A Clinical study to investigate if rVA576 is safe and has an effect on patients who have mild or moderate Bullous Pemphigoid (a blistering disorder where the skin forms tense blisters)
- Conditions
- Mild to Moderate Bullous PemphigoidMedDRA version: 21.1Level: LLTClassification code 10006567Term: Bullous pemphigoidSystem Organ Class: 100000004858Therapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- EUCTR2017-002836-18-NL
- Lead Sponsor
- Akari Therapeutics Plc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 9
1.Adult male or female =18 -old patients
2.Subject with newly presenting mild to moderate BP not on any current systemic corticosteroid or immunomodulator treatment. (Subjects on topical corticosteroids will stop use of these on or before Day1)
3.BPDAI global score at Screening of 10-56 (= 10 but <56)
4.Subjects with a relapse of mild to moderate BP are eligible if their disease was quiescent without any systemic treatment for at least 2 months before the current relapse.
5.Cutaneous BP per standard diagnostic criteria:
a.Clinical presentation (cutaneous blistering and/or itchy dermatosis),
AND
b.Direct immunofluorescence (DIF) studies performed on erythematous perilesional skin collected approximately 1 cm away from a fresh blister, an erosion or papule showing linear (n-serrated) deposition of IgG and/or C3 along the epidermal basement membrane zone,
AND/OR
Indirect immunofluorescence (IIF) studies performed with patient serum on 1.0M NaCl human salt split skin, showing IgG along the roof of the blister.
6.Karnofsky performance status > 60%
7.Adequate cardiac, pulmonary, renal, hepatic, neurological and psychiatric function as determined by the Investigator and demonstrated by screening laboratory evaluations, vital sign measurement, ECG recording and physical examination results.
8.Woman of childbearing potential (WOCBP) must agree to use effective contraception consistently throughout the study and have a negative serum pregnancy test at screening and a negative urine pregnancy test per the schedule of visits. Women are considered post-menopausal and not of childbearing potential if they have had 12 months of amenorrhea or have had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least six weeks previously.
9.Males with a childbearing potential partner of must agree to use effective contraception consistently OR have had a vasectomy
10.Willing and able to adhere to the study visit schedule and other protocol requirements including self-injection.
11.Willing and able to provide voluntary written informed consent.
12.Willing to receive immunisation against Neisseria meningitidis and antibiotic prophylaxis in accordance with the applicable guidelines and local standard of care of the PI at the trial site
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 2
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 7
Disease related (BP) Exclusion criteria
1.Patients with severe BP where severe disease is defined as global BPDAI = 56.
2.Patients with refractory BP. Refractory BP may be defined as failure or loss of response to maximal doses of topical or oral steroids.
3. Suspected drug induced BP.
4.Concomitant skin conditions preventing physical evaluation of BP.
rVA576 and Mometasone related exclusion criteria
5.Participation in a clinical trial of an investigational product within 6 weeks of screening.
6.Known hypersensitivity to tick or to rVA576 and any of its excipients.
7.BP patients on systemic corticosteroid or systemic immunomodulator treatment (including azathioprine, dapsone, rituximab etc).
8.Treatment with any biologics (e.g. etanercept, adalimumab, ustekinumab, infliximab, intravenous immunoglobulins (IVIG) and rituximab or other anti-CD20 therapies) within its 5 half-lives from screening.
9.Known hypersensitivity to mometasone furoate or to other corticosteroids or to any of the excipients in mometasone furoate
10.Received rVA576 or any other recognised systemic medications for the treatment of the current episode of BP prior to study entry. Prior topical treatment with corticosteroids is permitted. This must be discontinued and study medications started on Day 1
General Exclusion Criteria
11.Patients with severe medical or surgical conditions at screening or baseline including, but not limited to cardiac, respiratory, renal, hepatic haematological, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, cerebral, psychiatric, or any other severe acute or chronic medical condition that may increase the risk associated with study participation/treatment or may interfere with the interpretation of study results and, in the Investigator's opinion, would make the patient inappropriate for study entry.
12.Presence of any malignancy that has been under active treatment or in previous 5 years with the exception of patients with removal of uncomplicated basal cell carcinoma or cutaneous squamous cell carcinoma, who may take part in the study.
13.Congenital or acquired immunodeficiency (e.g. common variable immunodeficiency, organ transplantation).
14.Clinically significant vital sign measurements or ECG findings as determined by the Investigator.
15.Clinically significant abnormal laboratory test results including but not limited to:
•Haemoglobin level <10.0 g/dL
•White blood cell count < 3 x 103/µL
•Lymphocyte count < 0.5 x 103/µL
•Platelet count <100 x 10*9 /L or >1200 x 10*9/L
•Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3 x the upper limit of normal (ULN)
•Alkaline phosphatase >3 x ULN
•Serum creatinine >2 x ULN
16.Active or recent history of clinically significant infection within 1 month of screening.
17.Pregnant or breast-feeding, or planning to become pregnant during the study.
18.Evidence of an active disease of hepatitis B (HBsAg positive or HBcAb positive) or hepatitis C (HCV ab positive), CMV (IgM positive) or human immunodeficiency virus (HIV) infection (HIV1/2 Ab positive
19.Active abuse of alcohol or drugs.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method