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

Phase 2

Completed

• Conditions: Psoriatic Arthritis
• Interventions: Biological: AbGn-168H

• Registration Number: NCT02267642
• Lead Sponsor: AbGenomics B.V Taiwan Branch

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2014-10-10
• Study First Submitted QC: 2014-10-15
• Study First Posted: 2014-10-17
• Study Start: 2015-01
• Primary Completion: 2015-10
• Study Completion: 2016-01
• Status Verified: 2017-01
• Disposition First Submitted: 2017-01-23
• Disposition First Submitted QC: 2017-01-23
• Last Update Submitted: 2017-01-23
• Disposition First Posted: 2017-01-24
• Last Update Posted: 2017-01-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
AbGn-168H	AbGn-168H	Seven (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)

Primary Outcome Measures

Name	Time	Method
Proportion of subject reaching American College of Rheumatology score 20 (ACR20)	at 12-week after the first treatment

Secondary Outcome Measures

Name	Time	Method
Disease Activity Score 28 (DAR28)	up 24 weeks after the first treatment
Number of subjects with Adverse Event	up to 24 weeks after the first treatment
Immunogenicity	up to 24 weeks after the first treatment
Target Lesion Psoriasis Severity Score (TLPSS) for subjects with active skin lesions	up 24 weeks after the first treatment
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
static Physician's Global Assessment (sPGA) for subjects with active skin lesions	up to 24 weeks after the first treatment
Number of subject with abnormal clinical laboratory parameters	up to 24 weeks after the first treatment

Trial Locations

Locations (7)

UC San Diego; 🇺🇸 La Jolla, California, United States

Northwestern University; 🇺🇸 Chicago, Illinois, United States

Justus J. Fiechtner, MD, PC; 🇺🇸 Lansing, Michigan, United States

Seattle Rheumatology Associates/Swedish Clinical Research; 🇺🇸 Seattle, Washington, United States

Stanford University; 🇺🇸 Palo Alto, California, United States

Metroplex Clinical Research Center, LLC; 🇺🇸 Dallas, Texas, United States

Sarasota Arthritis Research Center; 🇺🇸 Sarasota, Florida, United States