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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02047110
First Posted: January 28, 2014
Last Update Posted: November 16, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Boehringer Ingelheim
Information provided by (Responsible Party):
AbbVie
  Purpose
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
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
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

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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

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 4.2.2.1) 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02047110


  Hide Study Locations
Locations
United States, Colorado
1311.8.10021 Boehringer Ingelheim Investigational Site
Denver, Colorado, United States
United States, Florida
1311.8.10019 Boehringer Ingelheim Investigational Site
Tampa, Florida, United States
United States, Michigan
1311.8.10007 Boehringer Ingelheim Investigational Site
Lansing, Michigan, United States
United States, Pennsylvania
1311.8.10014 Boehringer Ingelheim Investigational Site
Wyomissing, Pennsylvania, United States
United States, South Carolina
1311.8.10002 Boehringer Ingelheim Investigational Site
Charleston, South Carolina, United States
United States, Tennessee
1311.8.10001 Boehringer Ingelheim Investigational Site
Jackson, Tennessee, United States
1311.8.10009 Boehringer Ingelheim Investigational Site
Memphis, Tennessee, United States
Belgium
1311.8.32004 Boehringer Ingelheim Investigational Site
Bruxelles, Belgium
1311.8.32005 Boehringer Ingelheim Investigational Site
Bruxelles, Belgium
1311.8.32001 Boehringer Ingelheim Investigational Site
Gent, Belgium
1311.8.32003 Boehringer Ingelheim Investigational Site
Hasselt, Belgium
1311.8.32002 Boehringer Ingelheim Investigational Site
Leuven, Belgium
Finland
1311.8.35801 Boehringer Ingelheim Investigational Site
Helsinki, Finland
1311.8.35803 Boehringer Ingelheim Investigational Site
Hyvinkää, Finland
France
1311.8.33010 Boehringer Ingelheim Investigational Site
Bordeaux, France
1311.8.33006 Boehringer Ingelheim Investigational Site
Boulogne-Billancourt, France
1311.8.33004 Boehringer Ingelheim Investigational Site
Brest Cedex, France
1311.8.33005 Boehringer Ingelheim Investigational Site
Echirolles Cedex, France
1311.8.33007 Boehringer Ingelheim Investigational Site
Le Kremlin-Bicêtre Cedex, France
1311.8.33003 Boehringer Ingelheim Investigational Site
Montpellier cedex 5, France
1311.8.33009 Boehringer Ingelheim Investigational Site
Orleans cedex 2, France
1311.8.33008 Boehringer Ingelheim Investigational Site
Rennes, France
1311.8.33002 Boehringer Ingelheim Investigational Site
Tours, France
Germany
1311.8.49001 Boehringer Ingelheim Investigational Site
Berlin, Germany
1311.8.49004 Boehringer Ingelheim Investigational Site
Berlin, Germany
1311.8.49007 Boehringer Ingelheim Investigational Site
Herne, Germany
1311.8.49006 Boehringer Ingelheim Investigational Site
Köln, Germany
1311.8.49008 Boehringer Ingelheim Investigational Site
München, Germany
1311.8.49005 Boehringer Ingelheim Investigational Site
Zerbst, Germany
Hong Kong
1311.8.85201 Boehringer Ingelheim Investigational Site
Hong Kong, Hong Kong
1311.8.85202 Boehringer Ingelheim Investigational Site
Hong Kong, Hong Kong
Italy
1311.8.39001 Boehringer Ingelheim Investigational Site
Reggio Emilia, Italy
Korea, Republic of
1311.8.82001 Boehringer Ingelheim Investigational Site
Seoul, Korea, Republic of
1311.8.82003 Boehringer Ingelheim Investigational Site
Seoul, Korea, Republic of
1311.8.82002 Boehringer Ingelheim Investigational Site
Suwon, Korea, Republic of
Netherlands
1311.8.31001 Boehringer Ingelheim Investigational Site
Amsterdam, Netherlands
1311.8.31002 Boehringer Ingelheim Investigational Site
Leiden, Netherlands
Spain
1311.8.34001 Boehringer Ingelheim Investigational Site
A Coruña, Spain
1311.8.34004 Boehringer Ingelheim Investigational Site
Barcelona, Spain
1311.8.34005 Boehringer Ingelheim Investigational Site
La Laguna (Sta Cruz Tenerife), Spain
1311.8.34002 Boehringer Ingelheim Investigational Site
Madrid, Spain
1311.8.34003 Boehringer Ingelheim Investigational Site
Sabadell, Spain
Taiwan
1311.8.88604 Boehringer Ingelheim Investigational Site
Taichung, Taiwan
1311.8.88605 Boehringer Ingelheim Investigational Site
Taichung, Taiwan
1311.8.88601 Boehringer Ingelheim Investigational Site
Taipei, Taiwan
1311.8.88602 Boehringer Ingelheim Investigational Site
Taipei, Taiwan
1311.8.88603 Boehringer Ingelheim Investigational Site
Taipei, Taiwan
Sponsors and Collaborators
AbbVie
Boehringer Ingelheim
Investigators
Study Chair: AbbVie Inc AbbVie
  More Information

Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT02047110     History of Changes
Other Study ID Numbers: 1311.8
2013-003666-13 ( EudraCT Number: EudraCT )
First Submitted: January 24, 2014
First Posted: January 28, 2014
Last Update Posted: November 16, 2016
Last Verified: November 2016

Keywords provided by AbbVie:
ABBV-066
BI 655066
risankizumab

Additional relevant MeSH terms:
Spondylitis
Spondylitis, Ankylosing
Bone Diseases, Infectious
Infection
Bone Diseases
Musculoskeletal Diseases
Spinal Diseases
Spondylarthropathies
Spondylarthritis
Ankylosis
Joint Diseases
Arthritis