Rheumatoid Arthritis MedDRA version: 14.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Conditions
Interventions
Product Name: Olikizumab
Product Code: CDP6038
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Olokizumab
CAS Number: 1007223-17-7
Current Sponsor code: CDP6038
Other descriptive name
Sponsors
UCB Biosciences, Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: To be eligible to participate in this study, all of the following criteria must be met: 1. Subject must be able to understand the information provided to them, be given ample time and opportunity to ask questions and to decide whether or not to participate, and provide written informed consent. The subject should also be able to communicate satisfactorily with the Investigator and be willing to participate in the study and to comply with all study requirements. 2. Subject must be at least 18 years old at Screening and weigh =40kg. 3. Subject must have a diagnosis of adult-onset RA of at least 6 months’ (24 weeks) duration as defined by the 1987 ACR classification criteria (Arnett et al, 1988) or a score of =6 as defined by the ACR/European League Against Rheumatism Classification and Diagnostic Criteria for RA (Aletaha et al, 2010). 4. Subject must have moderately to severely active RA disease as defined by each of the following: ? =6 tender joints (68-joint count) at Screening and Baseline ? =6 swollen joints (66-joint count) at Screening and Baseline ? CRP =1.2 times the upper limit of normal (ULN) (central laboratory) or ESR >28mm/hour (Westergren) 5. Subject must be on a dose of MTX between 15 to 25mg/week, which has been stable for at least 6 weeks prior to Screening with a stable route of administration. Subjects may be dosed with 10 to less than 15mg weekly if they have documented reasons of toxicity. Subjects must be willing to initiate, or continue on, folate supplementation while taking MTX during the study (see Section 7.8.1). 6. Subject must have had intolerance or inadequate response to treatment (ie, TNF-blocker failure) with no more than 2 licensed TNF-blocker therapies (etanercept, infliximab, golimumab, certolizumab pegol, or adalimumab) prior to study entry. 7. Female subjects must be either postmenopausal for at least 1 year, surgically incapable of childbearing, or effectively practicing an acceptable method of contraception (either oral/parenteral/implantable hormonal contraceptives, intrauterine device, or barrier and spermicide). Abstinence is not considered an acceptable method of contraception for this study. Female subjects of childbearing potential must agree to use adequate contraception during the study and for 6 months (24 weeks) after their last CDP6038 dose. Male subjects must agree to ensure that they or their female partner(s) use adequate contraception during the study and for 12 weeks after the subject receives their last dose of CDP6038. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 220 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Rheumatoid arthritis disease-related and other treatment-related exclusions: 1. Subjects who have a diagnosis of any other inflammatory arthritis (eg, psoriatic arthritis, ankylosing spondylitis, or gout, or lupus or Sjögren’s syndrome (primary or secondary). 2. Subjects who have a secondary, noninflammatory type of arthritis (eg, osteoarthritis or fibromyalgia) that in the Investigator’s opinion is symptomatic enough to interfere with evaluation of the effect of IMP on the subject’s primary diagnosis of RA. 3. Subject who is Steinbrocker IV functional capacity. 4. Subjects must be free of the prohibited medications (as detailed in section 6.2 of the study protocol) 5. Subjects must be free of biological therapy (as detailed in section 6.2 of the study protocol) 6. Participation in any other clinical drug or device study (including a biologic product) within 12 weeks or 5 half-lives, or within protocol-specified durations for specific agents, whichever is longer, prior to Baseline. Medical history-related exclusions: 7. Subject has a creatinine level, an alanine aminotransferase (ALT) or aspartate aminotransferase (AST) level, platelets or a white blood cell count, or a neutrophil count at Screening in accordance with the protocol parameters (refer to protocol). 8. Female subjects who are breast-feeding, pregnant, or plan to become pregnant during the study or within 24 weeks following last dose of IMP. 9. Subjects who have a history of an infected joint prosthesis at any time with that prosthesis still in situ. 10. Subject with a history of chronic or recurrent infections (refer to protocol). 11. Subjects with known history of or current clinically active infection with Histoplasma, Coccidiodes, Paracoccidioides, Pneumocystis, nontuberculous mycobacteria, Blastomyces, or Aspergillus. 12. Subjects at high risk of infection (eg, presence of leg ulcers or an indwelling urinary catheter, bedridden, or wheelchair-bound subjects). 13. Subjects with known concurrent acute or chronic viral hepatitis B or C infection. 14. Subjects with known human immunodeficiency virus (HIV) infection. 15. Subject has: a) known TB disease, b) high risk of acquiring TB infection, c) a positive or indeterminate TB test result, or d) radiographic evidence of TB (refer to protocol). 16. Subjects that have received vaccinations within 8 weeks prior to Screening or plan to receive vaccines during the study (with the exception of injectable influenza and pneumococcal vaccinations which are permitted). 17. Concurrent malignancy or a history of malignancy (refer to protocol). 18. Subjects with a history of a lymphoproliferative disorder, including lymphoma or signs and symptoms suggestive of lymphoproliferative disease. 19. Subjects with a history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, dermatological, neurological, psychiatric, hematological (including bleeding disorder), or immunologic/immunodeficiency disorder(s) which are clinically significant enough in the opinion of the Investigator or Sponsor to alter the absorption and disposition of IMP, or constitute a possible confounding factor for assessment of efficacy or safety of the IMP. 20. Subjects with a current or recent history of severe, progressive, and/or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac (including but not limited to familial hypertriglyceridemia and Class III or IV c
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to evaluate the efficacy of CDP6038 administered sc at various doses and dose administration frequencies relative to placebo.;Secondary Objective: The secondary objectives of this study are: • To evaluate the safety of CDP6038 at various doses and dose administration frequencies relative to placebo • To assess the PK and immunogenicity of repeated doses of CDP6038 • To assess the dose- and exposure-response relationships of CDP6038 with efficacy;Primary end point(s): Efficacy variables The primary efficacy variable is the change from Baseline in the DAS28(CRP) for CDP6038 and placebo. Primary pharmacokinetic/pharmacodynamic variables Dose leading to 50% of the maximum effect (D50) on DAS28(CRP) • Exposure leading to 50% of the maximum effect on DAS28(CRP) • Concentration leading to 50% of the maximum effect (EC50) on DAS28(CRP) • Slope of effect (?) on DAS28(CRP);Timepoint(s) of evaluation of this end point: Efficacy variables The primary efficacy variable is the change from Baseline in the DAS28(CRP) at Week 12 for CDP6038 and placebo. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary efficacy variables are the ACR20, ACR50, and ACR70 response rates at for CDP6038 and placebo.;Timepoint(s) of evaluation of this end point: The secondary efficacy variables are the ACR20, ACR50, and ACR70 response rates at Week 12 for CDP6038 and placebo. | — |
Countries
United Kingdom, United States
Outcome results
None listed