ABY-035 in the Treatment of Subjects With Ankylosing Spondylitis

Ankylosing Spondylitis Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04795141
• Other study ID #: ABY-035-204
• Status: Terminated
• Phase: Phase 2
• Start date: August 24, 2021
• Est. completion date: August 30, 2022

Study information

• Verified date: July 2023
• Source: Inmagene LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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:

1. Screening Period: Up to 35 days prior to baseline randomization.

2. 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.

3. 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 25
• Est. completion date: August 30, 2022
• Est. primary completion date: July 11, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 TNFa inhibitor-naïve or may have received up to 2 prior TNFa 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.

Related Conditions & MeSH terms

• Ankylosing Spondylitis
• Spondylarthritis
• Spondylitis
• Spondylitis, Ankylosing

Intervention

Drug:
• ABY-035
ABY-035 Solution for injection
• Placebo
Normal Saline for injection

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and TechNology	Baotou	Inner Mongolia
China	Beijing Chao-Yang Hospital,Capital Medical University	Beijing	Beijing
China	The First Affiliated Hospital of Bengbu Medical College	Bengbu	Anhui
China	The First Hospital of Jilin University	Changchun	Jilin
China	West China Hospital of Sichuan University	Chengdu	Sichuan
China	Kaohsiung Chang Gung Memorial Hospital ,Chang Gung Medical Foundation	Gaoxiong	Taiwan
China	Kaohsiung Veterans General Hospital	Gaoxiong	Taiwan
China	Sun Yat-Sen Memorial Hospital Sun Yat-Sen University	Guangzhou	Guangdong
China	Anhui Provincial Hospital	Hefei	Anhui
China	The Affiliated Hospital of The Affiliated Hospital of Inner Mongolia Medical University Medical University	Hohhot	The Affiliated Hospital Of Inner Mongolia Medical University
China	Linyi People's Hospital	Linyi	Shandong
China	The First Affiliated Hospital of Nanchang University	Nanchang	Jiangxi
China	The Affiliated Drum Tower Hospital of Nanjing University Medical School	Nanjing	Jiangsu
China	Changhai Hospital of Shanghai	Shanghai	Shanghai
China	Shanghai Changzheng Hospital	Shanghai	Shanghai
China	Shenzhen People's Hospital	Shenzhen	Guangdong
China	The First Affiliated Hospital of Soochow University	Suzhou	Jiangsu
China	National Taiwan University Hospital (NTUH)	Taibei	Taiwan
China	Tri-Service General Hospital	Taibei	Taiwan
China	China Medical University Hospital (CMUH)	Taizhong	Taiwan
China	Chung Shan Medical University Hospital (CSMHU)	Taizhong	Taiwan
China	Tianjin Medical University General Hospital	Tianjin	Tianjin
China	Tong Ji Hospital TongJi Medical Colleague of HUST	Wuhan	Hubei
China	The First Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan
China	Zhuzhou Hospital Affiliated to Xiangya School of Medicine	Zhuzhou	Hunan
Korea, Republic of	Chonnam National University Hospital	Gwangju,	Gwangju
Korea, Republic of	Ajou University Hospital	Gyeonggi-do
Korea, Republic of	Bundang Seoul National University Hospital	Gyeonggi-do
Korea, Republic of	Inha University Hospital	Incheon
Korea, Republic of	Hanyang University Seoul Hospital	Seoul
Korea, Republic of	Kyunghee University Hospital	Seoul
Korea, Republic of	SNU Boramae Medical Center	Seoul
United States	Arthritis and Rheumatic Disease Specialties	Aventura	Florida
United States	Hope Clinical Research	Canoga Park	California
United States	HRMD Research	Dallas	Texas
United States	Altoona Center for Clinical Research	Duncansville	Pennsylvania
United States	M3 Emerging Medical Research, LLC	Durham	North Carolina
United States	Arizona Arthritis & Rheumatology Research, PLLC	Glendale	Arizona
United States	Klein & Associates, M.D., P.A.	Hagerstown	Maryland
United States	Newport Huntington Medical Group	Huntington Beach	California
United States	Desert Medical Advances	Palm Desert	California
United States	Clinical Research Source, Inc.	Perrysburg	Ohio
United States	Drucker Sarasota Arthritis Research Center	Sarasota	Florida
United States	Greater Chicago Specialty Physicians/ Clinical Investigation Specialists, Inc.	Schaumburg	Illinois
United States	Seattle Rheumatology Associates	Seattle	Washington
United States	Clinic of Robert Hozman, MD / Clinical Investigation Specialists,	Skokie	Illinois
United States	The Center for Rheumatology and Bone Research	Wheaton	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Inmagene LLC	Affibody

Countries where clinical trial is conducted

United States,  China,  Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of subjects achieving an ASAS40 response	The treatment effect	16 weeks
Secondary	Change from baseline in BASDAI	The treatment effect	16 weeks
Secondary	Change from baseline in BASFI	The treatment effect	16 weeks
Secondary	Proportion of subjects reaching ASDAS-MI	The treatment effect	16 weeks
Secondary	Incidence of AEs	Safety information	74 weeks
Secondary	Incidence of serious adverse events (SAEs) and adverse events of special interests (AESIs)	Safety information	74 weeks
Secondary	AEs leading to withdrawal from investigational medicinal product (IMP)	Safety information	74 weeks
Secondary	Change in safety laboratory parameters and vital signs compared to baseline	Safety information	74 weeks
Secondary	Proportion of subjects achieving an ASAS40 response, ASAS20 response, ASAS partial remission, and ASAS 5/6 response respectively at required timepoints	The treatment effect	52 weeks
Secondary	Change from baseline in BASDAI and BASFI at required timepoints	The treatment effect	52 weeks
Secondary	Proportion of subjects reaching BASDAI50 and ASDAS-MI at required timepoints	The treatment effect	52 weeks
Secondary	Proportion of subjects experiencing clinically important improvement at required timepoints	The treatment effect	52 weeks
Secondary	ASDAS-CRP and ASDAS status at required timepoints	The treatment effect	52 weeks
Secondary	Change from baseline in total and nocturnal pain at required timepoints	The treatment effect	52 weeks