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ABY-035 in the Treatment of Subjects With Ankylosing Spondylitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04795141
Recruitment Status : Terminated (The sponsor's development strategy is adjusted.)
First Posted : March 12, 2021
Last Update Posted : September 22, 2022
Sponsor:
Collaborator:
Affibody
Information provided by (Responsible Party):
Inmagene Biopharmaceuticals

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.

Condition or disease Intervention/treatment Phase
Ankylosing Spondylitis Drug: ABY-035 Drug: Normal saline Phase 2

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:

  1. Screening Period: Up to 35 days prior to baseline randomization.
  2. Treatment Period 1: Day 0-Week 16 Eligible subjects will be randomized 1:1:1:1 to receive 1 of 4 treatments (ABY-035 80 mg Q2W, ABY-035 160 mg Q4W, ABY-035 40 mg Q2W, or placebo), 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 Subjects will continue their original treatment of Treatment Period 1 in a double-blinded manner.

Subjects who couldn't achieve an ASAS20 response from baseline are defined as non-responders and eligible for rescue treatment after Week 16 (Visit 9).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

2. Treatment Period 1 (Placebo-Controlled, Double-Blind Period): Day 0 to Week 16 Cohort 1: Eligible subjects will be randomized 1:1:1:1 to receive 1 of 4 treatments, and will remain on their allowable background medication.

Cohort 2: Eligible subjects will be randomized 1:1:1 to receive 1 of 3 treatments , and will remain on their allowable background medication.

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 (Open-label Extension Period): Week 16 to Week 52 Cohort 1: Subjects will receive Group A treatment in an open-label manner. Cohort 2: Subjects will receive Group A treatment in an open-label manner. At Week 24, subjects who could not achieve an ASAS20 response from baseline are defined as non-responders and will discontinue the study treatment.

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : August 24, 2021
Actual Primary Completion Date : July 11, 2022
Actual Study Completion Date : August 30, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Group A
ABY-035 SC injection Cohort 1
Drug: ABY-035
ABY-035 Duration: 52 weeks
Other Name: Izokibep

Active Comparator: Group B
ABY-035 SC injection Cohort 1
Drug: ABY-035
ABY-035 Duration: 52 weeks
Other Name: Izokibep

Active Comparator: Group C
ABY-035 SC injection Cohort 1
Drug: ABY-035
ABY-035 Duration: 52 weeks
Other Name: Izokibep

Placebo Comparator: Group D
Placebo injection Cohort 1
Drug: Normal saline
Dosage form: Solution for injection; Duration: 52 weeks
Other Name: placebo

Active Comparator: Group E
ABY-035 SC injection Cohort 2
Drug: ABY-035
ABY-035 Duration: 52 weeks
Other Name: Izokibep

Active Comparator: Group F
ABY-035 SC injection Cohort 2
Drug: ABY-035
ABY-035 Duration: 52 weeks
Other Name: Izokibep

Placebo Comparator: Group G
Placebo injection Cohort 2
Drug: Normal saline
Dosage form: Solution for injection; Duration: 52 weeks
Other Name: placebo




Primary Outcome Measures :
  1. Proportion of subjects achieving an ASAS40 response [ Time Frame: 16 weeks ]
    The treatment effect


Secondary Outcome Measures :
  1. Change from baseline in BASDAI [ Time Frame: 16 weeks ]
    The treatment effect

  2. Change from baseline in BASFI [ Time Frame: 16 weeks ]
    The treatment effect

  3. Proportion of subjects reaching ASDAS-MI [ Time Frame: 16 weeks ]
    The treatment effect

  4. Incidence of AEs [ Time Frame: 74 weeks ]
    Safety information

  5. Incidence of serious adverse events (SAEs) [ Time Frame: 74 weeks ]
    Safety information

  6. AEs leading to withdrawal from investigational medicinal product (IMP) [ Time Frame: 74 weeks ]
    Safety information

  7. Proportion of subjects achieving an ASAS40 response at Week 2, 24 and 52 [ Time Frame: 52 weeks ]
    The treatment effect

  8. Change from baseline in BASDAI at Week 2, 24 and 52 [ Time Frame: 52 weeks ]
    The treatment effect

  9. Change from baseline in BASFI at Week 2, 24 and 52 [ Time Frame: 52 weeks ]
    The treatment effect

  10. Proportion of subjects reaching ASDAS-MI at Week 24 and 52 [ Time Frame: 52 weeks ]
    The treatment effect



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04795141


Locations
Show Show 47 study locations
Sponsors and Collaborators
Inmagene Biopharmaceuticals
Affibody
Investigators
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Study Director: Sammy Zhu clinical medical director
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Responsible Party: Inmagene Biopharmaceuticals
ClinicalTrials.gov Identifier: NCT04795141    
Other Study ID Numbers: ABY-035-204
First Posted: March 12, 2021    Key Record Dates
Last Update Posted: September 22, 2022
Last Verified: September 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Spondylitis
Spondylarthritis
Spondylitis, Ankylosing
Bone Diseases, Infectious
Infections
Bone Diseases
Musculoskeletal Diseases
Spinal Diseases
Arthritis
Joint Diseases
Spondylarthropathies
Ankylosis