Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a Phase IIa, 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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AbGn-168H Low Dose | Experimental | Subject to receive low dose of AbGn-168H intravenously |
|
| AbGn-168H: High Dose | Experimental | Subject to receive high dose of AbGn-168H intravenously |
|
| Placebo AbGn-168H | Placebo Comparator | Subject to receive placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AbGn-168H | Biological |
| ||
| placebo |
| Measure | Description | Time Frame |
|---|---|---|
| PASI75 | The primary objective of this study is to investigate efficacy (clinical proof of concept) of AbGn-168H in patients with moderate to severe chronic plaque psoriasis following intravenous administration of multiple doses compared to placebo. In this trial, the high dose and low dose of AbGn-168 and placebo is administered weekly. | the achievement of at least 75% reduction from baseline PASI score (PASI75) at week 12 in each patient. |
| Measure | Description | Time Frame |
|---|---|---|
| safety and tolerability | Safety measurements including physical examination, vital signs, ECG, clinical laboratory tests and adverse events | At different time point for 16 weeks after the first treatment |
| pharmacokinetics |
Not provided
Inclusion Criteria:
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 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 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 (c.f. Section 4.2.2) or other drugs considered likely to interfere with the safe conduct of the study
History of alcohol abuse
History of 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 (section 4.2.2 of the protocol) 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:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Shih-Yao Lin, MD, PhD | AbGenomics B.V Taiwan Branch | Study Director |
| Mark Lebwohl, MD | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baptist Health Certer for Clinical Research | Little Rock | Arkansas | 72205 | United States | ||
| Northwest AR Clinical Trials |
Not provided
Not provided
Not provided
Not provided
Not provided
| Biological |
|
AUC, Cmax, tmax, t1/2, MRT and Vss; additional parameters as needed
| At different time point for16 weeks after the first treatment |
| Rogers |
| Arkansas |
| 72758 |
| United States |
| Visions Clinical Research | Boynton Beach | Florida | 33472 | United States |
| Renstar Medical Research | Ocala | Florida | 34471 | United States |
| Progressive Medical Research | Orange | Florida | 32127 | United States |
| Olympian Clinical Research | Tampa | Florida | 33609 | United States |
| DawesFretzin Clinical Research Group, LLC. | Indianaopoli | Indiana | 46256 | United States |
| Indiana University Dermatology | Indianapolis | Indiana | 46202 | United States |
| Comprehensive Clinical Research | Berlin | New Jersey | 08009 | United States |
| University Urology Associates & Manhattan Research Associates | New York | New York | 10016 | United States |
| Mount Sinai School of Medicine | New York | New York | 10029 | United States |
| Research Affiliation | Oklahoma City | Oklahoma | 73112 | United States |
| Radiant Research, Inc. | Greer | South Carolina | 29650 | United States |
| Suzanne Bruce and Associates, The Center for Skin Research | Huston | Texas | 77056 | United States |
| West End Dermatology Assotiate | Richmond | Virginia | 23233 | United States |
| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided