We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Efficacy and Safety of IBI303 in Adult Patients With Active 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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02893254
Recruitment Status : Not yet recruiting
First Posted : September 8, 2016
Last Update Posted : September 21, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
Study of the efficacy and safety of IBI303 compared with adalimumab in adult patients with ankylosing spondylitis (AS) who have had an inadequate response to or who are intolerant to one or more nonsteroidal anti-inflammatory drugs (NSAIDs)

Condition or disease Intervention/treatment Phase
AS Drug: IBI303 Drug: Adalimumab Phase 3

Detailed Description:
Adults patients with active ankylosing spondylitis (AS) were randomized in a 1:1 ratio to receive treatment with adalimumab 40 mg every other week (eow) or IBI303, given subcutaneously (SC), in the 24-week double-blind (DB) phase. Randomized participants received one SC injection of the appropriate DB study medication (adalimumab 40 mg or IBI303) at Week 0 and then eow until Week 22. A follow-up visit occurred 70 days(Week 32) after the last dose of study drug to obtain information on any ongoing or new adverse events (AEs).

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-blind, Parallel-controlled Phase 3 Study Evaluating the Efficacy and Safety of Recombinant Human Monoclonal Antibody Against Human Tumor Necrosis Factor-α (IBI303) Compared to Adalimumab in Patients With Active Ankylosing Spondylitis
Study Start Date : September 2016
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Adalimumab
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: IBI303
IBI303 40mg administered subcutaneously every other week, 12cycles
Drug: IBI303
12 cycles. IBI303: 40 mg, iH
Active Comparator: Adalimumab
Adalimumab 40mg administered subcutaneously every other week
Drug: Adalimumab
12 cycles. Adalimumab: 40mg, iH


Outcome Measures

Primary Outcome Measures :
  1. Number of participants meeting the Assessment of Spondyloarthritis International Society(ASAS) ASAS20 Response Criteria [ Time Frame: Week 24 ]

