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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Boehringer Ingelheim
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT02047110
First received: January 24, 2014
Last updated: August 20, 2014
Last verified: August 2014
  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
Endpoint Classification: Efficacy Study
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 Boehringer Ingelheim:

Primary Outcome Measures:
  • Assessment of Spondyloarthritis International Society (ASAS) 40 response [ Time Frame: Week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in Ankylosing Spondylitis Disease Activity Score (ASDAS) score as compared to baseline (Key Secondary) [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Assessment of Spondyloarthritis International Society (ASAS) 5/6 response [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Assessment of Spondyloarthritis International Society (ASAS) remission criteria [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Assessment of Spondyloarthritis International Society (ASAS) 20 response [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Assessment of Spondyloarthritis International Society (ASAS) 40 response [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
  • Change in Bath Ankylosing Spondylitis Disease Activity Score (BASDAI) score as compared with baseline [ Time Frame: Week 12 ] [ Designated as safety issue: No ]

Estimated Enrollment: 160
Study Start Date: January 2014
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: December 2014 (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
Experimental: Arm 2
BI 655066 s.c.
Drug: BI 655066
Medium Dose
Experimental: Arm 3
BI 655066 s.c.
Drug: BI 655066
High Dose

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
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 ClinicalTrials.gov identifier: NCT02047110

Contacts
Contact: Boehringer Ingelheim Call Center 1-800-243-0127 clintriage.rdg@boehringer-ingelheim.com

  Show 52 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

No publications provided

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02047110     History of Changes
Other Study ID Numbers: 1311.8, 2013-003666-13
Study First Received: January 24, 2014
Last Updated: August 20, 2014
Health Authority: Belgium: Federal Agency for Medicinal and Health Products
Finland: Finnish Medicines Agency
France: Agence Nationale de Sécurité du Médicament et des produits de santé
Germany: Paul-Ehrlich-Institut
Hong Kong: Department of Health
Italy: Ethics Committee
Korea: Ministry of Food and Drug Safety
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Spain: Spanish Agency of Medicines
Taiwan : Food and Drug Administration
United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on August 28, 2014