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ABY-035 in the Treatment of Subjects With Ankylosing Spondylitis

Primary Purpose

Ankylosing Spondylitis

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
ABY-035
Placebo
Sponsored by
Inmagene LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ankylosing Spondylitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Male or female at least 18 years of age.

  2. Subjects with active AS, determined by documented radiologic evidence (X-ray) fulfilling the Modified New York criteria for AS (1984).

    AND At least one SpA feature, according to ASAS criteria.

  3. Subjects have moderate to severe active disease
  4. Subjects must have inadequate response or intolerance to at least 2 NSAIDs, or contraindication to NSAID therapy.
  5. Subjects may be TNFα inhibitor-naïve or may have received up to 2 prior TNFα inhibitor(s)..

Exclusion Criteria:

  1. Subjects have active fibromyalgia or total spinal ankylosis ('bamboo spine'), or any other inflammatory arthritis.
  2. Subjects have used medications in the manner as detailed by the exclusion criteria as detailed in the study protocol.
  3. Subjects have received technetium-99 conjugated with methylene diphosphonate other than for diagnostic purpose within 5 years prior to baseline.
  4. Have received any live (includes attenuated) vaccination within the 12 weeks prior to the baseline.
  5. Subjects have received any non-biological therapy for AS not listed as detailed in the study protocol within or outside a clinical study in the 3 months or within 5 half-lives prior to the Baseline Visit (whichever is longer).
  6. Subject has an active infection or history of infections
  7. Have evidence of or test positive for hepatitis B virus (HBV)
  8. Have evidence of or test positive for hepatitis C virus (HCV).
  9. Have a historically positive human immunodeficiency virus (HIV) test or test positive at screening for HIV.
  10. Subjects have known tuberculosis (TB) infection, at high risk of acquiring TB infection, or current or history of nontuberculous mycobacterium (NTMB) infection, or LTB.
  11. Have a history of a lymphoproliferative disorder including lymphoma or current signs and symptoms suggestive of lymphoproliferative disease.
  12. Subjects have active Crohn's disease (CD) or active ulcerative colitis (UC).
  13. Subjects have active uveitis within 6 weeks prior to baseline.
  14. Subjects have laboratory abnormalities at Screening.

Sites / Locations

  • Arizona Arthritis & Rheumatology Research, PLLC
  • Hope Clinical Research
  • Newport Huntington Medical Group
  • Desert Medical Advances
  • Arthritis and Rheumatic Disease Specialties
  • Drucker Sarasota Arthritis Research Center
  • Greater Chicago Specialty Physicians/ Clinical Investigation Specialists, Inc.
  • Clinic of Robert Hozman, MD / Clinical Investigation Specialists,
  • Klein & Associates, M.D., P.A.
  • The Center for Rheumatology and Bone Research
  • M3 Emerging Medical Research, LLC
  • Clinical Research Source, Inc.
  • Altoona Center for Clinical Research
  • HRMD Research
  • Seattle Rheumatology Associates
  • The First Affiliated Hospital of Bengbu Medical College
  • Anhui Provincial Hospital
  • Beijing Chao-Yang Hospital,Capital Medical University
  • Sun Yat-Sen Memorial Hospital Sun Yat-Sen University
  • Shenzhen People's Hospital
  • The First Affiliated Hospital of Zhengzhou University
  • Tong Ji Hospital TongJi Medical Colleague of HUST
  • Zhuzhou Hospital Affiliated to Xiangya School of Medicine
  • The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and TechNology
  • The Affiliated Drum Tower Hospital of Nanjing University Medical School
  • The First Affiliated Hospital of Soochow University
  • The First Affiliated Hospital of Nanchang University
  • The First Hospital of Jilin University
  • Linyi People's Hospital
  • Changhai Hospital of Shanghai
  • Shanghai Changzheng Hospital
  • West China Hospital of Sichuan University
  • Kaohsiung Chang Gung Memorial Hospital ，Chang Gung Medical Foundation
  • Kaohsiung Veterans General Hospital
  • National Taiwan University Hospital (NTUH)
  • Tri-Service General Hospital
  • China Medical University Hospital (CMUH)
  • Chung Shan Medical University Hospital (CSMHU)
  • The Affiliated Hospital of The Affiliated Hospital of Inner Mongolia Medical University Medical University
  • Tianjin Medical University General Hospital
  • Chonnam National University Hospital
  • Ajou University Hospital
  • Bundang Seoul National University Hospital
  • Inha University Hospital
  • Hanyang University Seoul Hospital
  • Kyunghee University Hospital
  • SNU Boramae Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Placebo Comparator

Placebo Comparator

Arm Label

#1: Cohort 1-High Dose Q2W

#2: Cohort 1-High Dose Q4W

#3: Cohort 1-Low Dose Q2W

#4: Cohort 2-Low Dose QW

#5: Cohort 2-High Dose QW

#1: Cohort 1-Placebo Q2W

#2: Cohort 2-Placebo QW

Arm Description

Cohort 1: ABY-035 High Dose, every 2 weeks, subcutaneous injection

Cohort 1: ABY-035 High Dose, every 4 weeks, subcutaneous injection

Cohort 1: ABY-035 Low Dose, every 2 weeks, subcutaneous injection

Cohort 2: ABY-035 Low Dose, every week, subcutaneous injection

Cohort 2: ABY-035 High Dose, every week, subcutaneous injection

Cohort 1: Placebo, every 2 weeks, subcutaneous injection

Cohort 2: Placebo, every week, subcutaneous injection

Outcomes

Primary Outcome Measures

Proportion of subjects achieving an ASAS40 response
The treatment effect

Secondary Outcome Measures

Change from baseline in BASDAI
The treatment effect
Change from baseline in BASFI
The treatment effect
Proportion of subjects reaching ASDAS-MI
The treatment effect
Incidence of AEs
Safety information
Incidence of serious adverse events (SAEs) and adverse events of special interests (AESIs)
Safety information
AEs leading to withdrawal from investigational medicinal product (IMP)
Safety information
Change in safety laboratory parameters and vital signs compared to baseline
Safety information
Proportion of subjects achieving an ASAS40 response, ASAS20 response, ASAS partial remission, and ASAS 5/6 response respectively at required timepoints
The treatment effect
Change from baseline in BASDAI and BASFI at required timepoints
The treatment effect
Proportion of subjects reaching BASDAI50 and ASDAS-MI at required timepoints
The treatment effect
Proportion of subjects experiencing clinically important improvement at required timepoints
The treatment effect
ASDAS-CRP and ASDAS status at required timepoints
The treatment effect
Change from baseline in total and nocturnal pain at required timepoints
The treatment effect

Full Information

First Posted
March 3, 2021
Last Updated
July 6, 2023
Sponsor
Inmagene LLC
Collaborators
Affibody
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1. Study Identification

Unique Protocol Identification Number
NCT04795141
Brief Title
ABY-035 in the Treatment of Subjects With Ankylosing Spondylitis
Official Title
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety and Tolerability of ABY-035 in the Treatment of Subjects With Ankylosing Spondylitis
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Terminated
Why Stopped
The sponsor's development strategy is adjusted.
Study Start Date
August 24, 2021 (Actual)
Primary Completion Date
July 11, 2022 (Actual)
Study Completion Date
August 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Inmagene LLC
Collaborators
Affibody

