We are conducting a clinical trial for a potential new medicine that could be used to treat people with Pemphigus Vulgaris (PV).
In this study, we are asking patients diagnosed with PV aged 18 to 70 years to test the new medicine so we can see how well tolerated the medicine is and how long it stays in your body.
Clinical study summary
The aim of this trial is to determine how safe and well-tolerated the investigational medicine TPM203 is when given to patients diagnosed with PV.
The trial will also assess how long the investigational medicine remains in the blood and how it affects the body.
This trial will involve you staying with us for a few days (see below) at our private medical facility in London Bridge.
You will be given the study treatment which (if the study drug works as expected) should reduce the white blood cell responses which are associated with the disease which should reduce the symptoms of PV.
- You will need to attend a screening appointment so we can check if you are suitable to take part in the trial. At this appointment we will perform a number of tests including taking blood samples, checking your heart, and carrying out a physical examination to see if it will be OK for you to take part in the study.
- If the results from your screening appointment show you are a good candidate for the trial, you will be invited to take part.
- This will involve a stay of 3 days and 2 nights in our research unit.
- The new medicine will be given to you once by intravenous infusion (this means that the drug will be administered into the veins through a needle or plastic catheter).
- After your stay with us, for Part B of the study, you will be required to return for 9 follow-up visits on Weeks 1, 2,3, 4, 5,6, 8, 12, and 16 of the study.
- This means the whole process takes approximately 16 weeks from your screening visit through to your final visit.
- In total, if you are included in the study you will come to the research unit 10 times.
On days you are not required to attend the unit, a text messaging system will be used to conduct a check-up assessment until your next visit to the unit.
Who can take part?
We will check your suitability for the clinical trial using the following criteria:-
- You are a male or female aged between 18 to 70 years.
- If You have a bodyweight of ≥50 kg and a body mass index ≥18.5 and ≤32 kg/m2.
- You are diagnosed with Pemphigus Vulgaris (PV) based on the following (all documented):
- Clinical features, i.e. blisters and/or erosions of the skin and/or mucous membranes, and
- Direct immunofluorescence microscopy of skin/mucosa, and
- Serum IgG against Dsg3 by ELISA.
- Your symptoms have gone away (complete clinical remission) or have greatly improved (you have low to moderate clinical disease activity (i.e. ABSIS ≤17 and PDAI ≤15).)
- You have anti-Dsg3 antibodies (IgG) in blood samples taken at the screening visit.
- You have the peripheral blood CD4+ T cells specific for at least one of the Dsg3 peptides employed by functional or phenotypic assays in blood samples taken at the screening visit.
- You must have no other underlying medical conditions that may affect the trial or put you at any significant risk. If a chronic illness (e.g. hypertension) is present, it is stable and well-controlled, and it is not considered by the investigator to interfere with the primary objectives of the study.
- You must show a negative result in a pregnancy test.
- If you are sexually active, you must be willing to use appropriate contraception, starting from the first day of dosing until 3 months later.
- You must be a non-smoker/non-user of nicotine or a light smoker/user of nicotine (defined as ≤10 cigarettes per day).
- You must not test positive for alcohol or drugs or show any evidence of drug or alcohol abuse (Alcohol abuse is defined as a regular weekly intake of more than 14 units).
- You must not have a tattoo or body piercing that might interfere with the injection site examination throughout the clinical trial.
- You must not have any abnormal findings that could make your skin unsuitable for biopsy (a sample of tissue taken from the body) including tattoos, scars, acne, burn, or underlying skin condition.
- You must not have any known wound healing disorders such as keloids (a thick, lumpy, raised scar that grows past the wound and into the surrounding skin), hypertrophic scarring (a thick, raised scar which is a natural response to wound healing), or delayed wound healing.
A full list of do’s and don’ts will be given to you by a member of our recruitment team if you are interested and want to find out more.
Clinical trial payment
In recognition of the time involved in taking part in this trial, you will receive £1,524 (£1,015 trial payment and £509 compliance bonus) on completion of the trial provided you comply fully with all the trial requirements. This amount is based on the anticipated trial plan and will be adjusted pro-rata (i.e. same amount of money paid per unit of time), should we invite you to attend extra visits.
Clinical trial dates
For further details on trial dates, please contact a member of the recruitment team on 020 7042 5800 (select option 1) or register to receive a call.
You may be required to remain resident in the unit until the resolution of any safety issues, after which you will be discharged from the unit.
The contents of this page have been approved by an ethics committee. Any response to this advertisement will be recorded. Your response will not place you under any obligation to participate in this trial.