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

Phase 1

Conditions: Subjects with generalized pustular psoriasis
MedDRA version: 20.0Level: PTClassification code 10037575Term: Pustular psoriasisSystem Organ Class: 10040785 - Skin and subcutaneous tissue disorders
Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

Registration Number: EUCTR2021-001448-90-ES

Lead Sponsor: AnaptysBio Inc.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 45

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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 35
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this a

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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the long-term safety of imsidolimab in subjects with GPP who <br>have participated in the ANB019-301 study;Secondary Objective: To evaluate the long-term efficacy of imsidolimab in subjects with GPP <br>who have participated in the ANB019-301 study;Primary end point(s): Incidence of AEs, SAEs, and AEs leading to withdrawals, as well as <br>changes in vital signs, clinical laboratory parameters (hematology, <br>biochemistry, and urinalysis), and 12-lead ECGs;Timepoint(s) of evaluation of this end point: Week 4

Secondary Outcome Measures

Name	Time	Method

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