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BI 655066 Proof of Concept Dose Finding Study in Ankylosing Spondylitis (AS)

This study has been completed.
Boehringer Ingelheim
Information provided by (Responsible Party):
AbbVie Identifier:
First received: January 24, 2014
Last updated: November 15, 2016
Last verified: November 2016
The overall purpose of the trial is to assess the clinical efficacy of three different subcutaneous doses of BI 655066 in adult patients with AS, in order to provide clinical proof of concept and to select dose (s) for confirmatory clinical trials.

Condition Intervention Phase
Spondylitis, Ankylosing
Drug: Placebo
Drug: BI 655066
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:

Further study details as provided by AbbVie:

Primary Outcome Measures:
  • Assessment of Spondyloarthritis International Society (ASAS) 40 response [ Time Frame: Week 12 ]

Secondary Outcome Measures:
  • Change in Ankylosing Spondylitis Disease Activity Score (ASDAS) score as compared to baseline (Key Secondary) [ Time Frame: Week 12 ]
  • Assessment of Spondyloarthritis International Society (ASAS) 5/6 response [ Time Frame: Week 12 ]
  • Assessment of Spondyloarthritis International Society (ASAS) remission criteria [ Time Frame: Week 12 ]
  • Assessment of Spondyloarthritis International Society (ASAS) 20 response [ Time Frame: Week 12 ]
  • Assessment of Spondyloarthritis International Society (ASAS) 40 response [ Time Frame: Week 24 ]
  • Change in Bath Ankylosing Spondylitis Disease Activity Score (BASDAI) score as compared with baseline [ Time Frame: Week 12 ]

Enrollment: 159
Study Start Date: January 2014
Study Completion Date: July 2016
Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Arm 4
s.c. injections placebo
Drug: Placebo
Experimental: Arm 1
BI 655066 s.c.
Drug: BI 655066
Low Dose
Other Names:
  • ABBV-066
  • risankizumab
Experimental: Arm 2
BI 655066 s.c.
Drug: BI 655066
Medium Dose
Other Names:
  • ABBV-066
  • risankizumab
Experimental: Arm 3
BI 655066 s.c.
Drug: BI 655066
High Dose
Other Names:
  • ABBV-066
  • risankizumab


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion criteria:

  1. Male and female patients
  2. Age = 18 years and = 70 years
  3. Definite AS based on the modified New York criteria (1984)
  4. Documented disease duration >= 3 months at screening
  5. Active disease at screening, defined as:

    1. BASDAI score (0-10) >= 4, AND
    2. Spinal pain level assessed by the 2nd BASDAI question (0-10) >= 4
  6. 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
  7. 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
  8. Patients (males or females) receiving background MTX or Leflunomide therapy who are following the national regulatory guidelines regarding contraception
  9. Signed and dated written informed consent prior to admission to the study in accordance with GCP and local legislation

Exclusion criteria:

  1. 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)
  2. Patient previously treated with any biological immunomodulating agent for AS, either licensed or experimental
  3. 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)
  4. 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
  5. Active uveitis or inflammatory bowel disease at screening
  6. Diagnosed psoriatic arthritis at screening, satisfying the modified New York criteria
  7. Patients who had received intraarticular injection(s) with corticosteroids within 4 weeks prior to screening visit
  8. Patients who must or wish to continue the intake of restricted medications (cf. Section or any drug considered likely to interfere with the safe conduct of the study
  9. Major surgery performed within 8 weeks prior to screening or planned within 12 months after screening (e.g. hip replacement)
  10. 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
  11. 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
  12. 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.
  13. History of allergy/hypersensitivity to a systemically administered biologic agent or its excipients
  14. History of alcohol abuse within last 12 months (intake of more than 30 g/day)
  15. History of drug abuse within last 12 months
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT02047110

  Show 47 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim
Study Chair: AbbVie Inc AbbVie
  More Information

Responsible Party: AbbVie Identifier: NCT02047110     History of Changes
Other Study ID Numbers: 1311.8
2013-003666-13 ( EudraCT Number: EudraCT )
Study First Received: January 24, 2014
Last Updated: November 15, 2016

Keywords provided by AbbVie:
BI 655066

Additional relevant MeSH terms:
Spondylitis, Ankylosing
Bone Diseases, Infectious
Bone Diseases
Musculoskeletal Diseases
Spinal Diseases
Joint Diseases
Arthritis processed this record on May 25, 2017