- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02047110
BI 655066 (Risankizumab) Proof of Concept Dose Finding Study in Ankylosing Spondylitis (AS)
A 48 Weeks, Phase II, Randomized, Double-blind, Placebo-controlled, Proof of Concept and Dose Finding Study of Three Different Dose Regimens of BI 655066 Administered Subcutaneously in Patients With Ankylosing Spondylitis.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 2
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion criteria:
- Male and female patients
- Age = 18 years and = 70 years
- Definite AS based on the modified New York criteria (1984)
- Documented disease duration = 3 months at screening
Active disease at screening, defined as:
- BASDAI score (0-10) = 4, AND
- Spinal pain level assessed by the 2nd BASDAI question (0-10) = 4
- Have either a documented inadequate response for axial symptoms to 30 days of optimal daily doses of at least two non-steroidal anti-inflammatory drugs (NSAIDs), or documented intolerance to NSAIDs
Female patients who meet any of the following criteria from screening visit up to the End of Observation visit (EOO):
- using adequate contraception, e.g. any of the following methods plus condom: implants, injectables, combined oral contraceptives, intrauterine device (IUD)
- sexually abstinent
- have a vasectomised sexual partner (vasectomy at least 1 year prior to enrolment)
- surgically sterilised (including hysterectomy)
- postmenopausal defined as at least 1 year of spontaneous Amenorrhea
- Patients (males or females) receiving background MTX or Leflunomide therapy who are following the national regulatory guidelines regarding contraception
- Signed and dated written informed consent prior to admission to the study in accordance with GCP and local legislation
Exclusion criteria:
- Radiographic evidence of total ankylosis of the spine at screening or before (spinal XRay examinations at screening visit/ during screening period are not mandatory ¿ see footnote 12 from Flow-Chart 1)
- Patient previously treated with any biological immunomodulating agent for AS, either licensed or experimental
- Previous or current participation in a clinical trial testing an investigational drug for AS within 12 weeks prior to randomization (any biological immunomodulating agents are excluded)
- Usage of any investigational drug within 30 days prior to randomization or the planned use of an investigational drug during the course of the actual study
- Active uveitis or inflammatory bowel disease at screening
- Diagnosed psoriatic arthritis at screening, satisfying the modified New York criteria
- Patients who had received intraarticular injection(s) with corticosteroids within 4 weeks prior to screening visit
- Patients who must or wish to continue the intake of restricted medications (cf. Section 4.2.2.1) or any drug considered likely to interfere with the safe conduct of the study
- Major surgery performed within 8 weeks prior to screening or planned within 12 months after screening (e.g. hip replacement)
Chronic or relevant acute infections including HIV, viral hepatitis and tuberculosis (positive tests for HIV, HBV/HCV at screening will be exclusionary)
For tuberculosis patients, they are not eligible according to the following screening criteria:
- Have signs or symptoms suggestive of current active or latent TB upon medical history, physical examination and/or a chest radiograph (both posterior-anterior and lateral views, taken within 3 months prior to the first administration of study drug and read by a qualified radiologist)
- Have history of latent or active TB prior to screening, except for patients who have documentation of having completed an adequate treatment regimen at least 6 months prior to the first administration of study agent
- Have positive QuantiFERON-TB Gold In-Tube test within 2 months prior to or during screening, in which active TB has not been ruled out, except for patients with history of latent TB and documentation of having completed an adequate treatment regimen at least 6 months prior to the first administration of study agent
- Any documented active or suspected malignancy or history of malignancy within 5 years prior to screening, except appropriately treated basal cell carcinoma of the skin or in situ carcinoma of uterine cervix
- Evidence of current or previous clinically significant disease, medical condition other than AS, finding of the medical examination (including vital signs and ECG), or laboratory value at the screening visit outside the reference range that is of clinical relevance, that in the opinion of the Investigator, would compromise the safety of the patient or the quality of the data. This criterion provides an opportunity for the investigator to exclude patients based on clinical judgment, even if other eligibility criteria are satisfied.
