This study is looking at a potential new treatment, secukinumab for patients diagnosed with non-ocular Behçet's Syndrome. Phase II wants to evaluate how safe and how effective secukinumab might be. Patients will be assigned to either the study drug (secukinumab) or placebo arm for 16 weeks, followed by 36 weeks of treatment for both groups. Double blind trial means that neither the patient nor the study team will be able to tell which arm the patient is allocated to.
- Conditions
- Behçet's syndromeCirculatory System
- Registration Number
- ISRCTN94958652
- Lead Sponsor
- Royal Liverpool and Broadgreen University Hospital NHS Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 64
1. Patient must be able to understand and communicate with the investigator and comply with the requirements of the study and must give a written, signed and dated informed consent before any study assessment is performed
2. Male or non-pregnant, non-lactating female patients at least 18 years of age
3. Diagnosis of Behçet's Syndrome as defined by the 1990 International Study Group (ISG) and who have failed to respond to at least first line treatment with topical steroid (mouth wash or skin cream) and colchicine (= 500microg twice/day), azathioprine (=2.5 mg/kg/day), or a single TNFa inhibitor (if due to inefficacy, after a trial of 3 months. If due to intolerance, at any stage).
4. Patients must have either signs of skin manifestations (including papulopustular lesions, erythema nodusum or vasculitis), mucosal ulceration, and/or joint tenderness that the investigator considers to be caused by active BS at randomization.
5. At least one active oral ulcer is required
6. Failure to respond to first line therapy with topical steroid (mouth wash or skin cream), colchicine (= 500microg twice/day) or azathioprine (=2.5 mg/kg/day).
7. Patients taking corticosteroids must be on a stable dose of no more than 5 mg/day prednisone or equivalent for at least 2 weeks before randomization and can continue this during the study
8. Patients taking azathioprine (=2.5 mg/kg/day) are allowed to continue their medication if the dose is stable for at least 4 weeks before randomization.
9. Patients taking topical steroid (as mouth wash or skin cream) can continue with this medication as required.
10. Patients taking colchicine must be on a stable dose (=500mcg twice/day) for at least two weeks before randomization and can continue with this medication.
11. Prior exposure to a maximum of one TNFa inhibitor is permitted if due to TNFi inefficacy (after a trial of 3 months) or if due to intolerance (at any stage).
1. History of Behçet's related active central nervous system, peripheral nervous system, vascular disease, gastrointestinal system, or inflammatory ocular disease requiring systemic therapy over the preceding 12 months.
2. If there is chest X-ray or chest MRI with evidence of ongoing infectious or malignant process, obtained within 3 months prior to screening and evaluated by a qualified physician.
3. Patients taking high potency opioid analgesics (e.g. methadone, hydromorphone, morphine)
4. Previous exposure to secukinumab or other biologic drug directly targeting IL-17 or IL-17 receptor
5. Use of any investigational drug and/or devices within 4 weeks before randomization or a period of 5 half-lives of the investigational drug, whichever is longer
6. History of hypersensitivity to the study drug or its excipient or to drugs of similar chemical classes.
7. Any intramuscular or intravenous corticosteroid treatment within 4 weeks before randomization
8. Any therapy by intra-articular injections (e.g. corticosteroid) within 4 weeks before randomization
9. Patients who have previously been treated with more than 3 different TNF-a inhibitors (investigational or approved)
10. Patients who have ever received biologic immunomodulating agents except for those targeting TNFa, investigational or approved
11. Previous treatment with any cell-depleting therapies including but not limited to anti-CD20, investigational agents (e.g., CAMPATH, anti-CD4, anti-CD5, anti-CD3, anti-CD19)
12. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive urine pregnancy test
13. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unwilling to use effective contraception during the study and for 16 weeks after stopping treatment. Effective contraception is defined as either: a. Barrier method: Condom or Occlusive cap (diaphragm or cervical/vault caps) with spermicide (where available). Spermicides alone are not a barrier method of contraception and should not be used alone
The following methods are considered more effective than the barrier method and are also acceptable:
13.1. Total abstinence: When this is in line with the preferred and usual lifestyle of the patient [Periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception]
13.2. Female sterilization: have had a surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least six weeks before taking study treatment. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment
13.3. Use of established oral, injected or implanted hormonal methods of contraception, intrauterine device (IUD) or intrauterine system (IUS). In case of use of oral contraception women should have been stabile on the same pill for a minimum of 12 weeks before taking study treatment.
NOTE: Women are considered post-menopausal and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or six months of spontaneous amenorrhea as defined by the Central Lab FSH and/or oestradiol levels
14. Active ongoing inflammatory diseases other than Behçet's syndrome that might confoun
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Change from baseline in Behçet's oral ulcer severity score at 16 weeks. (An improvement of 20% is considered to be clinically meaningful). The USS incorporates six ulcer characteristics: number, size, duration, ulcer-free period, site, and pain. It is scored by the clinician, based on patient reported details. There is a continuous scale between 0 (no problems) to 84 (most severe problems).
- Secondary Outcome Measures
Name Time Method 1. Change from baseline in Disease Activity as Measured by (BDCAF) at week 16 and week 52 end of study <br>2. Change from baseline in patient's perception of disease, as measured by BDCAF: patient's perception of disease activity at weeks 16 and 52<br>3. Change from baseline in Disease Activity as Measured by BDCAF: Clinician's Overall Perception of Disease Activity at Week 16 and 52