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
ABY-035-204 is a clinical study to assess the efficacy of IL-17 blocker ABY-035 in ankylosing spondylitis(AS). The primary objective is to estimate the relationship between different dose regimens of ABY-035 and clinical response as assessed by Assessment of Spondyloarthritis International Society 40 (ASAS40) response at Week 16 in subjects with active AS.
Detailed Description
ABY-035-204 is a double-blind, randomized, parallel-group, placebo-controlled study. The primary objective is to estimate the relationship between different dose regimens of ABY-035 and clinical response as assessed by Assessment of Spondyloarthritis International Society 40 (ASAS40) response at Week 16 in subjects with active AS. The study will include the following 3 periods: Screening Period: Up to 35 days prior to baseline randomization. Treatment Period 1: Day 0-Week 16 Cohort 1: Eligible subjects will be randomized 1:1:1:1 to receive 1 of 4 treatments (ABY-035 High Dose every 2 weeks (Q2W), ABY-035 Low Dose every 2 weeks (Q2W), ABY-035 High Dose every 4 weeks (Q4W), or placebo Q2W), and will remain on their allowable background medication. Cohort 2: Eligible subjects will be randomized 1:1:1 to receive 1 of 3 treatments (ABY-035 High Dose every week (QW), ABY-035 Low Dose every week (QW), or placebo QW), and will remain on their allowable background medication. Randomization will be stratified by region (North Eastern Asia and North America) and previous tumor necrosis factor alpha (TNFα) inhibitor exposure (TNFα inhibitor treated or TNFα inhibitor naïve). Maximum 30% of subjects will be TNFα inhibitor-treated subjects to ensure a representative population for the assessment of efficacy and safety. Treatment Period 1 ends at Week 16 after all trial assessments have been done and Treatment Period 2 starts at Week 16 with the IMP injection. Treatment Period 2 (Extension Period): Week 16-Week 52 Cohort 1: Subjects will receive ABY-035 High Dose Q2W treatment in an open-label manner. Cohort 2: Subjects will receive ABY-035 High Dose QW treatment in an open-label manner. At Week24, subjects who could not achieve an ASAS20 response from baseline are defined as non-responders and will discontinue the study treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ankylosing Spondylitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
#1: Cohort 1-High Dose Q2W
Arm Type
Experimental
Arm Description
Cohort 1: ABY-035 High Dose, every 2 weeks, subcutaneous injection
Arm Title
#2: Cohort 1-High Dose Q4W
Arm Type
Experimental
Arm Description
Cohort 1: ABY-035 High Dose, every 4 weeks, subcutaneous injection
Arm Title
#3: Cohort 1-Low Dose Q2W
Arm Type
Experimental
Arm Description
Cohort 1: ABY-035 Low Dose, every 2 weeks, subcutaneous injection
Arm Title
#4: Cohort 2-Low Dose QW
Arm Type
Experimental
Arm Description
Cohort 2: ABY-035 Low Dose, every week, subcutaneous injection
Arm Title
#5: Cohort 2-High Dose QW
Arm Type
Experimental
Arm Description
Cohort 2: ABY-035 High Dose, every week, subcutaneous injection
Arm Title
#1: Cohort 1-Placebo Q2W
Arm Type
Placebo Comparator
Arm Description
Cohort 1: Placebo, every 2 weeks, subcutaneous injection
Arm Title
#2: Cohort 2-Placebo QW
Arm Type
Placebo Comparator
Arm Description
Cohort 2: Placebo, every week, subcutaneous injection
Intervention Type
Drug
Intervention Name(s)
ABY-035
Other Intervention Name(s)
Izokibep
Intervention Description
ABY-035 Solution for injection
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Normal Saline
Intervention Description
Normal Saline for injection
Primary Outcome Measure Information:
Title
Proportion of subjects achieving an ASAS40 response
Description
The treatment effect
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
Change from baseline in BASDAI
Description
The treatment effect
Time Frame
16 weeks
Title
Change from baseline in BASFI
Description
The treatment effect
Time Frame
16 weeks
Title
Proportion of subjects reaching ASDAS-MI
Description
The treatment effect
Time Frame
16 weeks
Title
Incidence of AEs
Description
Safety information
Time Frame
74 weeks
Title
Incidence of serious adverse events (SAEs) and adverse events of special interests (AESIs)
Description
Safety information
Time Frame
74 weeks
Title
AEs leading to withdrawal from investigational medicinal product (IMP)
Description
Safety information
Time Frame
74 weeks
Title
Change in safety laboratory parameters and vital signs compared to baseline
Description
Safety information
Time Frame
74 weeks
Title
Proportion of subjects achieving an ASAS40 response, ASAS20 response, ASAS partial remission, and ASAS 5/6 response respectively at required timepoints
Description
The treatment effect
Time Frame
52 weeks
Title
Change from baseline in BASDAI and BASFI at required timepoints
Description
The treatment effect
Time Frame
52 weeks
Title
Proportion of subjects reaching BASDAI50 and ASDAS-MI at required timepoints
Description
The treatment effect
Time Frame
52 weeks
Title
Proportion of subjects experiencing clinically important improvement at required timepoints
Description
The treatment effect
Time Frame
52 weeks
Title
ASDAS-CRP and ASDAS status at required timepoints
Description
The treatment effect
Time Frame
52 weeks
Title
Change from baseline in total and nocturnal pain at required timepoints
Description
The treatment effect
Time Frame
52 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female at least 18 years of age. Subjects with active AS, determined by documented radiologic evidence (X-ray) fulfilling the Modified New York criteria for AS (1984). AND At least one SpA feature, according to ASAS criteria. Subjects have moderate to severe active disease Subjects must have inadequate response or intolerance to at least 2 NSAIDs, or contraindication to NSAID therapy. Subjects may be TNFα inhibitor-naïve or may have received up to 2 prior TNFα inhibitor(s).. Exclusion Criteria: Subjects have active fibromyalgia or total spinal ankylosis ('bamboo spine'), or any other inflammatory arthritis. Subjects have used medications in the manner as detailed by the exclusion criteria as detailed in the study protocol. Subjects have received technetium-99 conjugated with methylene diphosphonate other than for diagnostic purpose within 5 years prior to baseline. Have received any live (includes attenuated) vaccination within the 12 weeks prior to the baseline. Subjects have received any non-biological therapy for AS not listed as detailed in the study protocol within or outside a clinical study in the 3 months or within 5 half-lives prior to the Baseline Visit (whichever is longer). Subject has an active infection or history of infections Have evidence of or test positive for hepatitis B virus (HBV) Have evidence of or test positive for hepatitis C virus (HCV). Have a historically positive human immunodeficiency virus (HIV) test or test positive at screening for HIV. Subjects have known tuberculosis (TB) infection, at high risk of acquiring TB infection, or current or history of nontuberculous mycobacterium (NTMB) infection, or LTB. Have a history of a lymphoproliferative disorder including lymphoma or current signs and symptoms suggestive of lymphoproliferative disease. Subjects have active Crohn's disease (CD) or active ulcerative colitis (UC). Subjects have active uveitis within 6 weeks prior to baseline. Subjects have laboratory abnormalities at Screening.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lawrence He
Organizational Affiliation
SVP, Global Regulatory Head
Official's Role
Study Director
Facility Information:
Facility Name
Arizona Arthritis & Rheumatology Research, PLLC
City
Glendale
State/Province
Arizona
ZIP/Postal Code
85306
Country
United States
Facility Name
Hope Clinical Research
City
Canoga Park
State/Province
California
ZIP/Postal Code
91303
Country
United States
Facility Name
Newport Huntington Medical Group
City
Huntington Beach
State/Province
California
ZIP/Postal Code
92648
Country
United States
Facility Name
Desert Medical Advances
City
Palm Desert
State/Province
California
ZIP/Postal Code
92260
Country
United States
Facility Name
Arthritis and Rheumatic Disease Specialties
City
Aventura
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
Facility Name
Drucker Sarasota Arthritis Research Center
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34293
Country
United States
Facility Name
Greater Chicago Specialty Physicians/ Clinical Investigation Specialists, Inc.
City
Schaumburg
State/Province
Illinois
ZIP/Postal Code
60195
Country
United States
Facility Name
Clinic of Robert Hozman, MD / Clinical Investigation Specialists,
City
Skokie
State/Province
Illinois
ZIP/Postal Code
60076
Country
United States
Facility Name
Klein & Associates, M.D., P.A.
