Ankylosing SpondylitisPhase 2NCT04795141
ABY-035 in the Treatment of Subjects With Ankylosing Spondylitis
A Phase 2 study testing ABY-035 in people with Ankylosing Spondylitis, run by Inmagene LLC at 47 sites in 3 countries.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ankylosing Spondylitis
- What is being tested?
- ABY-035
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 47 sitesin 3 countries
- Study dates
- 24 Aug 2021to 30 Aug 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)..
Who cannot join
- 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
Show all 14Show fewer
- 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.
Trial locations and contacts
47 sites in 3 countries.
47 sites in 3 countries
China25 sites
The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and TechNology
Baotou, Inner Mongolia
Beijing Chao-Yang Hospital,Capital Medical University
Beijing, Beijing Municipality
The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui
The First Hospital of Jilin University
Changchun, Jilin
West China Hospital of Sichuan University
Chengdu, Sichuan
Kaohsiung Chang Gung Memorial Hospital ，Chang Gung Medical Foundation
Gaoxiong, Taiwan
Kaohsiung Veterans General Hospital
Gaoxiong, Taiwan
Sun Yat-Sen Memorial Hospital Sun Yat-Sen University
Guangzhou, Guangdong
Anhui Provincial Hospital
Hefei, Anhui
The Affiliated Hospital of The Affiliated Hospital of Inner Mongolia Medical University Medical University
Hohhot, The Affiliated Hospital of Inner Mongolia Medical University
Linyi People's Hospital
Linyi, Shandong
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi
The Affiliated Drum Tower Hospital of Nanjing University Medical School
Nanjing, Jiangsu
Changhai Hospital of Shanghai
Shanghai, Shanghai Municipality
Shanghai Changzheng Hospital
Shanghai, Shanghai Municipality
Shenzhen People's Hospital
Shenzhen, Guangdong
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu
National Taiwan University Hospital (NTUH)
Taibei, Taiwan
Tri-Service General Hospital
Taibei, Taiwan
China Medical University Hospital (CMUH)
Taizhong, Taiwan
Chung Shan Medical University Hospital (CSMHU)
Taizhong, Taiwan
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality
Tong Ji Hospital TongJi Medical Colleague of HUST
Wuhan, Hubei
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan
Zhuzhou Hospital Affiliated to Xiangya School of Medicine
Zhuzhou, Hunan
United States15 sites
Arthritis and Rheumatic Disease Specialties
Aventura, Florida, 33180
Hope Clinical Research
Canoga Park, California, 91303
HRMD Research
Dallas, Texas, 75240
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635
M3 Emerging Medical Research, LLC
Durham, North Carolina, 27704
Arizona Arthritis & Rheumatology Research, PLLC
Glendale, Arizona, 85306
Klein & Associates, M.D., P.A.
Hagerstown, Maryland, 21740
Newport Huntington Medical Group
Huntington Beach, California, 92648
Desert Medical Advances
Palm Desert, California, 92260
Clinical Research Source, Inc.
Perrysburg, Ohio, 43551
Drucker Sarasota Arthritis Research Center
Sarasota, Florida, 34293
Greater Chicago Specialty Physicians/ Clinical Investigation Specialists, Inc.
Schaumburg, Illinois, 60195
Seattle Rheumatology Associates
Seattle, Washington, 98122
Clinic of Robert Hozman, MD / Clinical Investigation Specialists,
Skokie, Illinois, 60076
The Center for Rheumatology and Bone Research
Wheaton, Maryland, 20902
South Korea7 sites
Chonnam National University Hospital
Gwangju, Gwangju
Ajou University Hospital
Gyeonggi-do
Bundang Seoul National University Hospital
Gyeonggi-do
Inha University Hospital
Incheon
Hanyang University Seoul Hospital
Seoul
Kyunghee University Hospital
Seoul
SNU Boramae Medical Center
Seoul
About this study
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
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.
Read the 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.
- Conditions
- Ankylosing Spondylitis
- Being tested
- ABY-035, Placebo
- Medical subject headings
- Spondylitis, Ankylosing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABY-035Drug
Also called Izokibep
ABY-035 Solution for injection
PlaceboDrug
Also called Normal Saline
Normal Saline for injection
| Study group | Role | What they receive |
|---|---|---|
| #1: Cohort 1-High Dose Q2W | Experimental | Cohort 1: ABY-035 High Dose, every 2 weeks, subcutaneous injection Receives: Drug: ABY-035 |
| #2: Cohort 1-High Dose Q4W | Experimental | Cohort 1: ABY-035 High Dose, every 4 weeks, subcutaneous injection Receives: Drug: ABY-035 |
| #3: Cohort 1-Low Dose Q2W | Experimental | Cohort 1: ABY-035 Low Dose, every 2 weeks, subcutaneous injection Receives: Drug: ABY-035 |
| #4: Cohort 2-Low Dose QW | Experimental | Cohort 2: ABY-035 Low Dose, every week, subcutaneous injection Receives: Drug: ABY-035 |
| #5: Cohort 2-High Dose QW | Experimental | Cohort 2: ABY-035 High Dose, every week, subcutaneous injection Receives: Drug: ABY-035 |
| #1: Cohort 1-Placebo Q2W | Placebo comparator | Cohort 1: Placebo, every 2 weeks, subcutaneous injection Receives: Drug: Placebo |
| #2: Cohort 2-Placebo QW | Placebo comparator | Cohort 2: Placebo, every week, subcutaneous injection Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects achieving an ASAS40 response
The treatment effect
Measured: 16 weeks
Secondary outcomes (13)
Change from baseline in BASDAI
The treatment effect
Measured: 16 weeks
Change from baseline in BASFI
The treatment effect
Measured: 16 weeks
Proportion of subjects reaching ASDAS-MI
The treatment effect
Measured: 16 weeks
Incidence of AEs
Safety information
Measured: 74 weeks
Incidence of serious adverse events (SAEs) and adverse events of special interests (AESIs)
Safety information
Measured: 74 weeks
AEs leading to withdrawal from investigational medicinal product (IMP)
