| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
| Psoriasis of the fingernail |
|
| MedDRA Classification |
| E.1.3 | Condition being studied is a rare disease | No |
| E.2 Objective of the trial |
| E.2.1 | Main objective of the trial |
1. Evaluate improvements in the appearance of the target fingernail, utilizing photography for imaging and independent photograph evaluators.
2. Assess safety, i.e., the frequency and severity of adverse events associated with MQX-5902, MQX-5904 and MQX-5906 in the treatment of patients with fingernail
psoriasis. |
|
| E.2.2 | Secondary objectives of the trial |
Secondary endpoints include improvement in:
- Appearance of the control fingernail as determined by independent evaluators,
- The target fingernail as measured by the investigator using the mNAPSI (a modification of the Nail Psoriasis Severity Index),
- Comparison of improvement of the mNAPSI of the target and control fingernails.
Information on relative changes in nail psoriasis severity of the other affected fingernails will be collected. Comparison of nail growth of the target & control fingernails as determined from nail notch movement measured on nail photographs will be performed.
Safety will be evaluated by type & frequency of adverse events and relatedness to active agent.
Methotrexate blood levels will be used to evaluate the potential for methotrexate toxicity |
|
| E.2.3 | Trial contains a sub-study | No |
| E.3 | Principal inclusion criteria |
1. Outpatients, 18 years to 75 years of age, of any race and of either sex.
2. Patients must be in good general health, as assessed by the clinical study investigator.
3. Patients must present with clinically diagnosed stable or exacerbating fingernail psoriasis of at least two fingernails (one of which is chosen as the “target nail” and one of which is chosen as the “control nail”), at the Screening Visit. The patient must have a diagnosis of psoriasis in any area but not palms and soles only.
4. Patients must have moderate, not mild or severe, nail psoriasis of at least 2 fingernails. This evaluation is based on standard reference photographs provided by the sponsor that denote the range of nail psoriasis severity termed moderate for this study.
5. Patients must sign a statement of informed consent.
6. Patients must be able to understand the requirements of the study, abide by the
restrictions, apply the study medication as instructed, and return for all of the required clinic visits.
7. Female patients must be post-menopausal for at least five years, or have had a
hysterectomy, or have had a tubal ligation, or agree to use oral/systemic contraceptives or an intrauterine device (IUD) starting at least 28 days Visit 1, or agree to use a spermicide in combination with barrier methods of contraception. Male patients must agree to use a spermicide in combination with barrier methods of contraception. Contraceptive methods must be continued throughout the study and for at least 3 months after treatment has finished.
8. Female patients who are not at least 5 years post-menopausal or surgically sterile must have had a normal menstrual flow within approximately one month prior to Visit 1, and have a negative urine pregnancy test within 7 days prior to Visit 1. Results must be available prior to the first application of test medication. Note: urine pregnancy tests must be performed at each clinic visit.
(Note: urine pregnancy tests must be performed at each clinic visit.)
9. Patients’ psoriasis therapies must have been stable and unchanged for 2 months prior to the screening visit. Patients must not have received methotrexate for 3 months prior to the screening visit. Patients must agree to apply any non-study topical psoriasis medications used during the course of the study while wearing vinyl gloves and to not apply any of these topical medications to the distal phalanx. |
|
| E.4 | Principal exclusion criteria |
1. Patients with fingernail infections of fungal or bacterial origin, by clinical impression (microbiological confirmation not required).
2. Patients for whom the target or control fingernail is thicker than 2 mm.
3. Patients with other abnormalities of the target fingernail that could prevent obtaining a normal appearing nail if clearing of psoriasis is achieved (i.e., chemical damage, tumors, genetic disorders affecting the nail, pigmentation disorders).
4. Patients with any disease/condition that might cause nail abnormalities or might interfere with the evaluation of the test materials (i.e., open sores on the affected finger, a history of nail biting, nail infections, lichen planus, peripheral vascular disease, and traumatic onychodystrophy due to chronic physical stimuli).
5. Patients who have a history of immunosuppression and/or clinical signs indicative of possible immunsuppression, according to the clinical investigator.
6. Patients with neuropathies of the hand
7. Patients who have screening laboratory values which are 20% or greater of the upper or lower limit of normal if they are considered by the investigator to be clinically significant or indicative of conditions that might complicate interpretation of study results.
8. Patients who are nursing, who are pregnant (confirmation by pregnancy testing) or who plan to become pregnant or father a child within the study time frame, including within three months of last scheduled dose of study medication.
9. Patients known to be HIV positive (HIV testing is not required).
10. Patients who have abused alcohol or drugs in the 12 months prior to screening or who currently are known to abuse alcohol or drugs.
11. Patients with known hypersensitivity to any components of the test materials.
12. Patients requiring or using other methotrexate preparations (by any route), or non-study topical anti-psoriatic medications to the distal phalanx, or ultraviolet treatment within 2 months of commencement of study treatment (Visit 1).
13. Patients who have used more than one 2-week course of oral corticosteroid therapy or one intramuscular corticosteroid injection during the three months prior to the screening visit.
14. Patients who use manicures, any nail polish products or other nail cosmetic products on the target or control fingernail within 7 days prior to the start of treatment. (Patients must agree not to use manicures, nail polish or nail cosmetic products during the study.)
15. Patient who have received any investigational drugs or devices or who have participated in any investigational drug/device study within 28 days prior to the start of treatment.
16. Patients who require or have had within 90 days of the start of treatment any drug known
to have a well-defined potential for toxicity to a major organ (i.e., chloramphenicol).
17. Patients with a history of poor cooperation, non-compliance with medical treatment, or unreliability.
(Note: In determining the length of washout, the last day therapy was used
should be counted as Day 0.) |
|
| E.5 End points |
| E.5.1 | Primary end point(s) |
The primary efficacy endpoint of MQX-5902, MQX-5904 and MQX-5906 will be assessed in terms of changes in the target fingernail between Study Visit 1 and Study Visit 4 as assessed by independent photograph evaluators. The three doses will be compared with each other.
Secondary endpoints will include:
• The determination of changes of the control fingernail as determined by independent evaluators,
• The improvement of the target fingernail as measured by the investigator using the mNAPSI,
• The comparison of the improvement of the mNAPSI of the target and control fingernails.
The comparison of nail growth of the target and control fingernails as determined from nail notch movement measured on nail photographs taken at screening and Visits 1, 2, 3, and 4 and the follow-up visit will be performed.
The safety of MQX-5902, MQX-5904 and MQX-5906 will be assessed from the frequency and severity of adverse events as reported by the patient to the clinic personnel, by comparison of the blood levels of methotrexate in the different doses and any associated changes in CBC, differential and clinical chemistry profile with liver function tests (SGOT, SGPT, and GGT) and Urinalysis. |
|
| E.6 and E.7 Scope of the trial |
| E.6 | Scope of the trial |
| E.6.1 | Diagnosis | No |
| E.6.2 | Prophylaxis | No |
| E.6.3 | Therapy | Yes |
| E.6.4 | Safety | Yes |
| E.6.5 | Efficacy | Yes |
| E.6.6 | Pharmacokinetic | No |
| E.6.7 | Pharmacodynamic | No |
| E.6.8 | Bioequivalence | No |
| E.6.9 | Dose response | Yes |
| E.6.10 | Pharmacogenetic | No |
| E.6.11 | Pharmacogenomic | No |
| E.6.12 | Pharmacoeconomic | No |
| E.6.13 | Others | No |
| E.7 | Trial type and phase |
| E.7.1 | Human pharmacology (Phase I) | No |
| E.7.1.1 | First administration to humans | No |
| E.7.1.2 | Bioequivalence study | No |
| E.7.1.3 | Other | No |
| E.7.1.3.1 | Other trial type description | |
| E.7.2 | Therapeutic exploratory (Phase II) | Yes |
| E.7.3 | Therapeutic confirmatory (Phase III) | No |
| E.7.4 | Therapeutic use (Phase IV) | No |
| E.8 Design of the trial |
| E.8.1 | Controlled | Yes |
| E.8.1.1 | Randomised | Yes |
| E.8.1.2 | Open | No |
| E.8.1.3 | Single blind | No |
| E.8.1.4 | Double blind | Yes |
| E.8.1.5 | Parallel group | Yes |
| E.8.1.6 | Cross over | No |
| E.8.1.7 | Other | No |
| E.8.2 | Comparator of controlled trial |
| E.8.2.1 | Other medicinal product(s) | No |
| E.8.2.2 | Placebo | No |
| E.8.2.3 | Other | Yes |
| E.8.2.3.1 | Comparator description |
| An untreated "Control Fingernail" will be used |
|
| E.8.3 |
The trial involves single site in the Member State concerned
| No |
| E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
| E.8.4.1 | Number of sites anticipated in Member State concerned | 7 |
| E.8.5 | The trial involves multiple Member States | No |
| E.8.5.1 | Number of sites anticipated in the EEA | 7 |
| E.8.6 Trial involving sites outside the EEA |
| E.8.6.1 | Trial being conducted both within and outside the EEA | No |
| E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
| E.8.7 | Trial has a data monitoring committee | Yes |
| E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
| The end of the trial will be the last visit of the last patient as defined in the Trial Protocol. |
|
| E.8.9 Initial estimate of the duration of the trial |
| E.8.9.1 | In the Member State concerned years | 1 |
| E.8.9.1 | In the Member State concerned months | 0 |
| E.8.9.1 | In the Member State concerned days | 0 |
| E.8.9.2 | In all countries concerned by the trial years | 1 |
| E.8.9.2 | In all countries concerned by the trial months | 0 |
| E.8.9.2 | In all countries concerned by the trial days | 0 |
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