Secondary Outcome Measures :
  1. Number of participants meeting the ASAS20 Response [ Time Frame: Week 2 ]
  2. Number of participants meeting the ASAS20 Response [ Time Frame: Week 4 ]
  3. Number of participants meeting the ASAS20 Response [ Time Frame: Week 8 ]
  4. Number of participants meeting the ASAS20 Response [ Time Frame: Week 12 ]
  5. Number of participants meeting the ASAS20 Response [ Time Frame: Week 16 ]
  6. Number of participants meeting the ASAS20 Response [ Time Frame: Week 20 ]
  7. Number of participants meeting the ASAS40 Response Criteria [ Time Frame: Week 24 ]
  8. Number of Participants Meeting the ASAS5/6 Response Criteria [ Time Frame: Week 24 ]
  9. Number of Participants Meeting the ASAS Partial Remission [ Time Frame: Week 24 ]
  10. Change from Baseline in Bath Ankylosing Spondylitis Disease Activity Index(BASDAI), in Bath Ankylosing Spondylitis Functional Index(BASFI), in Bath Ankylosing Spondylitis Measure Index(BASMI) [ Time Frame: Baseline and Week 24 ]
  11. Number of participants meeting the ASAS40 Response Criteria [ Time Frame: Week 2 ]
  12. Number of participants meeting the ASAS40 Response Criteria [ Time Frame: Week 4 ]
  13. Number of participants meeting the ASAS40 Response Criteria [ Time Frame: Week 8 ]
  14. Number of participants meeting the ASAS40 Response Criteria [ Time Frame: Week12 ]
  15. Number of participants meeting the ASAS40 Response Criteria [ Time Frame: Week16 ]
  16. Number of participants meeting the ASAS40 Response Criteria [ Time Frame: Week20 ]
  17. Number of Participants Meeting the ASAS5/6 Response Criteria [ Time Frame: Week 2 ]
  18. Number of Participants Meeting the ASAS5/6 Response Criteria [ Time Frame: Week 4 ]
  19. Number of Participants Meeting the ASAS5/6 Response Criteria [ Time Frame: Week 8 ]
  20. Number of Participants Meeting the ASAS5/6 Response Criteria [ Time Frame: Week 12 ]
  21. Number of Participants Meeting the ASAS5/6 Response Criteria [ Time Frame: Week 16 ]
  22. Number of Participants Meeting the ASAS5/6 Response Criteria [ Time Frame: Week 20 ]
  23. Number of Participants Meeting the ASAS Partial Remission [ Time Frame: Week 2 ]
  24. Number of Participants Meeting the ASAS Partial Remission [ Time Frame: Week 4 ]
  25. Number of Participants Meeting the ASAS Partial Remission [ Time Frame: Week 8 ]
  26. Number of Participants Meeting the ASAS Partial Remission [ Time Frame: Week 12 ]
  27. Number of Participants Meeting the ASAS Partial Remission [ Time Frame: Week 16 ]
  28. Number of Participants Meeting the ASAS Partial Remission [ Time Frame: Week 20 ]
  29. Change from Baseline in Bath Ankylosing Spondylitis Disease Activity Index(BASDAI), in Bath Ankylosing Spondylitis Functional Index(BASFI), in Bath Ankylosing Spondylitis Messure Index(BASMI) [ Time Frame: Baseline and Week 2 ]
  30. Change from Baseline in Bath Ankylosing Spondylitis Disease Activity Index(BASDAI), in Bath Ankylosing Spondylitis Functional Index(BASFI), in Bath Ankylosing Spondylitis Messure Index(BASMI) [ Time Frame: Baseline and Week 4 ]
  31. Change from Baseline in Bath Ankylosing Spondylitis Disease Activity Index(BASDAI), in Bath Ankylosing Spondylitis Functional Index(BASFI), in Bath Ankylosing Spondylitis Messure Index(BASMI) [ Time Frame: Baseline and Week 8 ]
  32. Change from Baseline in Bath Ankylosing Spondylitis Disease Activity Index(BASDAI), in Bath Ankylosing Spondylitis Functional Index(BASFI), in Bath Ankylosing Spondylitis Messure Index(BASMI) [ Time Frame: Baseline and Week 12 ]
  33. Change from Baseline in Bath Ankylosing Spondylitis Disease Activity Index(BASDAI), in Bath Ankylosing Spondylitis Functional Index(BASFI), in Bath Ankylosing Spondylitis Messure Index(BASMI) [ Time Frame: Baseline and Week 16 ]
  34. Change from Baseline in Bath Ankylosing Spondylitis Disease Activity Index(BASDAI), in Bath Ankylosing Spondylitis Functional Index(BASFI), in Bath Ankylosing Spondylitis Messure Index(BASMI) [ Time Frame: Baseline and Week 20 ]
  35. Change from Baseline in Patient Global Assessment of Disease Activity [ Time Frame: Baseline and Week 12 ]
  36. Change from Baseline in Patient Global Assessment of Disease Activity [ Time Frame: Baseline and Week 24 ]
  37. Change from Baseline in Total Back Pain Score [ Time Frame: Baseline and Week 12 ]
  38. Change from Baseline in Total Back Pain Score [ Time Frame: Baseline and Week 24 ]
  39. Change From Baseline in Inflammation Score [ Time Frame: Baseline and Week 12 ]
  40. Change From Baseline in Inflammation Score [ Time Frame: Baseline and Week 24 ]
  41. Change from Baseline in Maastricht Ankylosing Spondylitis Enthesis Score(MASES) [ Time Frame: Baseline and Week 12 ]
  42. Change from Baseline in Maastricht Ankylosing Spondylitis Enthesis Score(MASES) [ Time Frame: Baseline and Week 24 ]
  43. Change from Baseline in ASDAS-CRP and ASDAS-ESR [ Time Frame: Baseline and Week 12 ]
  44. Change from Baseline in ASDAS-CRP and ASDAS-ESR [ Time Frame: Baseline and Week 24 ]
  45. Change from Baseline in EQ-5D/WPAI-SHP/HAQ-S QoL [ Time Frame: Baseline and Week 12 ]
  46. Change from Baseline in EQ-5D/WPAI-SHP/HAQ-S QoL [ Time Frame: Baseline and Week 24 ]

