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

NCT02047110 | Completed Phase 2 Results

• 2 other identifiers: 1311.82013-003666-13
• Study Type: interventional
• Target: 159
• Locations: 0 countries
• Sites: N/A

Brief Summary

The overall purpose of the trial is to assess the clinical efficacy of three different subcutaneous doses of BI 655066 (risankizumab) in adult patients with AS, in order to provide clinical proof of concept and to select dose (s) for confirmatory clinical trials.

Conditions

Ankylosing Spondylitis (AS)

Outcome Measures

Primary Outcomes (1)

• Percentage of Patients Who Achieved Assessment of Spondyloarthritis International Society (ASAS) 40 Improvement Criteria at 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: * Global AS disease activity * Inflammation based on the mean of Bath AS Disease Activity Index (BASDAI) questions addressing the level of morning stiffness and duration * Spinal pain based on the mean of 2 questions * Physical function based on the Bath AS Functional Index (BASFI) The ASAS 40 response is defined as an improvement in 3 of 4 components and no worsening in the remaining component; an improvement is defined as a reduction from baseline of ≥40% and an absolute reduction of ≥2 units in each of the 3 components.

  Week 12

Secondary Outcomes (6)

• Change From Baseline to Week 12 in Disease Activity Assessed by the Ankylosing Spondylitis Disease Activity Score (ASDAS).

  Baseline and Week 12

• Percentage of Patients Who Achieved ASAS 5/6 Improvement Criteria at Week 12

  Week 12

• Percentage of Patients Who Achieved Partial Remission According to the ASAS Criteria at Week 12

  Week 12

• Percentage of Patients Who Achieved ASAS 20 Improvement Criteria at Week 12

  Week 12

• Change From Baseline to Week 12 in Disease Activity Assessed by BASDAI

  Baseline and Week 12

Study Arms (4)

Placebo

PLACEBO COMPARATOR

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.

Drug: placebo for risankizumab

Risankizumab 18 mg

EXPERIMENTAL

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

Drug: risankizumab

Risankizumab 90 mg

EXPERIMENTAL

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

Drug: risankizumab

Risankizumab 180 mg

EXPERIMENTAL

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

Drug: risankizumab

Interventions

placebo for risankizumab DRUG

Placebo for risankizumab administered by subcutaneous (SC) injection

Placebo

risankizumab DRUG

Risankizumab administered by subcutaneous (SC) injection

Also known as: ABBV-066, BI 655066, SKYRIZI

Risankizumab 18 mg; Risankizumab 180 mg; Risankizumab 90 mg

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)
• 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.

Sponsors & Collaborators

• AbbVie: lead
• Boehringer Ingelheim: collaborator

Related Publications (1)

• Baeten D, Ostergaard M, Wei JC, Sieper J, Jarvinen P, Tam LS, Salvarani C, Kim TH, Solinger A, Datsenko Y, Pamulapati C, Visvanathan S, Hall DB, Aslanyan S, Scholl P, Padula SJ. Risankizumab, an IL-23 inhibitor, for ankylosing spondylitis: results of a randomised, double-blind, placebo-controlled, proof-of-concept, dose-finding phase 2 study. Ann Rheum Dis. 2018 Sep;77(9):1295-1302. doi: 10.1136/annrheumdis-2018-213328. Epub 2018 Jun 26.

  PMID: 29945918 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Spondylitis, Ankylosing

Interventions

risankizumab

Condition Hierarchy (Ancestors)

Axial Spondyloarthritis; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Ankylosis; Joint Diseases; Arthritis

Limitations and Caveats

The hierarchical testing p-values are exploratory in nature, due to the study design, as the primary endpoint of study failed to meet the desired objective.

Results Point of Contact

• Title: Global Medical Services
• Organization: AbbVie

abbvieclinicaltrials@abbvie.com

800-633-9110

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2014
• First Posted: January 28, 2014
• Study Start: January 28, 2014
• Primary Completion: March 5, 2015
• Study Completion: July 25, 2016
• Last Updated: May 31, 2019
• Results First Posted: May 31, 2019

Record last verified: 2019-05