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Psoriatic ArthritisPhase 2NCT02267642

A Phase II Study Evaluating the Efficacy and Safety of AbGn-168H in Patients With Active Psoriatic Arthritis

A Phase 2 study testing AbGn-168H in people with Psoriatic Arthritis, run by AbGenomics B.V Taiwan Branch at 7 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To evaluate efficacy, safety, tolerability, and immunogenicity of AbGn-168H administered intravenously in patients with active psoriatic arthritis. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Psoriatic Arthritis
What is being tested?
AbGn-168H
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
7 sitesUnited States
Study dates
Jan 2015to Jan 2016
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

  • Patient must give informed consent and sign an approved consent form prior to any study procedures
  • Age 18 to 75 (inclusive), males or females
  • Body weight < 140 kg
  • Subject has had a diagnosis of psoriatic arthritis for at least 6 months and currently meets the CASPAR criteria.
  • Patients must have moderate to severe active PsA at screening and baseline, defined as having greater than or equal to 3 tender (out of 68) and 3 swollen (out of 66) joints.
  • Patients must have at least one evaluable skin plaque, 2 cm in diameter, that can be followed with a target lesions score (scalp and groin lesions cannot be used), or documented psoriasis history.
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  • Patients must have history of inadequate response or intolerance to NSAID or DMARD defined by the investigator.
  • If the patient is taking background corticosteroids, dose must be ≤ 10 mg/day prednisone (or equivalent) and must have been at a stable dose for at least 4 weeks prior to screening.
  • Use of nonsteroidal anti-inflammatory drugs (NSAIDs) for the treatment of psoriasis arthritis is permitted if the dose has been stable for at least 2 weeks prior to screening.
  • If the patient is taking methotrexate (MTX), the patient must have received methotrexate 7.5-25 mg/wk (p.o. or parenteral) for at least 12 weeks and at a stable dose for 4 weeks prior to screening. If the patient is not taking MTX, they must have been off the drug for at least 8 weeks prior to receiving the first dose (baseline).
  • Folic acid or folinic acid is required at least 1 mg per day or 5 mg per week for all patients taking MTX.
  • Whether or not the patient is taking methotrexate, all DMARDs (other than MTX) should be withdrawn at least 4 weeks prior to baseline (Visit 2) of first drug administration (4 weeks for etanercept, 8 weeks for infliximab, adalimumab, golimumab, certolizumab pegol and leflunomide, and 12 weeks for ustekinumab, c.f. Section 4.2.2). Subjects taking appremilast should discontinue the medication 2 weeks prior to receiving the first dose (baseline).
  • Females of childbearing potential must have a negative pregnancy test result prior to enrolment. Male and female of childbearing potential must agree to use a highly effective method of birth control during the study.
  • A female is considered of childbearing potential following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilization methods include hysterectomy, bilateral salpingectomy, bilateral tubal ligation and bilateral oophorectomy. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a post-menopausal state in women not using hormonal contraception or hormonal replacement therapy. However in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient.
  • A man is considered fertile after puberty unless permanently sterile by bilateral orchidectomy.
  • 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

  • History of malignancy in the past 5 years or suspicion of active malignant disease.
  • Evidence of current or previous clinically significant disease, medical condition other than psoriatic arthritis, 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.
  • Presence of another rheumatic or skin disease that, in the opinion of the investigator, could confound the ability to discern response.
  • HIV infection or a known HIV-related Malignancy.
  • Chronic or acute hepatitis B and C, or carrier status.
  • History of recurrent significant infection; known active bacterial, viral, fungal, mycobacterial infection, or any major episode of infection requiring hospitalization or treatment with iv antibiotics within 4 weeks of screening or oral antibiotics within 2 weeks prior to screening.
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  • Tuberculosis or a positive Quantiferon test for tuberculosis.
  • History of allergy/hypersensitivity to a systemically administered biologic agent or its excipients.
  • Intake of restricted medications (c.f. Section 4.2.2) or other drugs considered likely to interfere with the safe conduct of the study.
  • Previous treatment with any cell-depleting therapies, including investigational agents (e.g., CAMPATH, anti-CD4, anti-CD5, anti-CD3). Patients with Orencia or Toclizumab treatment within 8 weeks, IVIG, Natalizumab or Prosorba Column treatment within 6 months, and anti-CD19 or anti-CD20 treatment within 1 year should be excluded.
  • Immunization with a vaccine within 4 weeks prior to baseline (Visit 2) of the first drug administration (e.g.; MMR, Varivax).
  • 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 (Section 4.2.2 of the protocol) can be enrolled.
  • Patients with any of the following laboratory values at screening and are considered clinically significant by the investigators:
  • Haemoglobin < 9 g/dL, hematocrit, white blood cell count, absolute lymphocyte or platelet count < LLN (below the lower limit of the reference normal range), or absolute neutrophil < 1500/µL
  • ALT, AST and/or total bilirubin > 2 x ULN
  • Serum creatinine > 1.5 x 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

7 sites in 1 country.