Safety information
Measured: 74 weeks
Change in safety laboratory parameters and vital signs compared to baseline
Safety information
Measured: 74 weeks
Proportion of subjects achieving an ASAS40 response, ASAS20 response, ASAS partial remission, and ASAS 5/6 response respectively at required timepoints
The treatment effect
Measured: 52 weeks
Change from baseline in BASDAI and BASFI at required timepoints
The treatment effect
Measured: 52 weeks
Proportion of subjects reaching BASDAI50 and ASDAS-MI at required timepoints
The treatment effect
Measured: 52 weeks
Proportion of subjects experiencing clinically important improvement at required timepoints
The treatment effect
Measured: 52 weeks
ASDAS-CRP and ASDAS status at required timepoints
The treatment effect
Measured: 52 weeks
Change from baseline in total and nocturnal pain at required timepoints
The treatment effect
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2021
- Study start24 Aug 2021
- Primary completion11 Jul 2022
- Study completion30 Aug 2022
Why it stopped: The sponsor's development strategy is adjusted.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankylosing SpondylitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inmagene LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Affibody
- Responsible party
- Sponsor
- Investigators
- Lawrence He, Study director, SVP, Global Regulatory Head
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04795141
- Sponsor's protocol ID
- ABY-035-204
- Status last verified
- Jul 2023
- First submitted
- 3 Mar 2021
- Last updated
- 12 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04795141
- Acronym / sponsor ID
- ABY-035-204
- Conditions
- Ankylosing Spondylitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The sponsor's development strategy is adjusted.
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Inmagene LLCIndustry (pharma, biotech, devices)
- Collaborators
- Affibody
- Study start
- 24 Aug 2021 (actual)
- Primary completion
- 11 Jul 2022 (actual)
- Study completion
- 30 Aug 2022 (actual)
- First posted
- 12 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| #1: Cohort 1-High Dose Q2W | Experimental | Drug: ABY-035Cohort 1: ABY-035 High Dose, every 2 weeks, subcutaneous injection |
| #2: Cohort 1-High Dose Q4W | Experimental | Drug: ABY-035Cohort 1: ABY-035 High Dose, every 4 weeks, subcutaneous injection |
| #3: Cohort 1-Low Dose Q2W | Experimental | Drug: ABY-035Cohort 1: ABY-035 Low Dose, every 2 weeks, subcutaneous injection |
| #4: Cohort 2-Low Dose QW | Experimental | Drug: ABY-035Cohort 2: ABY-035 Low Dose, every week, subcutaneous injection |
| #5: Cohort 2-High Dose QW | Experimental | Drug: ABY-035Cohort 2: ABY-035 High Dose, every week, subcutaneous injection |
| #1: Cohort 1-Placebo Q2W | Placebo comparator | Drug: PlaceboCohort 1: Placebo, every 2 weeks, subcutaneous injection |
| #2: Cohort 2-Placebo QW | Placebo comparator | Drug: PlaceboCohort 2: Placebo, every week, subcutaneous injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (14 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ABY-035Also: IzokibepABY-035 Solution for injection | Drug | #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 |
| PlaceboAlso: Normal SalineNormal Saline for injection | Drug | #1: Cohort 1-Placebo Q2W, #2: Cohort 2-Placebo QW |
Primary outcome
Proportion of subjects achieving an ASAS40 response
Time frame: 16 weeks
The treatment effect
13 secondary outcomes
Change from baseline in BASDAI
Time frame: 16 weeks
Change from baseline in BASFI
Time frame: 16 weeks
Proportion of subjects reaching ASDAS-MI
Time frame: 16 weeks
Incidence of AEs
Time frame: 74 weeks
Incidence of serious adverse events (SAEs) and adverse events of special interests (AESIs)
Time frame: 74 weeks
AEs leading to withdrawal from investigational medicinal product (IMP)
Time frame: 74 weeks
Change in safety laboratory parameters and vital signs compared to baseline
Time frame: 74 weeks
Proportion of subjects achieving an ASAS40 response, ASAS20 response, ASAS partial remission, and ASAS 5/6 response respectively at required timepoints
Time frame: 52 weeks
Change from baseline in BASDAI and BASFI at required timepoints
Time frame: 52 weeks
Proportion of subjects reaching BASDAI50 and ASDAS-MI at required timepoints
Time frame: 52 weeks
Proportion of subjects experiencing clinically important improvement at required timepoints
Time frame: 52 weeks
ASDAS-CRP and ASDAS status at required timepoints
Time frame: 52 weeks
Change from baseline in total and nocturnal pain at required timepoints
Time frame: 52 weeks
Results and safety
The study was stopped early (reason given: The sponsor's development strategy is adjusted.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lawrence He study director
SVP, Global Regulatory Head
47 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ABY-035 in people with Ankylosing Spondylitis, run by Inmagene LLC at 47 sites in 3 countries.
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 6 inclusion and 14 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: stopped early, as of the sponsor's last update on 12 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 47 sites in China, United States, South Korea. 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. Some participants in this study may receive a placebo. 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 was stopped early (reason given: The sponsor's development strategy is adjusted.). Results are not available in the source record.
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 subjects achieving an ASAS40 response (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Jul 2023; AzTrials last refreshed its copy on 8 Nov 2026.