A Phase 2, Randomized, Placebo-controlled, Double-blind, Multiple Dose Study to Evaluate the Efficacy and Safety of ANB019 in Subjects with Palmoplantar Pustulosis
- Conditions
- Palmoplantar pustulosis (PPP)MedDRA version: 21.0Level: LLTClassification code 10037159Term: Psoriasis pustularSystem Organ Class: 100000004858Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Registration Number
- EUCTR2017-004022-15-DE
- Lead Sponsor
- AnaptysBio Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 59
1. Male and female subjects must be 18 to 75 years of age (inclusive), at the time of signing the informed consent.
2. Clinically confirmed diagnosis of PPP with disease of sufficient Impact and severity requiring systemic therapy.
3. Disease duration of at least 3 months prior to Screening.
4. Present with active pustules on palms or/and soles at Screening and Baseline.
5. At least moderate disease severity (score 3 = moderate) based on the PPPIGA (Appendix 9) at Screening.
6. Subjects with or without a history of plaque psoriasis can be enrolled (number of subjects enrolled with plaque psoriasis should not exceed 50%).
7. Meet the following laboratory criteria at Screening:
• Hemoglobin = 90 g/L (= 9 g/dL).
• White blood cell count = 3.0 × 10^9/L (= 3.0 × 10^3/µL).
• Platelets = 100 × 10^9/L (= 100 × 10^3/µL).
• Serum creatinine <132.6 µmol/L (< 1.5 mg/dL).
• Alanine aminotransferase (ALT) and aspartate aminotransferase (AST)
= 1.5 upper limit of normal (ULN),.
• Total bilirubin = 1.5 × ULN. Subjects with known Gilbert's disease who have serum bilirubin < 3 × ULN may be included.
8. Body mass index (BMI) within the range of 18 to 36 kg/m2, inclusive {BMI = weight (kg)/[height (m)]2} and total body weight > 50 kg (110 lb).
9. Subjects must be otherwise in a good health status as judged by the Investigator based on medical history, physical examination, ECG, hematology, chemistry,
and urinalysis.
10. Contraceptive use by men or 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 6 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 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 (see Appendix 6), is not breastfeeding, and at least 1 of the following conditions apply:
i) Not a woman of childbearing potential (WOCBP) as defined in Appendix 6.
OR
ii) A WOCBP who agrees to follow the contraceptive guidance in Appendix 6 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 48 days before
Day 1).
11. Capable of giving signed informed consent as described in Appendix 2, 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:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10
1. Have other forms of psoriasis (eg, erythrodermic, 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 Investigators' 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 (for definition of ranges see protocol) 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 upper and lower respiratory 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. Subjects with a history of localized oral or genital herpes simplex that, in the opinion of the Investigator, is well controlled will be eligible for study participation
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), excluding localized oral or genital herpes simplex that, in the opinion of the Investigator, is well-controlled
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 prior to 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, 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 treatment administration
13. Malignancy or history of malignancy within 5 years prior to Screening, except for treated basal cell or squamous cell in situ carcinoma of the skin or squamous cell carcinomas deemed by the Principal Investigator to be fully treatable
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method