7 sites in 1 country

United States7 sites

  • Northwestern University

    Chicago, Illinois, 60611

  • Metroplex Clinical Research Center, LLC

    Dallas, Texas, 75231

  • UC San Diego

    La Jolla, California, 92037

  • Justus J. Fiechtner, MD, PC

    Lansing, Michigan, 48910

  • Stanford University

    Palo Alto, California, 94304

  • Sarasota Arthritis Research Center

    Sarasota, Florida, 34239

  • Seattle Rheumatology Associates/Swedish Clinical Research

    Seattle, Washington, 98122

Other trials in United States

About this study

Official title: Efficacy and Safety of AbGn-168H in Patients With Active Psoriatic Arthritis: a 24-week, Open-label, Multi-center, Phase II Proof of Principle Trial.

To evaluate efficacy, safety, tolerability, and immunogenicity of AbGn-168H administered intravenously in patients with active psoriatic arthritis.

Read the detailed description

This is an open-label, multi-center, multi-dose phase II proof of principle trial to study the efficacy and safety of AbGn-168H in patients with moderate to severe active psoriatic arthritis. A minimum of 15 patients and a maximum of 20 will be recruited in 1 dosing group. For safety evaluation, the parameters to be assessed include physical examination, vital signs (blood pressure, heart rate, respiratory rate and body temperature), 12-lead ECG, safety laboratory tests, adverse events and tolerability. For efficacy evaluation, patients will be evaluated for proportion of subject reaching American College of Rheumatology 20 (ACR 20) in week 12 and proportion of subjects reaching ACR 20, ACR 50 and ACR 70 at different time points; Disease Activity Score 28 (DAS28) at different time points, as well as Target Lesion Psoriasis Severity Score (TLPSS) and static Physician Global Assessment (sPGA) for subjects with active skin lesions at different time point.

Being tested
AbGn-168H
Medical subject headings
Arthritis, Psoriatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AbGn-168HBiological

    monoclonal antibody

Study groups in NCT02267642
Study groupRoleWhat they receive
AbGn-168HExperimentalSeven (7) intravenous doses of AbGn-168H on D1 (Week 0), Day 8 (Week 1), Day 15 (Week 2), Day D29 (Week 4), D43 (Week 6), Day 57 (Week 8) and Day 71 (Week 10)
Receives: Biological: AbGn-168H

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of subject reaching American College of Rheumatology score 20 (ACR20)

    Measured: at 12-week after the first treatment

Secondary outcomes (7)

  1. Proportion of subjects reaching American College of Rheumatology score 20, 50 and 70 (ACR 20, ACR 50 and ACR70)

    Measured: up to 24 weeks after the first treatment

  2. Disease Activity Score 28 (DAR28)

    Measured: up 24 weeks after the first treatment

  3. Target Lesion Psoriasis Severity Score (TLPSS) for subjects with active skin lesions

    Measured: up 24 weeks after the first treatment

  4. static Physician's Global Assessment (sPGA) for subjects with active skin lesions

    Measured: up to 24 weeks after the first treatment

  5. Number of subjects with Adverse Event

    Measured: up to 24 weeks after the first treatment

  6. Immunogenicity

    Measured: up to 24 weeks after the first treatment

  7. Number of subject with abnormal clinical laboratory parameters

    Measured: up to 24 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.

  1. First posted17 Oct 2014 (estimated)
  2. Study startJan 2015
  3. Primary completionOct 2015
  4. Study completionJan 2016

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02267642
Sponsor's protocol ID
2014.009.01
Status last verified
Jan 2017
First submitted
10 Oct 2014
Last updated
24 Jan 2017
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing AbGn-168H in people with Psoriatic Arthritis, run by AbGenomics B.V Taiwan Branch at 7 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 16 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 24 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 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. 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?

Proportion of subject reaching American College of Rheumatology score 20 (ACR20) (time frame: at 12-week after the first treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02267642.

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 24 Jan 2017.

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