City
Hagerstown
State/Province
Maryland
ZIP/Postal Code
21740
Country
United States
Facility Name
The Center for Rheumatology and Bone Research
City
Wheaton
State/Province
Maryland
ZIP/Postal Code
20902
Country
United States
Facility Name
M3 Emerging Medical Research, LLC
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27704
Country
United States
Facility Name
Clinical Research Source, Inc.
City
Perrysburg
State/Province
Ohio
ZIP/Postal Code
43551
Country
United States
Facility Name
Altoona Center for Clinical Research
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
Facility Name
HRMD Research
City
Dallas
State/Province
Texas
ZIP/Postal Code
75240
Country
United States
Facility Name
Seattle Rheumatology Associates
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122
Country
United States
Facility Name
The First Affiliated Hospital of Bengbu Medical College
City
Bengbu
State/Province
Anhui
Country
China
Facility Name
Anhui Provincial Hospital
City
Hefei
State/Province
Anhui
Country
China
Facility Name
Beijing Chao-Yang Hospital,Capital Medical University
City
Beijing
State/Province
Beijing
Country
China
Facility Name
Sun Yat-Sen Memorial Hospital Sun Yat-Sen University
City
Guangzhou
State/Province
Guangdong
Country
China
Facility Name
Shenzhen People's Hospital
City
Shenzhen
State/Province
Guangdong
Country
China
Facility Name
The First Affiliated Hospital of Zhengzhou University
City
Zhengzhou
State/Province
Henan
Country
China
Facility Name
Tong Ji Hospital TongJi Medical Colleague of HUST
City
Wuhan
State/Province
Hubei
Country
China
Facility Name
Zhuzhou Hospital Affiliated to Xiangya School of Medicine
City
Zhuzhou
State/Province
Hunan
Country
China
Facility Name
The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and TechNology
City
Baotou
State/Province
Inner Mongolia
Country
China
Facility Name
The Affiliated Drum Tower Hospital of Nanjing University Medical School
City
Nanjing
State/Province
Jiangsu
Country
China
Facility Name
The First Affiliated Hospital of Soochow University
City
Suzhou
State/Province
Jiangsu
Country
China
Facility Name
The First Affiliated Hospital of Nanchang University
City
Nanchang
State/Province
Jiangxi
Country
China
Facility Name
The First Hospital of Jilin University
City
Changchun
State/Province
Jilin
Country
China
Facility Name
Linyi People's Hospital
City
Linyi
State/Province
Shandong
Country
China
Facility Name
Changhai Hospital of Shanghai
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
Shanghai Changzheng Hospital
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
West China Hospital of Sichuan University
City
Chengdu
State/Province
Sichuan
Country
China
Facility Name
Kaohsiung Chang Gung Memorial Hospital ，Chang Gung Medical Foundation
City
Gaoxiong
State/Province
Taiwan
Country
China
Facility Name
Kaohsiung Veterans General Hospital
City
Gaoxiong
State/Province
Taiwan
Country
China
Facility Name
National Taiwan University Hospital (NTUH)
City
Taibei
State/Province
Taiwan
Country
China
Facility Name
Tri-Service General Hospital
City
Taibei
State/Province
Taiwan
Country
China
Facility Name
China Medical University Hospital (CMUH)
City
Taizhong
State/Province
Taiwan
Country
China
Facility Name
Chung Shan Medical University Hospital (CSMHU)
City
Taizhong
State/Province
Taiwan
Country
China
Facility Name
The Affiliated Hospital of The Affiliated Hospital of Inner Mongolia Medical University Medical University
City
Hohhot
State/Province
The Affiliated Hospital Of Inner Mongolia Medical University
Country
China
Facility Name
Tianjin Medical University General Hospital
City
Tianjin
State/Province
Tianjin
Country
China
Facility Name
Chonnam National University Hospital
City
Gwangju,
State/Province
Gwangju
Country
Korea, Republic of
Facility Name
Ajou University Hospital
City
Gyeonggi-do
Country
Korea, Republic of
Facility Name
Bundang Seoul National University Hospital
City
Gyeonggi-do
Country
Korea, Republic of
Facility Name
Inha University Hospital
City
Incheon
Country
Korea, Republic of
Facility Name
Hanyang University Seoul Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Kyunghee University Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
SNU Boramae Medical Center
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

ABY-035 in the Treatment of Subjects With Ankylosing Spondylitis

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