Eligibility Criteria

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.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Between 18 and 65 years of age
  2. Fulfilled modified New York Criteria for AS, had active disease(as defined by≥2 of the following: Bath AS Disease Activity Index(BASDAI) ≥4(10cm VAS); total back pain≥40(100mm VAS) and ≥1 hour of morning stiffness)
  3. No response, or inadequate response, or intolerant to≥1 NSAID at least 4 weeks
  4. Participants who are regularly taking DMARDs(SSZ≤3g/day,MTX≤15mg/week) as part of their AS therapy are required to be on a stable dose ≥28 days prior to Baseline, and are required to be on a stable DMARDs dose and to accept oral folic acid therapy(≥5mg/week) during the study period;
  5. Participants who are regularly taking NSAIDs as part of their AS therapy are required to be on a stable dose ≥14 days prior to Baseline, and are required to be on a stable dose during the study period;
  6. Glucocorticoid must be withdrawn for at least 4 weeks prior to Baseline, and were not allowed during the study period.
  7. Total duration of prior physical therapy should be at least 2 weeks
  8. Traditional Chinese medicines to AS must be withdrawn for at least 28 days prior to Baseline, and were not allowed during the study period.
  9. Biological agents must be withdrawn: etanercept and anakinra(IL-1 receptor antagonist) for at least 4 weeks prior to administration; tocilizumab(IL-6 monoclonal antibody) for at least 12 weeks prior to administration; other biological agents for 12 weeks or 5 half-lives(whichever is longer) prior to administration
  10. Male subjects' partner, or female subjects should be willing to use adequate contraception from admission to clinical research center until 5 months post dosing;
  11. To fully understanding the purpose of the study, to understand the pharmacological action of the study drugs and the possible adverse reactions; participants who are voluntary to sign the informed consent according to the Declaration of Helsinki
  12. Blood routine examination: hemoglobin ≥90g/L, WBC count ≥3.5×109/L, PLT count ≥100×109/L; liver function examination: total bilirubin(TBIL), direct bilirubin(DBIL), aspartate transaminase(AST) or alanine aminotransferase (ALT) <1.5×ULN; kidney function examination:creatinine(Cr) ≤ULM, usea nitrogen(BUN) ≤1.25×ULN

Exclusion Criteria:

  1. No response to prior tumor necrosis factor-α inhibitors treatment
  2. Use of DMARD(except for sulfasalazine or methotrexate) within 4 weeks prior to Baseline
  3. Use of opioid analgesics(such as methadone, morphine) within 4 weeks prior to Baseline
  4. X-ray suggests total spinal ankylosis, or sacroiliac joint fusion
  5. Patients with moderate to severe congestive heart failure(NYHA )
  6. Has received intra-articular joint injection(s), spinal or paraspinal injection(s) with corticosteroids within 28 days prior to Baseline
  7. Has undergone spinal surgery or joint surgery within 2 months prior to the administration of the study drugs
  8. Patients with other rheumatic diseases or immunodeficiency, including inflammatory bowel disease(IBD), psoriasis, active uveitis
  9. Recent active or chronic infection requiring anti-infective therapy, such as M.tuberculosis, Listeriosis, Histophasmosis
  10. Tuberculosis(TB) history, or a positive T-SPOT test, or chest radiograph suggests active TB
  11. Positive serology for human immunodeficiency virus(HIV) antibody
  12. Positive serology for hepatitis C virus antibody
  13. Active or chronic HBV infection, such as positive hepatitis B virus surface antigen
  14. Malignancy history ≤5 years(except for successfully treated cutaneous squamous cell carcinoma, or basal cell carcinoma, or localized cervical carcinoma in situ, or breast ductal carcinoma in situ)
  15. History of relevant allergy/hypersensitivity (including allergy to the study medications or its excipients)
  16. Prior or recent central nervous system demyelinating disease or multiple sclerosis
  17. Use of live vaccines within 3 months prior to Baseline
  18. Pregnant or breastfeeding women
  19. Suspected or confirmed drug/alcohol use
  20. Participation in another interventional trial within 3 months prior to administration
  21. Subjects with serious psychiatric or nervous system diseases, or patients who have difficulty in informing consent or AE presentation, or illiterate patients
  22. Subjects who are unable to complete the study, or who may not be able to comply with the requirement of the study, judged by the investigators
Contacts and Locations

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): NCT02893254


Contacts
Contact: Hui Zhou 8651269566088 ext 8067 hui.zhou@innoventbio.com

Sponsors and Collaborators
Innovent Biologics (Suzhou) Co. Ltd.
Investigators
Principal Investigator: Huji Xu Shanghai Changzheng Hospital
More Information

Publications:
Responsible Party: Innovent Biologics (Suzhou) Co. Ltd.
ClinicalTrials.gov Identifier: NCT02893254     History of Changes
Other Study ID Numbers: CIBI303A301
First Posted: September 8, 2016    Key Record Dates
Last Update Posted: September 21, 2016
Last Verified: September 2016

Keywords provided by Innovent Biologics (Suzhou) Co. Ltd.:
ankylosing spondylitis, tumor necrosis factor-α inhibitors

Additional relevant MeSH terms:
Spondylitis
Spondylitis, Ankylosing
Bone Diseases, Infectious
Infection
Bone Diseases
Musculoskeletal Diseases
Spinal Diseases
Spondylarthropathies
Spondylarthritis
Ankylosis
Joint Diseases
Arthritis
Adalimumab
Anti-Inflammatory Agents
Antirheumatic Agents