Clinical Trials Register

Summary
EudraCT Number:	2021-001447-27
Sponsor's Protocol Code Number:	ANB019-301
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2021-11-12
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

Spain - AEMPS

A.2

EudraCT number

2021-001447-27

A.3

Full title of the trial

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and
Safety of Imsidolimab (ANB019) in the Treatment of Adult Subjects with Generalized Pustular Psoriasis

A.3.1

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

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to
Evaluate the Efficacy and
Safety 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

Efficacy and Safety of Imsidolimab in Subjects with Generalized Pustular Psoriasis

A.4.1

Sponsor's protocol code number

ANB019-301

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	Infusion
D.8.4	Route of administration of the placebo	Infusion (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

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.

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 efficacy of imsidolimab compared with placebo in
subjects with GPP flare

E.2.2

Secondary objectives of the trial

To assess the safety of imsidolimab in subjects with GPP flare

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Male and female subject aged 18 to 80 years (inclusive) at the time of signing the informed
consent.
2. Subject has a known and documented history of GPP as per the European Rare and Severe
Psoriasis Expert Network GPP criteria confirmed by the Investigator based on review of medical records and/or medical history
OR subject is experiencing his/her first episode of GPP at the initial Screening, in which
case the GPP diagnosis must be confirmed by the Investigator.
-Subjects can enter Screening regardless of their current GPP severity. Subject may
have a GPP flare of moderate to severe intensity defined by a BSA affected with pustules
(excluding palms and soles)≥5%, a GPPPGA score≥3 (moderate severity), and a PRS
score≥3 (moderate severity) at the initial screening visit OR subject may have a GPPPGA
score≤ (mild severity) and/or a PRS score≤ 2mild severity) and/or BSA affected with
pustules (excluding palms and soles) <5%at the initial screening visit.
3.Subject has a BSA affected with pustules (excluding palms and soles) ≥ 5%, a GPPPGA
score ≥ 3 (moderate severity), and a PRS score ≥ 3 (moderate severity) at Day 1.
4.Subject meets the following laboratory criteria at Screening:
a) Hemoglobin ≥ 90 g/L (≥ 9 g/dL);
b) White blood cell count ≥ 2.8 × 109
/L (≥ 2.8 × 103
/µL);
c) Platelets ≥ 100 × 109
/L (≥ 100 × 103
/µL);
d)Serum creatinine < 132.6 µmol/L (< 1.5 mg/dL);
e)ALT or AST ≤ 3 × upper limit of normal (ULN);
f)Total bilirubin ≤ 1.5 × ULN. Subjects with known Gilbert’s disease who have serum
bilirubin < 3 × ULN may be included.
5.Subject has a body weight > 40 kg.
6.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.
7.Subject meets the following TB screening criteria:
a) Have no history of latent or active TB before Screening, with an exception for subjects
who have a history of latent TB that provide documentation of having completed
appropriate treatment for latent TB before the first administration of study drug. The
Investigator must verify the adequacy of previous anti-TB treatment based on current
local TB treatment guidelines and provide appropriate documentation.
b)Have no signs orsymptomssuggestive of active TB upon medical history and/or physical examination.
c)Have had no recent close contact with a person with active TB, based on information
provided by the subject.
d) Have a negative QuantiFERON®-TB test result obtained during Screening prior to
Day 1.
-However, a QuantiFERON®-TB test is not required at Screening for subjects
with a history of latent TB who have previously completed appropriate TB treatment
as described above in Inclusion Criterion 7a.
-A negative tuberculin skin test (as per local guidelines) may be required if the
QuantiFERON®-TB test is not approved/registered in that country or the tuberculin
skin test is mandated by local health authorities. If the tuberculin skin test is positive,
but is suspected to be a false positive, a confirmation by a specialist will be required to
exclude latent/active TB based on local guidelines.
e)A subject whose first screening QuantiFERON-TB® test result is indeterminate may
have the test repeated once.
8.Subject has the report from a qualified radiologist of a chest X-ray performed within
6 months before Day 1 that shows no abnormalities suggestive of a malignancy
or current active or latent infection, including TB. A chest CT scan is also
acceptable if already available. If not performed with 6 months before Day 1 a chest X-ray
must be performed at Screening.
9.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
b)Female subjects:
i)A woman of childbearing potential is eligible to participate if she has a
negative serum pregnancy test at Screening and a negative urine pregnancy test at Day 1 is 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
ii)A woman not of childbearing potential is eligible to participate if she meets the
criteria
10.Subject is willing to participate and is capable of giving written informed consent
11.Subject must be willing to comply with all study procedures

