Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02267642
Other study ID # 2014.009.01
Secondary ID
Status Completed
Phase Phase 2
First received October 10, 2014
Last updated January 23, 2017
Start date January 2015
Est. completion date January 2016

Study information

Verified date January 2017
Source AbGenomics B.V Taiwan Branch
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date January 2016
Est. primary completion date October 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion criteria

1. Patient must give informed consent and sign an approved consent form prior to any study procedures

2. Age 18 to 75 (inclusive), males or females

3. Body weight < 140 kg

4. Subject has had a diagnosis of psoriatic arthritis for at least 6 months and currently meets the CASPAR criteria.

5. 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.

6. 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.

7. Patients must have history of inadequate response or intolerance to NSAID or DMARD defined by the investigator.

8. 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.

9. 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.

10. 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).

11. Folic acid or folinic acid is required at least 1 mg per day or 5 mg per week for all patients taking MTX.

12. 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).

13. 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).

Exclusion criteria

1. History of malignancy in the past 5 years or suspicion of active malignant disease.

2. 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.

3. Presence of another rheumatic or skin disease that, in the opinion of the investigator, could confound the ability to discern response.

4. HIV infection or a known HIV-related Malignancy.

5. Chronic or acute hepatitis B and C, or carrier status.

6. 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.

7. Tuberculosis or a positive Quantiferon test for tuberculosis.

8. History of allergy/hypersensitivity to a systemically administered biologic agent or its excipients.

9. Intake of restricted medications (c.f. Section 4.2.2) or other drugs considered likely to interfere with the safe conduct of the study.

10. 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.

11. Immunization with a vaccine within 4 weeks prior to baseline (Visit 2) of the first drug administration (e.g.; MMR, Varivax).

12. Current alcohol abuse.

13. 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.

14. 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

15. Any clinically significant laboratory abnormalities other than those listed on Exclusion Criteria 14, based on the investigator's medical assessment at screening

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
AbGn-168H
monoclonal antibody

Locations

Country Name City State
United States Northwestern University Chicago Illinois
United States Metroplex Clinical Research Center, LLC Dallas Texas
United States UC San Diego La Jolla California
United States Justus J. Fiechtner, MD, PC Lansing Michigan
United States Stanford University Palo Alto California
United States Sarasota Arthritis Research Center Sarasota Florida
United States Seattle Rheumatology Associates/Swedish Clinical Research Seattle Washington

Sponsors (1)

Lead Sponsor Collaborator
AbGenomics B.V Taiwan Branch

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Proportion of subject reaching American College of Rheumatology score 20 (ACR20) at 12-week after the first treatment
Secondary Proportion of subjects reaching American College of Rheumatology score 20, 50 and 70 (ACR 20, ACR 50 and ACR70) up to 24 weeks after the first treatment
Secondary Disease Activity Score 28 (DAR28) up 24 weeks after the first treatment
Secondary Target Lesion Psoriasis Severity Score (TLPSS) for subjects with active skin lesions up 24 weeks after the first treatment
Secondary static Physician's Global Assessment (sPGA) for subjects with active skin lesions up to 24 weeks after the first treatment
Secondary Number of subjects with Adverse Event up to 24 weeks after the first treatment
Secondary Immunogenicity up to 24 weeks after the first treatment
Secondary Number of subject with abnormal clinical laboratory parameters up to 24 weeks after the first treatment
See also
  Status Clinical Trial Phase
Completed NCT04152759 - Comparative Study to Evaluate the Pharmacokinetics of BAT2506 vs Simponi® in Healthy Subjects Phase 1
Completed NCT03248518 - Lessening the Impact of Fatigue in Inflammatory Rheumatic Diseases N/A
Completed NCT01925768 - Safety and Efficacy Study of Apremilast to Treat Psoriatic Arthritis Phase 3
Completed NCT01892436 - Extension Study up to 3 Years for Secukinumab in Psoriatic Arthritis Phase 3
Completed NCT01212770 - PALACE 3: Efficacy and Safety Study of Apremilast to Treat Active Psoriatic Arthritis Phase 3
Completed NCT05051943 - A Study of the Real-world Use of an Adalimumab Biosimilar and Evaluation of Nutritional Status on the Therapeutic Response
Completed NCT01212757 - PALACE 2: Efficacy and Safety Study of Apremilast to Treat Active Psoriatic Arthritis Phase 3
Completed NCT03953378 - CD73+ Th1.17 in Rheumatoid Arthritis and Psoriatic Arthritis
Recruiting NCT02572700 - Pain Mechanisms and Ultrasonographic Disease Activity in Psoriatic Arthritis
Completed NCT02556034 - Assessment of Tender & Swollen Joints Count Score Performed by a Rheumatologist And Rheumatology Nurses in Patients With RA and PsA.
Completed NCT02154425 - A Multicenter, Postmarketing Study Evaluating the Concentration of Cimzia® in Mature Breast Milk of Lactating Mothers Phase 1
Completed NCT02188654 - Metformin in Psoriatic Arthritis N/A
Completed NCT01392326 - Efficacy at 24 Weeks and Long Term Safety, Tolerability and Efficacy up to 2 Years of Secukinumab (AIN457) in Patients With Active Psoriatic Arthritis (PsA) Phase 3
Completed NCT02164214 - Does Etanercept Influence Tweak Modulation of Inflammation During Inflammatory Rheumatisms (Psoriatic Arthritis and Rheumatoid Arthritis)? Phase 3
Completed NCT01083693 - Quality of Life Outcomes of HUMIRA in Rheumatoid Arthritis (RA), Psoriatic Arthritis (PsA), Ankylosing Spondylitis (AS) After Unsustainable Response to Biologicals and Disease Modifying Antirheumatic Drugs N/A
Not yet recruiting NCT00517101 - Presence of IBD Specific Antibodies (ASCA, ALCA, ACCA, AMCA) in the Sera of Patients With Spondyloarthropathy N/A
Completed NCT00133315 - TNFalfa Blocking Treatment of Spondylarthropathies Phase 4
Completed NCT00659412 - A Placebo-controlled Study With an Extension Examining the Safety and Efficacy of Alefacept in Psoriatic Arthritis Phase 2
Completed NCT00946686 - To Demonstrate the Relative Bioavailability, Parallel Study Of Leflunomide 20 mg Tablets Under Fasting Conditions Phase 1
Not yet recruiting NCT06059430 - Cohort Project of Patients With Inflammatory Rheumatism