To Assess the Efficacy and Safety of ANB019 in Subjects with Generalized Pustular Psoriasis

Phase 1

• Conditions: Generalized Pustular Psoriasis (GPP); MedDRA version: 21.0Level: LLTClassification code 10037159Term: Psoriasis pustularSystem Organ Class: 100000004858; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2017-004021-33-GB
• Lead Sponsor: AnaptysBio Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-12-20
• Study Completion: 2021-01-20
• Last Update Posted: 9 September 2024

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

1. Male and female subjects must be 18 to 75 years of age inclusive, at the time of signing the informed consent.
2. Have clinically confirmed diagnosis of active GPP.
3. Have a Japanese Dermatology Association severity index total score of >6 and must be present with active pustules and erythema accounting for at least 10% of BSA or have a GPPPGA score of at least moderate severity.
4. Must be candidates for systemic therapy or phototherapy as assessed by the Investigator.
5. Meet the following laboratory screening criteria:
a) Hemoglobin =90 g/L (=9 g/dL)
b) White blood cell count =3.0 × 109/L (=3.0 × 103/µL)
c) Platelets =100 × 109/L (=100 × 103/µL)
d) Serum creatinine <132.6 µmol/L (<1.5 mg/dL)
e) Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels =1.5 × upper limit of normal (ULN),
f) Total bilirubin =1.5 × ULN. Subjects with known Gilbert’s disease who have a serum bilirubin less than <3 × ULN may be enrolled
6. Body mass index (BMI) of 18 to 36 kg/m2, inclusive, {BMI = weight (kg)/[height (m)]2}, and total body weight > 50 kg (110 lb).
7. Subjects must be otherwise in a good health as judged by the Investigator based on medical history, physical examination, ECG, hematology, and chemistry laboratory parameters, and urinalysis.
8. Contraception and pregnancy:
a) A male subject must agree to use contraception 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 study treatment and refrain from donating sperm during this period.
b) Female subjects:
A female subject is eligible to participate if she has a negative serum pregnancy test (beta-human chorionic gonadotropin) at screening and a negative urine pregnancy test at Baseline, is not breastfeeding, and at least 1 of the following conditions apply:
i) Not a woman of childbearing potential (WOCBP).
OR
ii) A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 6 months after receiving the study treatment and refrain 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 (eg, hormonal contraception should be initiated at least 28 days before Day 1).
9. Capable of giving signed informed consent as described, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

1. Have other forms of psoriasis (eg, guttate) except plaque psoriasis.
2. Have concomitant dermatological (eg, subcorneal pustular dermatosis, impetigo herpetiformis, acute generalized exanthematous pustulosis) or medical conditions which may interfere with the Investigator’s ability to evaluate the subject’s response to therapy.
3. Have a history of clinically significant (as determined by the Investigator) cardiac, pulmonary, neurologic, gastrointestinal, endocrine, hematological, renal, hepatic, cerebral or psychiatric disease, or other major uncontrolled disease (a poorly controlled medical condition, such as but not limited to, poorly controlled diabetes, unstable ischemic heart disease, uncontrolled hypertension (systolic =160 mmHg and/or diastolic =95 mmHg based on the average of 2 blood tension measurements), and moderate to severe heart failure [New York Heart Association class III/IV]).
4. History of chronic or recurrent infectious disease, including but not limited to chest infection (eg, sinusitis, bronchitis, and bronchiectasis), urinary tract infection (eg, recurrent pyelonephritis), and skin infection (eg, abscesses, infected skin wounds, or ulcers) within 24 months prior to Screening.
5. History of a serious infection (eg, hepatitis, pneumonia) that led to hospitalization or treatment with IV antibiotics or antiviral treatment for an infection within 3 months prior to Screening or any recent infection requiring systemic antibiotic or systemic antiviral treatment within 4 weeks of Baseline.
6. History or any evidence of active infection within 4 weeks of Baseline (eg, bronchopulmonary, urinary, or gastrointestinal).
7. Presence of any factors that would predispose the subject to develop infection, eg, rectal fissures, poor dentition.
8. History of an opportunistic infection (eg, Pneumocystis carinii, aspergillosis, or mycobacteria other than tuberculosis [TB]), parasitic infections such as, but not exclusively, helminths, protozoa, Trypanosoma cruzi within 6 months of screening.
9. History of a herpes zoster infection within 2 months prior to screening.
10. Known or suspected autoimmune disorder, including but not limited to rheumatoid arthritis, fibromyalgia, systemic lupus erythematosus, polymyalgia rheumatica, giant cell arteritis, Behcet’s disease, dermatomyositis, multiple sclerosis, moderate to severe asthma, or other severe forms of atopy, any autoimmune vasculitis, autoimmune hepatitis, or any other active autoimmune disease for which a subject requires medical follow-up or medical treatment.
11. Any history of known or suspected congenital or acquired immunodeficiency state or condition that would compromise the subject’s immune status (eg, history of splenectomy).
12. Any major surgery within 4 weeks of study drug administration.
13. Malignancy or history of malignancy within 5 years, except for treated basal cell or squamous cell in situ carcinomas of the skin or squamous cell carcinomas deemed by the Principle Investigator to be fully treated.
14. History of any significant drug allergy or reaction (such as anaphylaxis or hepatotoxicity) and reactivity to polysorbate 20, a component of ANB019 formulation, or the inactive ingredients (excipients).
Have taken the following drugs within the specified period prior to Screening or:
a) Baseline: Topical medication (including corticosteroid, retinoids or vitamin A or D analog preparations, tacrolimus, calcineurin inhibitor, topical H1 and H2 antihistamines, tar pre

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified