All relevant information on the start of the Phase II trial
On March 7, 2018, MetrioPharm announced “First Patient First Dose” for its ongoing Phase II clinical trial, a “multi-center, double-blind, placebo-controlled, clinical trial in the indication psoriasis.”
For our blog, we have collected the keywords from this press release and explain what they mean in concrete terms for MetrioPharm and our ongoing trial.
Phase II trial
A medical substance must undergo a series of test phases before it can be approved as a drug. In the ongoing clinical phase II trial, three key questions will be answered:
Is MetrioPharm’s compound MP1032 safe? To date, MP1032 has shown that it does not have any significant negative effect (Serious Adverse Event) on healthy volunteers (Phase I) and patients (Phase IIa). These good results are now to be confirmed in therapeutic use over a longer period of time.
Is MP1032 effective? In the second clinical phase, MP1032 is evaluated for its therapeutic effect in a larger number of patients and for a longer period of time. The indication selected for this treatment is psoriasis.
How to dose MP1032? MetrioPharm has already shown in an exploratory Phase IIa trial that MP1032 has a positive effect treating psoriasis. While the Proof of Concept has been achieved, different dosages and their effect on patients must now be investigated for therapeutic application.
First Patient First Dose
When does a clinical trial officially start? At the time of its conception, after its approval by the authorities or upon first contact between doctor and patient? All these common steps lead into a clinical trial. Still the first treatment appointment of the first patient (First Patient First Dose) is regarded as the most important milestone.
Although the investigator and the patient have already met before this appointment for a so-called screening: an examination that ensures that the patient meets all the necessary requirements as a study participant. In addition, the patient is briefed on the clinical trial and consents to participate.
However, the actual inclusion in the trial will not take place until the next appointment. During this visit, the baseline data are measured, i. e. the severity of a patient’s psoriasis prior to the start of the trial. Then the patient receives a study diary. From now on, he has to monitor every intake of the preparation. Finally, he receives the investigational drug. The treatment phase has begun.
Design of the trial
Up to 150 patients aged between 18 and 70 years will participate in this trial. The subjects are male and female patients with moderate-to-severe chronic plaque psoriasis. The clinical trial is expected to be conducted in 14 trial sites in Germany and Poland.
It is a three-arm trial: two different doses of MP1032 are tested in direct comparison to a placebo. Test patients receive either 150 mg MP1032 twice daily or 300 mg MP1032 twice daily or a placebo twice daily.
Duration of the trial
The duration of the trial cannot yet be determined exactly at the time of First Patient First Dose. The approximately 150 patients do not enter the trial simultaneously.
Participation per patient can last up to 20 weeks: 4 weeks wash out of previously taken medication, 12 weeks treatment, 4 weeks follow-up. During this time, the volunteers come to the trial centre for six visits. Even if the first patients have already completed the trial, new participants can still be included.
Inclusion in the trial is competitive: Patients are enrolled in several trial sites in parallel. Only when the target number of participants has been reached will the recording activities be ended.
Even after inclusion of the last patient, it therefore takes a maximum of 20 weeks to complete the data collection. This is then followed by data evaluation and unblinding.