Efficacy and Safety of Namilumab (MT203) for Plaque Psoriasis
Condition: Plaque Psoriasis
MeSH terms: Psoriasis
Intervention: Namilumab; Placebo
Intervention description: Namilumab subcutaneous injection; Placebo subcutaneous injection
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 122.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Drug therapy

Summary:

      The purpose of this study is to establish proof of efficacy for namilumab in moderate to
      severe plaque psoriasis, measured as Psoriasis Area and Severity Index (PASI)75 response rate
      at Week 12.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Is male or female aged 18 to 70 years, inclusive.

          2. Is suffering from active but clinically stable plaque psoriasis (for at least 6
             months) involving >=10% of their body surface area and Psoriasis Area and Severity
             Index (PASI) score >=12.

          3. Must have been a candidate for, or have received, >= phototherapy or systemic
             psoriasis therapy.

          4. A male participant who is non-sterilized and sexually active with a female partner of
             childbearing potential agrees to use adequate contraception from signing of the
             informed consent throughout the duration of the study (including the treatment period
             and 18 weeks after last dose of study medication).

          5. A female participant of childbearing potential who is sexually active with a
             non-sterilized male partner agrees to routinely use adequate contraception from
             signing of the informed consent throughout the duration of the study (including the
             treatment period and 18 weeks after last dose of study medication).

          6. In the opinion of the investigator, is capable of understanding and complying with
             protocol requirements.

          7. The participant or, when applicable, the participant's legally acceptable
             representative signs and dates a written informed consent form and any required
             privacy authorization prior to the initiation of any study procedures.

        Exclusion Criteria:

          1. Has received any investigational agent during an interval equivalent to 5 half- lives
             for that agent agent - or an interval of 30 days if longer - prior to the study
             Baseline clinic visit, or is participating / plans to participate in any other
             clinical trial during this study.

          2. Has received namilumab, any other Granulocyte-Macrophage Colony-Stimulating Factor
             (GM-CSF) / GM-CSF receptor or granulocyte stimulating factor (G-GSF) signaling
             inhibitor either in a previous clinical study or as a therapeutic agent.

          3. Is required to take excluded medications.

          4. Has a history of hypersensitivity or allergies to namilumab or any of the contents of
             the formulation.

          5. Has other forms of psoriasis (eg drug-induced psoriasis, pustular, erythrodermic,
             exfoliative, inverse and/or guttate psoriasis).

          6. Evidence of skin conditions other than psoriasis (eg, eczema) at the time of the
             Screening clinic visit, or between the Screening visit and study drug initiation, that
             would interfere with evaluations of the effect of investigational product on
             psoriasis.

          7. Has a history or evidence of a clinically significant disorder (including but not
             limited to cardiopulmonary, oncologic, renal, metabolic, hematologic or psychiatric),
             condition or disease that, in the opinion of the investigator and Takeda physician
             would pose a risk to participant safety or interfere with the study evaluation,
             procedures or completion.

          8. Evidence of clinically uncontrolled respiratory disease (including sarcoidosis) on the
             basis of data from the subjects' respiratory assessments - including chest X-ray, lung
             function tests (forced expiratory volume in one second [FEV1], forced vital capacity
             [FVC], peak expiratory flow rate [PEFR]) and pulse oximetry performed at Screening.
             The subjects must have saturation of peripheral oxygen (SpO2) ≥ 94%, FEV1 and/or FVC ≥
             60 % of predicted values at Screening and Baseline and no uncontrolled lung disease.
             Subject treatment initiated or modified to control lung disease within 24 weeks prior
             to Screening must be considered exclusionary.

          9. History of clinically significant interstitial lung disease - e.g. chronic or
             recurrent pulmonary infection where macrophages are important for the clearance of the
             infection (such as Pneumocystis (carinii) jiroveci pneumonia, allergic
             bronchopulmonary aspergillosis, Nocardia infections, Actinomyces infection).

         10. Presence or history of active tuberculosis (TB) or latent TB infection, where no
             anti-TB treatment has been given or where successful completion of an appropriate
             course of anti-TB therapy cannot be documented.

         11. A positive QuantiFERON-TB Gold test and / or evidence of active or latent TB by chest
             X- ray, not accompanied by initiation of an approved regimen of anti-TB therapy at
             least 12 months prior to the Baseline clinic visit.

         12. Has a history of severe chronic obstructive pulmonary disease (COPD) and / or history
             of severe COPD exacerbation(s), or a history of asthma with exacerbations requiring
             hospitalization, within the last 12 months prior to the Screening visit.

         13. History of methotrexate treatment-associated lung toxicity.

         14. Has a history of cancer within the last 10 years except for adequately managed basal
             cell or squamous cell carcinoma of the skin or in situ carcinoma of the cervix treated
             and considered cured.

         15. Has a history of treatment with anti-cancer chemotherapy (e.g. alkylating agents,
             anti-metabolites, purine analogues) and/or monoclonal antibodies, or has received
             GM-CSF / G-CSF treatment associated with chemotherapy within the last 5 years.

         16. Has an underlying condition that predisposes to infections (eg immunodeficiency,
             history of poorly controlled diabetes, splenectomy).

         17. Has any clinically significant illness within 4 weeks prior to the first dose of study
             medication or during the study - including acute or chronic infectious disease, which
             may influence the outcome of the study.

         18. Has a known history of infection with hepatitis B virus, hepatitis C virus, or human
             immunodeficiency virus (HIV), or has serological findings at the Screening visit which
             indicate active or latent hepatitis B, hepatitis C or HIV infection.

         19. Has, in the judgment of the investigator, clinically significant abnormal clinical
             laboratory parameters at Screening including, but not limited to: Hemoglobin <8.5
             g/dL, Neutrophils <1500/mm^3, Platelet count <75 000 cells/mm^3 and AST or ALT >2 x
             ULN.

         20. Has a history of drug abuse (defined as any illicit drug use), or a history of alcohol
             abuse within 2 years prior to the Screening visit.

         21. Any other condition that, in the judgment of the investigator, might cause this study
             to be detrimental to the participant's health.

         22. If female, is (a) pregnant / lactating / intending to become pregnant before or within
             the period of 18 weeks immediately after receiving the last dose of study medication;
             (b) intending to donate ova during this time period.

         23. Intends to donate sperm during the course of this study or within a period of 18 weeks
             after receiving the last dose of study medication.

         24. Is an immediate family member, study site employee, or is in a dependent relationship
             with a study site employee involved in conduct of this study (eg, spouse, parent,
             child, sibling), or may consent under duress.