Ichthyosis MedDRA version: 21.0 Level: LLT Classification code 10037159 Term: Psoriasis pustular System Organ Class: 100000004858
Conditions
Interventions
Product Name: Anti-interleukin-36 receptor (IL-36R) monoclonal antibody
Product Code: ANB019
Pharmaceutical Form: Solution for injection
INN or Proposed INN: anti-IL-36R monoclonal antibody
Current Sp
Sponsors
AnaptysBio Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male and female subject aged 12 to 75 years (inclusive) at the time of signing the informed consent/assent. 2. Confirmed diagnosis by genetic testing of ichthyosis of one of these subtypes: a) Congenital ichthyosiform erythroderma (autosomal recessive congenital ichthyosis [ARCI]); b) Epidermolytic ichthyosis; c) Netherton syndrome; d) Ichthyosis en confetti; e) Other subtypes may be included (only subtypes in which high levels of IL-36? expression in skin were confirmed by a ribonucleic acid [RNA] analysis [eg, RNA sequencing {RNA-seq}, polymerase chain reaction {PCR}] as part of other studies). Note: Confirmation of genetic subtype will be obtained prior to eligibility determination. 3. IASI total score = 18, erythema score = 2 (moderate severity) in = 1 body region and scaling score = 2 (moderate severity) in = 1 body region as evaluated by IASI, and BSA involved with ichthyosis of at least 50% at Day 1. 4. Subject has been using an emollient (without pharmacological active ingredients) daily for at least 1 week prior to Day 1 (except within 3 hours prior to the study visit) and agrees to continue using that same emollient daily at the same frequency throughout the study. 5. Subject meets the following laboratory criteria at screening: 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) = 2 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. 6. Body mass index (BMI) within the range of 18 to 38 kg/m2, inclusive {BMI = weight (kg)/[height (m)]2}. 7. 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. 8. 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 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 serum pregnancy test (beta-human chorionic gonadotropin) at screening and a negative urine pregnancy test at Day 1 (see Appendix 1), is not breastfeeding, and agrees to follow the contraceptive guidance in Appendix 1 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 48 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. iii) An adolescent subject who experiences menarche during the trial will be considered a WOCB
Exclusion criteria
Exclusion criteria: 1. Concomitant dermatological or medical conditions that may interfere with the Investigators’ ability to evaluate the subject’s response to therapy. 2. A subject with ichthyosis vulgaris, X-linked ichthyosis, or lamellar ichthyosis will be excluded. 3. Subject has a history of clinically significant cardiac, pulmonary, neurologic, gastrointestinal, endocrine, hematological, renal, hepatic, cerebral or psychiatric disease, or other major uncontrolled disease. 4. Chronic or recurrent infectious disease, including but not limited to upper and lower respiratory infection within 6 months prior to screening. 5. History or any evidence of active infection that required systemic treatment within 4 weeks of Day 1, excluding localized oral or genital herpes simplex that, in the opinion of the Investigator, is well-controlled. 6. Any factors that would predispose the subject to develop an infection in the Investigator’s opinion. 7. Opportunistic infection or parasitic infections within 6 months prior to screening. 8. Herpes zoster infection within 2 months prior to screening. 9. Known or suspected autoimmune disorder 10. History of known or suspected congenital or acquired immunodeficiency state, or condition that would compromise the subject’s immune status 11. Any major surgery within 4 weeks of Day 1. 12. History of cancer or lymphoproliferative disease within 5 years prior to Day 1. 13. History of any significant drug allergy or reaction and reactivity to polysorbate-20, a component of ANB019 formulation, or the inactive ingredients. 14. Subject has taken the following drugs within the specified period prior to Day 1: a) Topical medications within 2 weeks prior to Day 1. b) Topical agents or systemic agents that could affect pruritus within 2 weeks prior to Day 1. c) Oral sedative H1 antihistaminic (including but not limited to diphenhydramine) within 2 weeks prior to Day 1. d) Systemic therapy (including, but not limited to retinoids, cyclosporin, methotrexate, corticosteroids) or any other immunosuppressant or immunomodulation drugs within 4 weeks prior to Day 1. e) Previous treatment with anti-IL-36R, anti-IL-36, anti-tumor necrosis factor (TNF)/ IL-12/IL-23/ IL-17, or any other mAbs within 12 weeks or 5 half-lives (whichever is longer) prior to Day 1. f) Any nonbiologic investigational drug within 4 weeks or 5 half-lives, whichever is longer prior to Day 1. g) Marketed or investigational biological agent within 12 weeks or 5 half-lives (whichever is longer) prior to Day 1. h) Antibiotic medication within 4 weeks (topical 1 week and systemic 4 weeks) prior to Day 1. i) Systemic antiviral medication within 4 weeks prior to Day 1. j) Live attenuated vaccine within 12 weeks prior to Day 1. 15. Active TB or latent TB infection as indicated by a positive QuantiFERON®-TB Gold test at screening or within 6 months prior to screening (if the test is indeterminate, it can be repeated only once), chest X-ray, and/or clinical examination, or has had active TB disease at any time in the past. 16. 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. 17. Subject is a pregnant or lactating woman, or a woman who intends to become pregnant during the study period. 18. Subject has any other physical, mental, or medical conditions, which, in the opinion of the Investigator, make study participation inadvisable
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the effect of ANB019 compared with placebo as measured by IASI total score;Secondary Objective: • To evaluate the effect of ANB019 compared with placebo on ichthyosis signs and symptoms, and quality of life in subjects with ichthyosis. • To determine the safety of ANB019 in the treatment of ichthyosis. ;Primary end point(s): Change from baseline in IASI total score at Week 16;Timepoint(s) of evaluation of this end point: Week 16 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Percent change from Baseline in IASI total score at Week 16 - Proportion of subjects achieving IASI50 at Week 16 - Change and percent change from Baseline in IASI-E and IASI-S subscores at Week 16 - 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;Timepoint(s) of evaluation of this end point: Week 16 | — |
Countries
Canada, Poland, United States
Contacts
Public ContactAnaptysBio Clinical Trials Info
AnaptysBio Inc.
Outcome results
None listed