 study, or 2) completed the Week 4 visit of the ANB019-301
study, and did not need or use rescue/prohibited medication for GPP during his or her entire
participation in the ANB019-301 study.
NOTE: Subjects who did not need rescue/prohibited medication for GPP during their
participation in the ANB019-301 study will not be eligible for this study if they did not
complete the Week 4 visit of the ANB019-301 study.
2. Subject must be a candidate for prolonged GPP treatment according to the Investigator’s
judgment.
3. Subject has no clinically significant medical condition or physical/laboratory/ECG/vital
signs abnormality that would, in the opinion of the Investigator, put the subject at undue risk
or interfere with interpretation of study results.
4. Contraceptive use by men and women should be consistent with local regulations regarding
the methods of contraception for those participating in clinical studies.
Contraception and pregnancy:
a) A male subject who is sexually active with a female of childbearing potential and has
not had a vasectomy must agree to use contraception as detailed in Appendix 1 of this
protocol during the treatment period and for at least 220 days (which includes the
duration of relevant exposure plus the duration of sperm cycle) after the last study
treatment administration and refrain from donating sperm during this period.
b) Female subjects:
i) A woman of childbearing potential (WOCBP) is eligible to participate if she has a
negative urine pregnancy test at Day 1is not breastfeeding, and if
heterosexually active agrees to follow the contraceptive guidance during the treatment period and for at least 6 months after receiving the study
treatment, and refrains from donating oocytes for assisted reproduction during this
period. The female subject’s selected form of contraception must be effective by the
time the female subject enters into the study at Day 1 (eg, hormonal contraception
should be initiated at least 28 days before Day 1).
ii) A woman not of childbearing potential as defined in Appendix 1, must have a
follicle-stimulating hormone (FSH) test confirming nonchildbearing potential.
Follicle-stimulating hormone testing is not required as part of the present study if
already performed in the preceding study (data is available on file) and confirmed
nonchildbearing potential.
NOTE: If a female participant’s childbearing potential changes after start of the
study (eg, a woman who is not heterosexually active becomes heterosexually
active, a premenarchal woman experiences menarche), she must begin practicing a
highly effective method of birth control, as described above.
5. Subject is willing to participate and is capable of giving written informed consent, which
must be personally signed and dated by the subject and obtained prior to any study-related
activities.
6. Subject must be willing to comply with all study procedures and must be available for the
duration of the study.

E.4

Principal exclusion criteria

1. The following drugs or procedures are prohibited between the last visit of the ANB019-301
study and the Day 1 visit of the ANB019-302 study (if scheduled on separate days):
a) Imsidolimab, or other anti-IL-36R antibody.
b) Any topical with active ingredients that could have an effect on GPP (including, but not
limited to: corticosteroids, retinoids, vitamin A or D analog preparations, tacrolimus,
calcineurin inhibitor, topical H1 and H2 antihistamines, tar preparations, topical
antimicrobials, other medicated topical agents).
c) Any conventional systemic treatments that could have an effect on GPP (including, but
not limited to, corticosteroids [eg, oral, IV, intramuscular], retinoids [eg, acitretin,
alitretinoin], methotrexate, cyclosporin, fumaric acid esters, or any other
immunosuppressant or immunomodulation drugs).
NOTE: Intranasal corticosteroids and inhaled corticosteroids are allowed. Eye and ear
drops containing corticosteroids are also allowed.
d) Any ultraviolet B (UV-B) phototherapy (including tanning beds), excimer laser, or
psoralen and ultraviolet A (PUVA) treatment.
e) Any nonbiologic investigational drug.
f) Marketed or investigational biological agent.
g) Live and live-attenuated vaccines.
NOTE: Nonlive and nonlive-attenuated vaccines for COVID-19 (eg, ribonucleic acid
(RNA)-based vaccines, protein-based vaccines, and nonreplicating viral vector-based
vaccines) are allowed during the study.
2. Subject has any factor limiting the ability to cooperate and to comply with the study
protocol, as determined by the Investigator.
3. Subject is a pregnant or lactating woman, or a woman who intends to become pregnant
during the study period.
4. Subject has any other physical, mental, or medical conditions, which, in the opinion of the
Investigator, make study participation inadvisable or could confound study assessments.
5. Subject is not able to tolerate IV and/or SC drug administration.

E.5 End points

E.5.1

Primary end point(s)

Incidence of AEs, SAEs, and AEs leading to withdrawals, as well as changes in vital signs, clinical laboratory parameters (hematology, biochemistry, and urinalysis), and 12-lead ECGs

Incidence des EI, des EIG et des EI entraînant larrêt de l’étude, et variations dans les signes vitaux, les paramètres de biologie clinique (hématologie, biochimie, et examen des urines) et sur les ECG 12 dérivations

E.5.1.1

Timepoint(s) of evaluation of this end point

Week 4

Semaine 4

E.5.2

Secondary end point(s)

Proportion of subjects with zero recurrence of GPP flare (defined by a GPPPGA ≥ 3 [moderate] in subjects who had previously achieved a GPPPGA score of 0 [clear] or 1 [almost clear])
• Proportion of subjects in remission (defined by a GPPPGA score of 0 [clear] or 1 [almost clear]) at Week 24, without intake of any rescue medications during the treatment period
• Time to first GPP flare recurrence
• Proportion of subjects with a GPPPGA score of 0 (clear) or 1 (almost clear)
at each visit
• Proportion of subjects with a PRS score of 0 (clear) or 1 (almost clear) at each visit
• Time to first pustulation flare recurrence (defined by a PRS ≥ 3 [moderate]in subjects who had previously achieved a PRS score of 0 [clear] or 1 [almost clear])
• Proportion of subjects with a clinical response on the CGI scale at each visit. Clinical response is defined as “Very much improved,” “Much improved,” and “Minimally improved” on CGI scale according to the mJDA severity index total score
• Proportion of subjects losing clinical response on the CGI scale (defined as subjects who had previously achieved clinical response defined as “minimally improved” or better on CGI scale according to the mJDA severity index total score and worsen to either “no change” or “worsened” on the CGI scale) at each visit
• Change from Baseline in BSA affected with erythema with pustules as assessed by the mJDA severity index at each visit
• Percent change from Baseline in BSA affected with erythema with pustulesas assessed by the mJDA severity index at each visit
• Change from Baseline in BSA affected with total erythema as assessed by the mJDA severity index at each visit
• Percent change from Baseline in BSA affected with total erythema as assessed by the mJDA severity index at each visit
• Change from Baseline in BSA affected with edema as assessed by the mJDA severity index at each visit
• Percent change from Baseline in BSA affected with edema as assessed by the mJDA severity index at each visit
• Proportion of subjects with at least 3-point decrease from Baseline in pain NRS at each visit for subjects with a Baseline pain NRS of at least 3

• Proportion de patients sans poussée récurrente de PPG (définie par un score GPPPGA ≥ 3 [modéré] chez les sujets ayant précédemment obtenu un score GPPPGA de 0 [indemne] ou 1 [quasiment indemne])
• Proportion de patients en rémission (définie par un score GPPPGA de 0
[indemne] ou 1 [quasiment indemne]) à la Semaine 24, sans prise de traitement de secours pendant la période de traitement
• Délai jusqu’à la première poussée récurrente de PPG
• Proportion de patients ayant un score GPPPGA de 0 (indemne) ou 1 (quasiment indemne) à chaque visite
• Proportion de patients ayant un score PRS de 0 (absente) ou 1 (quasiment absente) à chaque visite
• Délai jusqu’à la première récurrence de poussée pustuleuse (définie par un score PRS ≥ 3 [modéré] chez les patients ayant précédemment obtenu un score PRS de 0 [absente] ou 1 [quasiment absente])
• Proportion de patients présentant une réponse clinique sur l’échelle CGI à chaque visite. La réponse clinique est définie par une « très forte amélioration », une « forte amélioration » et une « amélioration minimale » sur l’échelle CGI en fonction du score total de l’indice de sévérité mJDA
• Proportion de patients perdant la réponse clinique sur l’échelle CGI (définie par les patients ayant précédemment obtenu une réponse clinique définie par une « amélioration minimale » ou mieux sur l’échelle CGI en fonction du score total de l’indice de sévérité mJDA, et dont la réponse s’est dégradée en « absence de changement » ou « aggravation » sur l’échelle CGI) à chaque visite
• Variation par rapport à l’Inclusion de la BSA affectée par un érythème avec pustules, évaluée par l'indice de sévérité mJDA à chaque visite
• Variation en pourcentage par rapport à l’Inclusion de la BSA présentant un érythème avec pustules, évaluée par l’indice de sévérité mJDA à chaque visite
• Variation par rapport à l’Inclusion de la BSA présentant un érythème total, évaluée par l’indice de sévérité mJDA à chaque visite
•Variation en pourcentage par rapport à l’Inclusion de la BSA présentant un érythème total, évaluée par l’indice de sévérité mJDA à chaque visite
• Variation par rapport à l’Inclusion de la BSA présentant un œdème, évaluée par l'indice de sévérité mJDA à chaque visite
• Variation en pourcentage par rapport à l’Inclusion de la BSA présentant un œdème, évaluée par l'indice de sévérité mJDA à chaque visite
• Proportion de patients ayant une réduction d’au moins 3 points par rapport à l’Inclusion du score EN de douleur chez les sujets ayant un score initial de 3 minimum

E.5.2.1

Timepoint(s) of evaluation of this end point

Week 24

Semaine 24

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

Yes

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

Yes

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

Yes

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

Yes

E.8.5.1

Number of sites anticipated in the EEA

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.6.3

If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned

Australia

Georgia

Thailand

Korea, Republic of

Malaysia

Taiwan

E.8.7

Trial has a data monitoring committee

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

LVLS

Dernière visite du dernier patient

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.4.2

For a multinational trial

F.4.2.1

In the EEA

F.4.2.2

In the whole clinical trial

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

All subjects will return to the study site for the EOS (Day 225 [Week 32]) or ET visit for final safety and efficacy assessments. After this visit, subjects should be treated according to the clinical judgment of the subject’s physician. Any SAE or pregnancy occurring through the last planned visit should be reported to the pharmacovigilance unit (Section 8.2.1) and followed up until an outcome is determined

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2022-02-02

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2022-01-11

P. End of Trial
P.	End of Trial Status	Completed

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IMP with orphan designation in the indication
Orphan Designation Number:
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