E.4

Principal exclusion criteria

1.Subject has other form of psoriasis ,except plaque psoriasis not previously described.
2.Subject has an immediately life-threatening flare of GPP in the Investigator’s opinion or
requires treatment in an intensive care unit.Life-threatening complications include, but are
not limited to,cardiovascular/cytokine-driven shock, pulmonary distress syndrome or renal
failure.
3.Subject has concomitant dermatological or medical conditions that may interfere with the
Investigators’ ability to evaluate the subject’s response to therapy.
4.Subject has a positive blood screen for hepatitis C antibody and hepatitis C ribonucleic acid
(RNA), antibodies to hepatitis B core antigen, hepatitis B surface antigen, or human
immunodeficiency virus 1 or 2 antibodies.
5.Subject has a history of clinically significant cardiac,
pulmonary, neurologic, gastrointestinal, endocrine, hematological, renal, hepatic, cerebral,
autoimmune, or psychiatric disease, or other major uncontrolled disease, which puts the
subject at undue risk for participation.
6.Subject has a history of chronic or recurrent infectious disease, including but not limited to
upper and lower respiratory infection ,urinary
tract infection.
7.Subject has a history or any evidence of an active bacterial, viral, or fungal infection (has
signs and/or symptoms of the infection and/or received antibiotic, antiviral, or antifungal
therapy for it) within 14 days prior to Day 1.
8.Subject has any factors that would predispose the subject to develop an infection in the
Investigator’s opinion
9.Subject has a history of an opportunistic infection or parasitic infections within 3 months prior to last Screening.
10.Subject has a history of a herpes zoster infection within 2 months prior to last Screening.
11.Subject has any history of known or suspected congenital or acquired immunodeficiency
state, or condition that would compromise the subject’s immune status
12.Subject had any major surgery within 4 weeks of Day 1.
13.Subject has a history of cancer or lymphoproliferative disease within 5 years prior to Day 1.
Subjects with successfully treated nonmetastatic cutaneous squamous cell or basal cell
carcinoma and/or localized carcinoma in situ of the cervix are not to be excluded.
14.Subject has a history of any significant drug allergy or reaction and reactivity to polysorbate-20, a component of imsidolimab formulation,
or the inactive ingredients
15.Prior treatment with imsidolimab, or other anti-IL-36R antibody.
16.For subjects with prior use of the following GPP therapies or procedures, the specified
washouts located in the Protocol between last dose of prohibited medication and Day 1 will apply
17. Receipt of any live or live-attenuated vaccines within 12 weeks of Day 1.
-Nonlive and nonlive-attenuated vaccines for COVID-19 are allowed
during the study.
18. Subject has a known history of clinically significant drug or alcohol abuse in the last year
prior to Day 1, or other factors limiting the ability to cooperate and to comply with the study
protocol, as determined by the Investigator.
19. Subject is a pregnant or lactating woman, or a woman who intends to become pregnant
during the study period.
20. Subject is not able to tolerate IV drug administration.
21. A subject who meets any of the following criteria will not be allowed to participate in biopsy
collection, but may still be eligible for the study

E.5 End points

E.5.1

Primary end point(s)

Proportion of subjects achieving a GPPPGA score of 0 (clear) or
1 (almost clear) at Week 4

E.5.1.1

Timepoint(s) of evaluation of this end point

Week 4

E.5.2

Secondary end point(s)

Key Secondary Efficacy Endpoint:
• Proportion of subjects achieving a PRS score of 0 (clear) or 1 (almost
clear) at Week 1
Additional Secondary Efficacy Endpoints:
• Proportion of subjects achieving at least a 2-grade decrease from
Baseline in GPPPGA score at Week 4
• Proportion of subjects achieving clinical response on the CGI scale at
Week 4. Clinical response is defined as “Very much improved,”
“Much improved,” and “Minimally improved” on the CGI scale
according to the mJDA severity index total score
• Change from Baseline in BSA affected with erythema with pustules as
assessed by the mJDA severity index at Week 1
• Percent change from Baseline in BSA affected with erythema with
pustules as assessed by the mJDA severity index at Week 1
Change from Baseline in BSA affected with erythema with pustules as
assessed by the mJDA severity index at Week 4
• Percent change from Baseline in BSA affected with erythema with
pustules as assessed by the mJDA severity index at Week 4
• Change from Baseline in BSA affected with total erythema as assessed
by the mJDA severity index at Week 4
• Percent change from Baseline in BSA affected with total erythema as
assessed by the mJDA severity index at Week 4
• Change from Baseline in BSA affected with edema as assessed by the
mJDA severity index at Week 4
• Percent change from Baseline in BSA affected with edema as assessed
by the mJDA severity index at Week 4
• Proportion of subjects achieving an improvement of 50% from
Baseline in GPPASI (GPPASI 50) at Week 4
• Proportion of subjects achieving an improvement of 75% from
Baseline in GPPASI (GPPASI 75) at Week 4
• Change from Baseline in DLQI at Week 4
• Change from Baseline in EQ-5D-5L at Week 4
• Proportion of subjects with at least a 3-point decrease from Baseline in
pain NRS at Week 4 for subjects with a Baseline pain NRS of at
least 3

E.5.2.1

Timepoint(s) of evaluation of this end point

Week 4

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

Korea, Republic of

Malaysia

Taiwan

Thailand

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

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 not rolling over into the long-term extension study ANB019-302 will return to the
study site for the Day 85 (Week 12) visit 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

2022-02-07

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2021-10-26

P. End of Trial
P.	End of Trial Status	Ongoing

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IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
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