- History of allergy/hypersensitivity to a systemically administered biologic agent or its excipients
- History of alcohol abuse within last 12 months (intake of more than 30 g/day)
- History of drug abuse within last 12 months
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
Subcutaneous injection of Placebo (solution for injection matching risankizumab, 1 mL pre-filled syringe) administered every 8 weeks (At Day1 and at Weeks 8, 16, and 24) up to 4 times during the regular treatment period.
|
Placebo for risankizumab administered by subcutaneous (SC) injection
|
Experimental: Risankizumab 18 mg
Subcutaneous injection of risankizumab 18 mg administered every 8 weeks at Day 1 only, followed by placebo every 8 weeks (i.e. at Week 8, 16 and 24), up to a total duration of 24 weeks
|
Risankizumab administered by subcutaneous (SC) injection
Other Names:
|
Experimental: Risankizumab 90 mg
Subcutaneous injection of risankizumab 90 mg administered every 8 weeks (At Day1 and at Weeks 8, 16, and 24) up to 4 times during the regular treatment period
|
Risankizumab administered by subcutaneous (SC) injection
Other Names:
|
Experimental: Risankizumab 180 mg
Subcutaneous injection of risankizumab 180 mg administered every 8 weeks (At Day1 and at Weeks 8, 16, and 24) up to 4 times during the regular treatment period
|
Risankizumab administered by subcutaneous (SC) injection
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Patients Who Achieved Assessment of Spondyloarthritis International Society (ASAS) 40 Improvement Criteria at Week 12.
Time Frame: Week 12
|
ASAS 40 evaluations are based on the following 4 components (also called domains) that include patient' self-assessments on a numerical rating scale (NRS) from 0 to 10 with higher numbers representing a worse disease status:
|
Week 12
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline to Week 12 in Disease Activity Assessed by the Ankylosing Spondylitis Disease Activity Score (ASDAS).
Time Frame: Baseline and Week 12
|
This is the key secondary endpoint.
ASDAS is a linear function of Back Pain (Question 2 from Bath Ankylosing Spondylitis (AS) Disease Activity Index (BASDAI): range 0-10), Duration of Morning Stiffness (Question 6 from BASDAI: range 0-10), Patient's global assessment of the disease on Numerical rating Scale (NRS) (range 0-10), peripheral joint pain/swelling (Question 3 from BASDAI: range 0-10) and the C-reactive protein (CRP) lab value at the visit.
ASDAS-CRP: 0.121*Back pain +0.058*Duration of Morning Stiffness +0.11*Patient Global + 0.073*Peripheral pain/ Swelling + 0.579*Ln (CRP +1).
For all of the scales that make up the ASDAS, higher indicates worse disease.
|
Baseline and Week 12
|
Percentage of Patients Who Achieved ASAS 5/6 Improvement Criteria at Week 12
Time Frame: Week 12
|
The ASAS 5/6 evaluation is based on 6 components:
|
Week 12
|
Percentage of Patients Who Achieved Partial Remission According to the ASAS Criteria at Week 12
Time Frame: Week 12
|
Percentage of patients who achieved partial remission according to the ASAS criteria at Week 12 is presented
|
Week 12
|
Percentage of Patients Who Achieved ASAS 20 Improvement Criteria at Week 12
Time Frame: Week 12
|
ASAS 20 evaluations are based on the following 4 components (also called domains) that include patient' self-assessments on a numerical rating scale (NRS) from 0 to 10 with higher numbers representing a worse disease status:
|
Week 12
|
Change From Baseline to Week 12 in Disease Activity Assessed by BASDAI
Time Frame: Baseline and Week 12
|
BASDAI assesses the AS disease activity of a patient within the last week based on 6 questions on a NRS (1 to 10) How would you describe the overall level of
A score of 10 means very severe disease activity for each of the BASDAI questions 1, 2, 3, 4 and 5. BASDAI question 6 addresses the stiffness duration. A NRS of 0 means 0 h; a NRS of 10 mean ≥2 h. The BASDAI was computed in the following way: the sum of the values of question 1 to 4 was calculated and the mean of questions 5 and 6 was added. This value was divided by 5. |
Baseline and Week 12
|
Percentage of Patients Who Achieved ASAS 40 Improvement Criteria at Week 24
Time Frame: Week 24
|
Percentage of patients who achieved ASAS 40 improvement criteria at Week 24 is presented
|
Week 24
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1311.8
- 2013-003666-13 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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