Efficacy and Safety of IBI303 in Adult Patients With Active Ankylosing Spondylitis

NCT02893254 | Completed Phase 3

• 1 other identifier: CIBI303A301
• Study Type: interventional
• Target: 438
• Locations: 0 countries
• Sites: N/A

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)

Conditions

AS

Keywords

ankylosing spondylitis, tumor necrosis factor-α inhibitors

Outcome Measures

Primary Outcomes (1)

• Number of participants meeting the Assessment of Spondyloarthritis International Society(ASAS) ASAS20 Response Criteria

  Week 24

Secondary Outcomes (46)

• Number of participants meeting the ASAS20 Response

  Week 2

• Number of participants meeting the ASAS20 Response

  Week 4

• Number of participants meeting the ASAS20 Response

  Week 8

• Number of participants meeting the ASAS20 Response

  Week 12

• Number of participants meeting the ASAS20 Response

  Week 16

Study Arms (2)

IBI303

EXPERIMENTAL

IBI303 40mg administered subcutaneously every other week, 12cycles

Drug: IBI303

Adalimumab

ACTIVE COMPARATOR

Adalimumab 40mg administered subcutaneously every other week

Drug: Adalimumab

Interventions

IBI303 DRUG

12 cycles. IBI303: 40 mg, iH

IBI303

Adalimumab DRUG

12 cycles. Adalimumab: 40mg, iH

Adalimumab

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Between 18 and 65 years of age
• 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）
• No response, or inadequate response, or intolerant to≥1 NSAID at least 4 weeks
• 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；
• 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；
• Glucocorticoid must be withdrawn for at least 4 weeks prior to Baseline, and were not allowed during the study period.
• Total duration of prior physical therapy should be at least 2 weeks
• Traditional Chinese medicines to AS must be withdrawn for at least 28 days prior to Baseline, and were not allowed during the study period.
• 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
• Male subjects' partner, or female subjects should be willing to use adequate contraception from admission to clinical research center until 5 months post dosing；
• 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
• 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

You may not qualify if:

• No response to prior tumor necrosis factor-α inhibitors treatment
• Use of DMARD(except for sulfasalazine or methotrexate) within 4 weeks prior to Baseline
• Use of opioid analgesics(such as methadone, morphine) within 4 weeks prior to Baseline
• X-ray suggests total spinal ankylosis, or sacroiliac joint fusion
• Patients with moderate to severe congestive heart failure（NYHA ）
• Has received intra-articular joint injection(s), spinal or paraspinal injection(s) with corticosteroids within 28 days prior to Baseline
• Has undergone spinal surgery or joint surgery within 2 months prior to the administration of the study drugs
• Patients with other rheumatic diseases or immunodeficiency, including inflammatory bowel disease(IBD), psoriasis, active uveitis
• Recent active or chronic infection requiring anti-infective therapy, such as M.tuberculosis, Listeriosis, Histophasmosis
• Tuberculosis(TB) history, or a positive T-SPOT test, or chest radiograph suggests active TB
• Positive serology for human immunodeficiency virus(HIV) antibody
• Positive serology for hepatitis C virus antibody
• Active or chronic HBV infection, such as positive hepatitis B virus surface antigen
• 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）
• History of relevant allergy/hypersensitivity (including allergy to the study medications or its excipients)

Sponsors & Collaborators

• Innovent Biologics (Suzhou) Co. Ltd.: lead

Related Publications (2)

• Huang F, Gu J, Zhu P, Bao C, Xu J, Xu H, Wu H, Wang G, Shi Q, Andhivarothai N, Anderson J, Pangan AL. Efficacy and safety of adalimumab in Chinese adults with active ankylosing spondylitis: results of a randomised, controlled trial. Ann Rheum Dis. 2014 Mar;73(3):587-94. doi: 10.1136/annrheumdis-2012-202533. Epub 2013 Mar 8.

  PMID: 23475983 RESULT

• Xu H, Li Z, Wu J, Xing Q, Shi G, Li J, Liu X, Wu L, Li X, Tan W, He D, Bi L, Li H, Xiao Z, Shuai Z, Li X, Wang Y, Luo L, Zheng Y, Xiao W, Wu X, Zhou L, Li T, Qian L, Zhou H, Lu S, Zheng S, Xiong Y, Wang X, Wang Y, Wu X. IBI303, a biosimilar to adalimumab, for the treatment of patients with ankylosing spondylitis in China: a randomised, double-blind, phase 3 equivalence trial. Lancet Rheumatol. 2019 Sep;1(1):e35-e43. doi: 10.1016/S2665-9913(19)30013-X. Epub 2019 Aug 28.

  PMID: 38229357 DERIVED

MeSH Terms

Conditions

Spondylitis, Ankylosing

Interventions

Adalimumab

Condition Hierarchy (Ancestors)

Axial Spondyloarthritis; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Ankylosis; Joint Diseases; Arthritis

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Huji Xu

  Shanghai Changzheng Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2016
• First Posted: September 8, 2016
• Study Start: September 22, 2016
• Primary Completion: January 22, 2018
• Study Completion: March 16, 2018
• Last Updated: June 4, 2018

Record last verified: 2018-06