Moderate to Severe Chronic Plaque PsoriasisPhase 2NCT02223039
A Study of Multiple Doses of AbGn-168H by Intravenous Infusion in Patients With Moderate to Severe Chronic Plaque Psoriasis
A Phase 2 study testing AbGn-168H in people with Moderate to Severe Chronic Plaque Psoriasis, run by AbGenomics B.V Taiwan Branch at 15 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Moderate to Severe Chronic Plaque Psoriasis
- What is being tested?
- AbGn-168H
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 15 sitesUnited States
- Study dates
- May 2014to Feb 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
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- 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
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
Comprehensive Clinical Research
Berlin, New Jersey, 08009
Radiant Research, Inc.
Greer, South Carolina, 29650
High Point Clinical Trials Cente
High Point, North Carolina, 27265
DawesFretzin Clinical Research Group, LLC.
Indianaopolis, Indiana, 46256
Suzanne Bruce and Associates, P.A., The Center for Skin Research
Katy, Texas, 77494
Manhattan Medical Research Practice PLLC
New York, New York, 10016
Renstar Medical Research
Ocala, Florida, 34471
Lynn Health Science Institute
Oklahoma City, Oklahoma, 73112
Alliance Dermatology & MOHS Center, PC
Phoenix, Arizona, 85032
Progressive Medical Research
Port Orange, Florida, 32127
Wake Research Associates
Raleigh, North Carolina, 27612
Skin Search of Rochester, Inc.
Rochester, New York, 14623
Northwest AR Clinical Trials Center, PLLC.
Rogers, Arkansas, 72758
University of Utah Dermatology School of Medicine Dermatology 4A330
Salt Lake City, Utah, 84132
Progressive Medical Research
Tampa, Florida, 33609
About this study
Official title: 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.
- Being tested
- AbGn-168H, Placebo
- Keywords
- Psoriasis, Dermatology, Monoclonal antibody
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AbGn-168HBiological
AbGn-168H monoclonal antibody
PlaceboBiological
Placebo of AbGn-168H
| Study group | Role | What they receive |
|---|---|---|
| AbGn-168H Low Dose | Experimental | Subject to receive low dose of AbGn-168H intravenously Receives: Biological: AbGn-168H |
| AbGn-168H High Dose | Experimental | Subject to receive high dose of AbGn-168H intravenously Receives: Biological: AbGn-168H |
| Placebo | Placebo comparator | Subject to receive placebo intravenously Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
75% reduction in the Psoriasis Area Severity Index (PASI 75)
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.
Measured: at week 10
Secondary outcomes (7)
Number of participants with abnormal Physical Examination finding
Measured: At different time point for 20 weeks after the first treatment
Cmax
Individual Cmax and tmax values will be directly determined from the plasma concentration time profiles of each subject
Measured: 12 weeks after the first treatment
Number of participants with Vital Sign change
Measured: At different time point for 20 weeks after the first treatment
Number of participants with abnormal ECG finding
Measured: At different time point for 20 weeks after the first treatment
Number of participants with abnormal Clinical Laboratory parameters
blood chemistry, hematology and urinalysis
Measured: At different time point for 20 weeks after the first treatment
Number of participants with Adverse Event
Measured: At different time point for 20 weeks after the first treatment
T1/2
Measured: At different time point for 12 weeks after the first treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2014 (estimated)
- Study startMay 2014
- Primary completionDec 2014
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Moderate to Severe Chronic Plaque PsoriasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbGenomics B.V Taiwan Branch
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shih-Yao Lin, MD, Ph.D, Study director, AbGenmics B.V. Taiwan BranchMark Lebwohl, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02223039
- Sponsor's protocol ID
- 2014.002.01
- Status last verified
- Mar 2016
- First submitted
- 22 May 2014
- Last updated
- 14 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT02223039
- Acronym / sponsor ID
- 2014.002.01
- Keywords
- Psoriasis, Dermatology, Monoclonal antibody
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- AbGenomics B.V Taiwan BranchIndustry (pharma, biotech, devices)
- Study start
- May 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 22 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| AbGn-168H Low Dose | Experimental | Biological: AbGn-168HSubject to receive low dose of AbGn-168H intravenously |
| AbGn-168H High Dose | Experimental | Biological: AbGn-168HSubject to receive high dose of AbGn-168H intravenously |
| Placebo | Placebo comparator | Biological: PlaceboSubject to receive placebo intravenously |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (18 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AbGn-168HAbGn-168H monoclonal antibody | Biological | AbGn-168H High Dose, AbGn-168H Low Dose |
| PlaceboPlacebo of AbGn-168H | Biological | Placebo |
Primary outcome
75% reduction in the Psoriasis Area Severity Index (PASI 75)
Time frame: at week 10
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.
7 secondary outcomes
Number of participants with abnormal Physical Examination finding
Time frame: At different time point for 20 weeks after the first treatment
Cmax
Time frame: 12 weeks after the first treatment
Number of participants with Vital Sign change
Time frame: At different time point for 20 weeks after the first treatment
Number of participants with abnormal ECG finding
Time frame: At different time point for 20 weeks after the first treatment
Number of participants with abnormal Clinical Laboratory parameters
Time frame: At different time point for 20 weeks after the first treatment
Number of participants with Adverse Event
Time frame: At different time point for 20 weeks after the first treatment
T1/2
Time frame: At different time point for 12 weeks after the first treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shih-Yao Lin, MD, Ph.D study director
AbGenmics B.V. Taiwan Branch
Mark Lebwohl, MD principal investigator
Icahn School of Medicine at Mount Sinai
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AbGn-168H in people with Moderate to Severe Chronic Plaque Psoriasis, run by AbGenomics B.V Taiwan Branch at 15 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
75% reduction in the Psoriasis Area Severity Index (PASI 75) (time frame: at week 10). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2016.