Clinical trial NCT03706209 (phase 2, status: completed)
Conditions: psoriasis
ICD codes: L40.0, L40.4, L40.8, L40.9, L40.1, L40.50
Drugs: mp1032, placebo
SMILES: CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
Eligibility criteria:

        Inclusion Criteria:

          1. Participants legally competent to sign and give informed consent.

          2. Adult male and female patients between 18 years and 70 years with moderate-to-severe
             chronic plaque psoriasis (diagnosed by Investigator):

               1. PASI score ≥10 - ≤20 at baseline

               2. BSA score: > 10%

               3. Stable disease duration of ≥ 6 months at the initiation of IMP.

               4. topical therapy fails to control the disease

          3. Body Mass Index (BMI) between 18.5 and 34.9 kg/m2.

          4. Women of childbearing potential (WCBP) must have a negative serum pregnancy test at
             Screening (Visit 1). In addition, sexually active WCBP must agree to use adequate
             contraception throughout the trial (see Section 3.2 for more details on adequate
             contraception):

               1. A method with less than 1% failure rate OR

               2. Abstinence

          5. Post-menopausal women with spontaneous amenorrhea for at least 12 months and women on
             hormonal replacement therapy (HRT). The use of hormonal replacement therapy (HRT)
             during the trial is permitted, however for these patients an appropriate contraception
             method according to Inclusion Criterion 4 must be ensured. Sterilized women may be
             included (see Section 3.2 for more details on sterile definition)

          6. Male patients who are sexually active with a female partner and are not surgically
             sterile (vasectomy performed at least six months prior to treatment) must agree to
             inform their female sexual partner to use an acceptable form of birth control as
             described in the informed consent form. For females, an acceptable method (Pearl Index
             < 1%) would be to use implants, injectable, combined oral contraceptives, some
             intrauterine devices, or be postmenopausal, be surgically sterile (hysterectomy,
             bilateral tubal ligation, or bilateral oophorectomy)

          7. In good health as judged by the investigator, based on medical history, physical
             examination, serum chemistry, hematology and urinalysis

          8. Patients must meet the following clinical laboratory criteria:

               -  White blood cell count ≥3.5 × 109/L

               -  Platelet count ≥100 × 109/L

               -  Serum creatinine ≤1.5 × upper limit of normal (ULN); estimated glomerular
                  filtration rate >60 mL/min

               -  Total bilirubin ≤1.5 × ULN

               -  Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 × ULN

               -  Hemoglobin ≥ lower limit of normal as per central laboratory reference ranges for
                  women and men accordingly

               -  No coagulopathy (International Normalized Ratio [INR] <1.5)

          9. Patients agree to minimize normal sun exposure during the course of the trial

         10. Patients are considered reliable and capable of adhering to the protocol (e.g. able to
             understand the patient information and complete diaries), visit schedule, or
             medication intake according to the judgment of the Investigator.

        Exclusion Criteria:

          1. Patients with non-plaque form of psoriasis (erythrodermic, guttate, pustular form of
             psoriasis). Associated psoriasis arthritis is allowed provided no other in-/exclusion
             criteria are influenced, no forbidden concomitant therapy is required for the well
             -being of the patient and there is no impact on trial objectives as determined by the
             Investigator.

          2. Treatment with concomitant medication that may affect and provoke or aggravate
             psoriasis, e.g. antimalarial drugs, beta-blockers or ACE
             (angiotensin-converting-enzyme) inhibitors unless on a stable dose for 3 months before
             IMP intake.

          3. Evidence of skin conditions at the time of Screening Visit other than psoriasis that
             would interfere with evaluations of the effect of the IMP on psoriasis.

          4. Patients with any serious medical condition, laboratory abnormality, or psychiatric
             illness that would prevent the patient from signing the ICF, as assessed by the
             investigator.

          5. Pregnant or lactating women or women planning to become pregnant during the trial and
             / or within 28 days following the last dose of IMP.

          6. Male patients planning a partner pregnancy or sperm donation during the trial
             including follow up period.

          7. Known allergies to any ingredient of the IMP e.g. mannitol, macrophage modulators, or
             gelatin.

          8. History or symptoms of a clinically significant illness in the four weeks before first
             treatment and during the trial that in the opinion of the investigator may place the
             patient at risk by trial participation or influence the outcome of the trial. Well
             controlled diseases such as hypertension, hyperlipidemia, diabetes or hypothyroidism
             are permitted.

          9. Patients with active malignancy or history of malignancy, except for basal cell and
             actinic keratosis. Basal cell carcinoma of the skin or in situ cervical carcinoma that
             have been fully treated and show no evidence of recurrence are allowed.

         10. Positive HIV-Antibody, HBs-Antigen or HCV-Antibody-Test at screening.

         11. Previous strong sun exposure (e.g. sea holiday) within 28 days or UV treatment within
             24 weeks before IMP initiation.

         12. Known photo allergy and / or experienced drug-induced photo toxicity.

         13. Elective (planned) hospitalization or medical intervention preventing patient from
             following the protocol requirements.

         14. Prior treatment not adhering to defined drug classes and related washout periods
             (Protocol table 2.)

         15. Planned use of any ultraviolet (UV) phototherapy or photochemotherapy /
             photosensitizing drugs during the course of the trial and within 28 days/24 weeks
             following the last dose of the IMP.

         16. Patients with a history of chronic alcohol or drug abuse within 6 months of IMP
             initiation.

         17. Patients with a blood pressure outside the given range of 160 mm Hg (systolic) and 95
             mm Hg (diastolic)

         18. Patients who are employed by MetrioPharm, contract research organization (CRO) or
             clinical site involved in the clinical trial.

         19. Vulnerable patients (e.g. patients kept in detention).

         20. Patients who are unable to communicate, read or understand the local language, or who
             display another condition, which, in the Investigator's opinion, makes them unsuitable
             for clinical trial participation.

         21. Patient is institutionalized because of legal or regulatory order.