THERAPEUTIC USE OF TADEKINIG ALFA IN ADULT-ONSET STILL’S DISEASE

Phase 1

• Conditions: Therapeutic area: Diseases [C] - Immune System Diseases [C20]; Adult -onset Still’s Disease (AoSD); MedDRA version: 18.1Level: PTClassification code 10064056Term: Still's disease adult onsetSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

• Registration Number: EUCTR2014-002500-24-DE
• Lead Sponsor: AB2 Bio Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-10-08
• Last Update Posted: 10 July 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Patients aged 18 years and older, diagnosed as AoSD based on the presence of the Yamaguchi criteria with active disease, irrespective of the continuation of the permitted treatment mentioned below

Patients with active disease will be considered if they exhibit at least two of the Yamaguchi’s major criteria at the screening visit plus at least either fever or elevation of markers of inflammation (CRP = 10 mg/L).

Patients that have been exposed to NSAIDS, Prednisone (at least 5 mg/day) for = 1 month) and/or synthetic sDMARDs (methotrexate at a dose of at least 10mg/week) for = 3 months without response to treatment or with incomplete response to treatment

Women of childbearing potential with negative pregnancy test at screening, V3, V4, V5 and V6 and that agree to follow highly effective birth control recommendations during the study and until 1 month after the end of the treatment. Birth control methods that are considered as highly effective are either: combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation, progestogen-only hormonal contraception associated with inhibition of ovulation, intrauterine device (IUD), intrauterine hormone-releasing system (IUS), bilateral tubal occlusion, vasectomized partner or sexual abstinence.
In each case of delayed menstrual period (over one month between menstruations, confirmation of absence of pregnancy is strongly recommended. This recommendation also applies to women of child bearing potential with infrequent or irregular menstrual cycles.
As regards the duration of contraception after the study, taking into account the median half-life of Tadekinig alfa of almost 40h, 5 half-lives represent duration of 200 hours. In order to be on the safe side, a post-study contraception duration of 4 weeks is recommended

Patients can maintain treatment with stable doses of Non-Steroidal anti-inflammatory Drugs (NSAIDs), Prednisone (stable dose of Prednisone (of at least 5 mg/day), and sDMARDs during Tadekinig alfa treatment (methotrexate at a dose of at least 10mg/week). Specifically baseline levels of prednisone treatment can be maintained or tapered (due to patient improvement), any requirement for prednisone increase during treatment will be considered a treatment failure.

Ability to understand and willingness to sign a written informed consent

Previous treatments with biologicals are allowed if the following wash-out periods are respected: one week for anakinra, two weeks for etanercept, and 6 weeks for adalimumab, certolizumab, golimumab, tocilizumab, abatacept and 8 weeks for infliximab. Previous rituximab administration will require 6 months of washout and normal B-cell counts and previous treatment with canakinumab will require 6 months of washout.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 18
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 2

Exclusion Criteria

Patients with a first episode of AoSD with less than one month of therapy with Prednisone or sDMARDs

Patients with active or chronic infections (i.e. Tuberculosis (TB), HIV, HBV & HCV)

Patients suffering from inherited immunodeficiency diseases

Patients suffering from immune-mediated inflammatory diseases, including autoimmune diseases such as RA, SLE, etc., or spondylarthropathies, or inflammatory bowel disease.

Patients with white blood cell counts below 2’500 cells/mm3

Patients with Neutrophils below 1’000 cells/mm3

Concomitantly treated with biologicals

Women of childbearing potential who are unwilling to use highly effective birth control methods (see definition in Inclusion criteria above) up to 1 month after the end of her participation in the study.

Inability to understand and unwilling to sign a written informed consent

Active Macrophage Activation Syndrome (MAS)

Any acute or chronic life-threatening disease: such as cancer, and irreversible organ failures of heart, liver, lung and kidney (creatinine not higher than 1.5 X upper limit of normal)

Patients having received adalimumab, certolizumab, golimumab, tocilizumab and abatacept within 6 weeks, infliximab within 8 weeks, canakinumab within 6 months, etanercept within 2 weeks, or anakinra 1 week prior to the start of Tadekinig alfa will not be enrolled into the study. Patients that have received rituximab within 6 months and/or have persistent low B-cell counts will not be eligible for enrolment.

Subject who cannot be expected to comply with the study procedures

Currently participating or having participated in another clinical trial during the last 4 weeks prior to the beginning of this study.

Patients with no social security coverage

Patients with a history of severe hypersensitivity reactions

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified