A Study of Multiple Doses of AbGn-168H by Intravenous Infusion in Patients With Moderate to Severe Chronic Plaque Psoriasis
2016년 3월 15일 업데이트: AbGenomics B.V Taiwan Branch
Efficacy, Safety, Tolerability, and Pharmacokinetics of Multiple Doses of AbGn-168H Administered by Intravenous Infusion to Patients With Moderate to Severe Chronic Plaque Psoriasis (Randomised, Double-blind, Placebo-controlled)
This is a phase II, randomised, double-blind, placebo-controlled, multiple-dose, multi-center study of AbGn-168H in subjects with moderate to severe chronic plaque psoriasis.
The objectives of this study is to investigate efficacy, safety, tolerability, and pharmacokinetics (PK) of multiple doses of AbGn-168H administered intravenously to patients with moderate to severe chronic plaque psoriasis.
연구 개요
연구 유형
중재적
등록 (실제)
50
단계
- 2 단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Arizona
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Phoenix, Arizona, 미국, 85032
- Alliance Dermatology & MOHS Center, PC
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Arkansas
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Rogers, Arkansas, 미국, 72758
- Northwest AR Clinical Trials Center, PLLC.
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Florida
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Ocala, Florida, 미국, 34471
- Renstar Medical Research
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Port Orange, Florida, 미국, 32127
- Progressive Medical Research
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Tampa, Florida, 미국, 33609
- Progressive Medical Research
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Indiana
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Indianaopolis, Indiana, 미국, 46256
- DawesFretzin Clinical Research Group, LLC.
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New Jersey
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Berlin, New Jersey, 미국, 08009
- Comprehensive Clinical Research
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New York
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New York, New York, 미국, 10016
- Manhattan Medical Research Practice PLLC
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Rochester, New York, 미국, 14623
- Skin Search Of Rochester, Inc.
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North Carolina
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High Point, North Carolina, 미국, 27265
- High Point Clinical Trials Cente
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Raleigh, North Carolina, 미국, 27612
- Wake Research Associates
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Oklahoma
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Oklahoma City, Oklahoma, 미국, 73112
- Lynn Health Science Institute
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South Carolina
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Greer, South Carolina, 미국, 29650
- Radiant Research, Inc.
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Texas
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Katy, Texas, 미국, 77494
- Suzanne Bruce and Associates, P.A., The Center for Skin Research
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Utah
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Salt Lake City, Utah, 미국, 84132
- University of Utah Dermatology School of Medicine Dermatology 4A330
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion Criteria:
- Age 18 to 75 (inclusive), males or females
- Body weight < 140 kg
- Patients with stable moderate to severe plaque-type psoriasis, no significant changes within the past 6 months, involving ≥ 10% body surface area, with disease severity PASI ≥ 10 at screening visit and visit 2.
- Psoriasis disease duration of at least 6 months prior to screening
- Patients must be candidates for systemic psoriasis treatment or phototherapy
- Patient must give informed consent and sign an approved consent form prior to any study procedures
- Females of childbearing potential must have a negative pregnancy test result prior to enrollment and agree to use a highly effective method of birth control during the study. A highly effective method of birth control is defined as one which results in a low failure rate (less than 1% per year).
Exclusion Criteria:
- Patients with primary guttatae, erythrodermic, or pustular psoriasis and patients with drug-induced psoriasis
- Evidence of current or previous clinically significant disease, medical condition other than psoriasis, or finding of the medical examination (including vital signs and ECG), that in the opinion of the Investigator, would compromise the safety of the patient or the quality of the data. This criterion provides an opportunity for the investigator to exclude patients based on clinical judgment, even if other eligibility criteria are satisfied. (Psoriatic arthritis is not considered an exclusion)
- HIV infection or a known HIV-related Malignancy.
- Chronic or acute hepatitis B and C, or carrier status. Patient with anti-HBc Ab and undetectable anti-HBs Ab should also be excluded.
- Tuberculosis or a positive Tuberculin Skin Test (TST) for tuberculosis. Subjects previously received BCG vaccination or cannot receive TST can participate in the study after showing negative responses in Interferon-Gamma Release Assays (IGRA).
- History of malignancy in the past 5 years or suspicion of active malignant disease except treated cutaneous squamous cell or basal cell carcinoma and carcinoma in situ of the cervix uteri.
- History of allergy/hypersensitivity to a systemically administered biologic agent or its excipients
- Use of biologic agents or investigational drug within 8-12 weeks prior to treatment, systemic anti-psoriatic medications or phototherapy within 4 weeks prior to treatment, or topical anti-psoriasis medications (except emollients) within 2 weeks prior to treatment
- Intake of restricted medications or other drugs considered likely to interfere with the safe conduct of the study
- Current alcohol abuse
- Current drug abuse or positive drug screen at screening visit. Subjects with legitimate medically supervised uses of the drugs which are not excluded for other reasons can be enrolled.
- Any blood donation or significant blood loss within 4 weeks prior to Visit 2
- Excessive (e.g. competitive) physical activities (within 1 week prior to administration or during the trial)
Patients with any of the following laboratory values at screening and are considered clinically significant by the investigators:
- Haemoglobin, hematocrit, white blood cell count, absolute lymphocyte or neutrophil count, or platelet count < LLN (below the lower limit of the reference normal range)
- ALT, AST and/or total bilirubin > 2.5xULN
- Serum creatinine > 1.5x ULN
- Any clinically significant laboratory abnormalities other than those listed on Exclusion Criteria 14, based on the investigator's medical assessment at screening
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: AbGn-168H Low Dose
Subject to receive low dose of AbGn-168H intravenously
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AbGn-168H monoclonal antibody
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실험적: AbGn-168H High Dose
Subject to receive high dose of AbGn-168H intravenously
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AbGn-168H monoclonal antibody
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위약 비교기: Placebo
Subject to receive placebo intravenously
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Placebo of AbGn-168H
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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75% reduction in the Psoriasis Area Severity Index (PASI 75)
기간: at week 10
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The primary objective of this study is to investigate efficacy of AbGn-168H in patients with moderate to severe chronic plaque psoriasis following intravenous administration of multiple doses compared to placebo.
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at week 10
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Number of participants with abnormal Physical Examination finding
기간: At different time point for 20 weeks after the first treatment
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At different time point for 20 weeks after the first treatment
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Cmax
기간: 12 weeks after the first treatment
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Individual Cmax and tmax values will be directly determined from the plasma concentration time profiles of each subject
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12 weeks after the first treatment
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Number of participants with Vital Sign change
기간: At different time point for 20 weeks after the first treatment
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At different time point for 20 weeks after the first treatment
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Number of participants with abnormal ECG finding
기간: At different time point for 20 weeks after the first treatment
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At different time point for 20 weeks after the first treatment
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Number of participants with abnormal Clinical Laboratory parameters
기간: At different time point for 20 weeks after the first treatment
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blood chemistry, hematology and urinalysis
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At different time point for 20 weeks after the first treatment
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Number of participants with Adverse Event
기간: At different time point for 20 weeks after the first treatment
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At different time point for 20 weeks after the first treatment
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T1/2
기간: At different time point for 12 weeks after the first treatment
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At different time point for 12 weeks after the first treatment
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 연구 책임자: Shih-Yao Lin, MD, Ph.D, AbGenmics B.V. Taiwan Branch
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2014년 5월 1일
기본 완료 (실제)
2014년 12월 1일
연구 완료 (실제)
2015년 2월 1일
연구 등록 날짜
최초 제출
2014년 5월 22일
QC 기준을 충족하는 최초 제출
2014년 8월 21일
처음 게시됨 (추정)
2014년 8월 22일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2016년 4월 14일
QC 기준을 충족하는 마지막 업데이트 제출
2016년 3월 15일
마지막으로 확인됨
2016년 3월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .