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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

Tracking Information
First Submitted Date  ICMJE March 3, 2021
First Posted Date  ICMJE March 12, 2021
Last Update Posted Date September 22, 2022
Actual Study Start Date  ICMJE August 24, 2021
Actual Primary Completion Date July 11, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 10, 2021)
Proportion of subjects achieving an ASAS40 response [ Time Frame: 16 weeks ]
The treatment effect
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 10, 2021)
  • Change from baseline in BASDAI [ Time Frame: 16 weeks ]
    The treatment effect
  • Change from baseline in BASFI [ Time Frame: 16 weeks ]
    The treatment effect
  • Proportion of subjects reaching ASDAS-MI [ Time Frame: 16 weeks ]
    The treatment effect
  • Incidence of AEs [ Time Frame: 74 weeks ]
    Safety information
  • Incidence of serious adverse events (SAEs) [ Time Frame: 74 weeks ]
    Safety information
  • AEs leading to withdrawal from investigational medicinal product (IMP) [ Time Frame: 74 weeks ]
    Safety information
  • Proportion of subjects achieving an ASAS40 response at Week 2, 24 and 52 [ Time Frame: 52 weeks ]
    The treatment effect
  • Change from baseline in BASDAI at Week 2, 24 and 52 [ Time Frame: 52 weeks ]
    The treatment effect
  • Change from baseline in BASFI at Week 2, 24 and 52 [ Time Frame: 52 weeks ]
    The treatment effect
  • Proportion of subjects reaching ASDAS-MI at Week 24 and 52 [ Time Frame: 52 weeks ]
    The treatment effect
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE ABY-035 in the Treatment of Subjects With Ankylosing Spondylitis
Official Title  ICMJE 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
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:

  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).

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE 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
Condition  ICMJE Ankylosing Spondylitis
Intervention  ICMJE
  • Drug: ABY-035
    ABY-035 Duration: 52 weeks
    Other Name: Izokibep
  • Drug: Normal saline
    Dosage form: Solution for injection; Duration: 52 weeks
    Other Name: placebo
Study Arms  ICMJE
  • Active Comparator: Group A
    ABY-035 SC injection Cohort 1
    Intervention: Drug: ABY-035
  • Active Comparator: Group B
    ABY-035 SC injection Cohort 1
    Intervention: Drug: ABY-035
  • Active Comparator: Group C
    ABY-035 SC injection Cohort 1
    Intervention: Drug: ABY-035
  • Placebo Comparator: Group D
    Placebo injection Cohort 1
    Intervention: Drug: Normal saline
  • Active Comparator: Group E
    ABY-035 SC injection Cohort 2
    Intervention: Drug: ABY-035
  • Active Comparator: Group F
    ABY-035 SC injection Cohort 2
    Intervention: Drug: ABY-035
  • Placebo Comparator: Group G
    Placebo injection Cohort 2
    Intervention: Drug: Normal saline
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: September 21, 2022)
25
Original Estimated Enrollment  ICMJE
 (submitted: March 10, 2021)
300
Actual Study Completion Date  ICMJE August 30, 2022
Actual Primary Completion Date July 11, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China,   Korea, Republic of,   United States
Removed Location Countries Cayman Islands
 
Administrative Information
NCT Number  ICMJE NCT04795141
Other Study ID Numbers  ICMJE ABY-035-204
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Inmagene Biopharmaceuticals
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Inmagene Biopharmaceuticals
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Affibody
Investigators  ICMJE
Study Director: Sammy Zhu clinical medical director
PRS Account Inmagene Biopharmaceuticals
Verification Date September 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP