A Randomized, Parallel, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ILV-094 Administered Subcutaneously to Subjects with Active Rheumatoid Arthritis on a Stable Background of Methotrexate

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2008-006936-37-HU
• Date of registration: 02/03/2009
• Prospective Registration: Yes
• Primary sponsor: Wyeth Research Division of Wyeth Pharmaceuticals Inc, Clinical Research and Development
• Public title: A Randomized, Parallel, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ILV-094 Administered Subcutaneously to Subjects with Active Rheumatoid Arthritis on a Stable Background of Methotrexate
• Scientific title: A Randomized, Parallel, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ILV-094 Administered Subcutaneously to Subjects with Active Rheumatoid Arthritis on a Stable Background of Methotrexate
• Date of first enrolment: 25/03/2009
• Target sample size: 180
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-006936-37
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no

Countries of recruitment

Belgium, Germany, Hungary, Netherlands

Key inclusion & exclusion criteria

Inclusion criteria:
1. Male or female aged 18 years or older at the time of signing the ICF (or older as required by local regulation or ethics committees).
2. All male and female subjects who are biologically capable of having children must agree and commit to the use of a highly effective method of birth control for the duration of the study and for 12 weeks after the last dose of test article. A subject is still biologically capable of having children if he or she is using contraceptives or if his or her sexual partner is sterile or using contraceptives.
3. Meets the American College of Rheumatology (ACR) 1987 revised criteria for classification of RA for at least 6 months prior to screening.
4. ACR functional class I through III.
5. Active RA at the time of screening and baseline consisting of = 5 swollen and = 5 tender joints (28-joint count) and at least 1 of the following at screening:
a. C-reactive protein (CRP) = 10 mg /L.
b. Erythrocyte sedimentation rate (ESR) (as measured by the Westergren method) = 28 mm/h.
6. Must be receiving methotrexate for at least 12 weeks, with stable route and dose (up to 25 mg weekly according to standard medical practice and local regulation) for at least 8 weeks prior to the expected baseline visit.
7. Negative urine pregnancy test result for all women.

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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
1. Any major illness/condition or evidence of unstable clinical condition (eg, cardiovascular, cerebrovascular, neurologic, metabolic, immunologic, infectious, hepatic, or renal condition; uncontrolled diabetes mellitus; or hypertension) or any serious disorder (eg, current or history of alcohol or drug abuse, current or history of psychiatric disease) that, in the investigator’s judgment, will substantially increase the risk associated with the subject’s participation in and completion of the study, or could preclude the evaluation of the subject’s response, or interfere with the subject’s ability to give informed consent.
2. Pregnant or breastfeeding women or women planning to become pregnant during the study. A urine pregnancy test must be performed during the screening and baseline visits for all women.
3. Subjects with other rheumatic diseases, including but not limited to Lyme disease, psoriatic arthritis, spondyloarthropathy, systemic lupus erythematosus, systemic vasculitis, polymyositis, infectious or reactive arthritis, overlap syndrome, scleroderma, Reiter syndrome, or primary Sjögren syndrome.
4. Cancer or history of cancer (other than adequately treated cutaneous basal cell carcinoma and squamous cell carcinoma of the skin or in situ cervical cancer, with no evidence of recurrence).
5. Contraindications for treatment with methotrexate.
6. Positive for human immunodeficiency virus (HIV) antibodies, hepatitis B surface antigen (HBsAg), and/or hepatitis C antibodies (HCV).
7. History of drug-induced liver injury, liver cirrhosis, or fibrosis at any time before the baseline visit.
8. Laboratory abnormalities at screening including the following:
a. Hemoglobin < 8.5 g/dL (SI units: < 85 g/L)
b. White blood cell (WBC) count < 3.3 x 103/mm3 (SI units: < 3.3 x 109/L)
c. Platelets < 110,000/mm3 or = 1,000,000/mm3 (SI units: < 110 x 109/L or = 1,000 x 109/L)
d. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 1.5 x the upper limit of normal (ULN)
e. Serum creatinine > 2 mg/dL (SI units: > 177 µmol/L)
9. Other clinically significant laboratory, electrocardiogram (ECG), or vital sign abnormalities at screening.
10. Active tuberculosis or history of active tuberculosis. Subjects with latent tuberculosis are allowed if there is documentation of completion of a course of chemoprophylaxis per country-specific medical guidelines. A tuberculosis test, interpreted by the investigator according to local standards or country specific-guidelines, must be performed during the screening visit for subjects with no documentation of tuberculosis test results available within 4 weeks before the baseline visit.
11. Clinically significant finding on chest radiograph within 3 months before the baseline visit. A chest X ray must be obtained during the screening visit for subjects with no documentation of chest X ray results available within 3 months before baseline.
12. Known or suspected allergy or intolerance to any components of test article (refer to the investigator’s brochure), or other compounds related to these classes of medication.
13. Known hypersensitivity reaction to medicine, including biopharmaceutical proteins.
14. Any prior use of B cell-depleting therapy.
15. Receipt within 24 weeks before the baseline visit:
• any investigational biological drugs not listed under the other exclusion criteria
• any cytotoxic agents, including cyclophosphamide (cytoxan), or chlorambucil
• intravenous immunoglobulin (IVIG)
• Proso

Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Rheumatoid Arthritis (RA)
MedDRA version: 9.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis

Intervention(s)

Product Name: ILV-094
Product Code: ILV-094
Pharmaceutical Form: Powder for injection*
Current Sponsor code: ILV-094
Other descriptive name: Recombinant human anti IL-22 monoclonal antibody IgG1
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 50-
Pharmaceutical form of the placebo: Powder for injection*
Route of administration of the placebo: Subcutaneous use

Primary Outcome(s)

Primary end point(s): The primary efficacy endpoint will be ACR20 at week 12.

Main Objective: To assess the safety and efficacy of different dose regimens of ILV-094 compared with placebo, administered subcutaneously to subjects with active Rheumatoid Arthritis on a background of methotrexate.

Secondary Objective: To assess the pharmacokinetic (PK), pharmacodynamic (PD), immunogenicity profile and subject-reported outcomes.

Secondary ID(s)

3199K1-2001-WW