Psoriasis MedDRA version: 18.0 Level: LLT Classification code 10071117 Term: Plaque psoriasis System Organ Class: 100000004858
Conditions
Sponsors
Takeda Development Centre Europe Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. The subject is male or female aged 18 to 70 years, inclusive. 2. The subject is suffering from stable plaque psoriasis (for at least 6 months) involving =10% of their body surface area, PASI score =12. 3. The subject must have been a candidate for, or have received, =1 phototherapy or systemic psoriasis therapy at the time of inclusion. 4. In the opinion of the investigator, the subject is capable of understanding and complying with protocol requirements. 5. The subject signs and dates a written informed consent form and any required privacy authorization prior to the initiation of any study procedures. 6. A male subject who is nonsterilized 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 this study (including the treatment period and 18 weeks after last dose of study medication). 7. A female subject of childbearing potential who is sexually active with a nonsterilized male partner agrees to routinely use adequate contraception from signing of the informed consent throughout the duration of this study (including the treatment period and 18 weeks after last dose of study medication). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 110 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: 1.The subject has received any investigational agent during an interval equivalent to 5 half-lives for that agent, or an interval of 30 days if longer, prior to the study Baseline clinic visit. Alternatively, the subject is participating or planning to participate in any other clinical study during this study. 2.The subject has received namilumab, any other GM-CSF / G-CSF receptor blocker or signaling inhibitor either in a previous clinical study or as a therapeutic agent. 3.The subject is required to take excluded medications (see Section 7.3 below). 4.The subject has a history of hypersensitivity or allergies to any of the contents of the namilumab formulation. 5.The subject 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 (e.g., 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.The subject 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/or Takeda physician would pose a risk to subject 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 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 of active TB. 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.The subject 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 (including emergency or acute care treatments), within the last 12 months prior to the Screening visit. 13.History of methotrexate treatment-associated lung toxicity. 14.The subject 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.The subject has a history of treatment with anti-cancer chemotherapy (e.g. alky
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To establish proof of efficacy of namilumab in moderate to severe plaque psoriasis, as measured by the proportion of subjects achieving a reduction in Psoriasis Area and Severity Index (PASI) scores = 75% from baseline (hereafter referred to as PASI75) response rate at week 12.;Secondary Objective: • To investigate efficacy on skin involvement - measured as mean change from Baseline in PASI score at Weeks 2, 4, 6, 10, 12, 14, 22 and 28. • To investigate efficacy on skin involvement - measured as PASI50, PASI75 and PASI90 response rates at Weeks 2, 4, 6, 10, 12, 14, 22 and 28. • To investigate efficacy on skin involvement - measured as mean change from Baseline in static Physician’s Global Assessment score (sPGA) at Weeks 2, 4, 6, 10, 12, 14, 22 and 28. • To investigate efficacy on skin involvement - measured as the proportions of subjects achieving = 2 point improvement in sPGA score and complete psoriasis clearance (sPGA scores 0-1) respectively between Baseline and Weeks 2, 4, 6, 10, 12, 14, 22 and 28. • To investigate efficacy on skin - measured as change in affected body surface area (BSA) from Baseline at Weeks 2, 4, 6, 10, 12, 14, 22 and 28. See protocol for complete list.;Primary end point(s): The primary endpoint for the study is the proportion of subjects achieving a PASI75 improvement from baseline at week 12. Data comparisons will be made to evaluate superiority in efficacy of each of the four namilumab dose levels to placebo.;Timepoint(s) of evaluation of this end point: Week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Proportion of subjects who achieve PASI75, assessed at all applicable post-Baseline visits other than Week 12. • Mean change from Baseline in PASI score, assessed at all applicable post-Baseline visits. • Proportion of subjects who achieve PASI50, assessed at all applicable post-Baseline visits. • Proportion of subjects who achieve PASI90, assessed at all applicable post-Baseline visits. • Proportion of subjects achieving = 2 point improvement in sPGA score, assessed (using a 6-point rating scale with range 0 = Clear to 5 = Very severe) at all applicable post-Baseline clinic visits. • Proportion of subjects achieving sPGA clear or almost clear/minimal (sPGA = 0 or 1 using the 6-point rating scale with range 0 = Clear to 5 = Very severe), assessed at all applicable post-Baseline visits. • Mean change from Baseline in sPGA score, assessed (using a 6-point rating scale with range 0 = Clear to 5 = Very Severe) at all applicable post-baseline visits. • Mean change from Baseline in affected body surface area (BSA), assessed at all applicable post-Baseline visits. • Mean change from Baseline in Visual Analogue Scale (VAS) itching, assessed at all applicable post-Baseline visits. • Mean change from Baseline in VAS joint pain, assessed at all applicable post-Baseline visits. • Mean change from Baseline in VAS morning stiffness and duration of morning stiffness, assessed at all applicable post-Baseline visits. • Change in score from Baseline to Weeks 12 and 28 in Dermatology Life Quality Index (DLQI). • Change in score from Baseline to Weeks 12 and 28 in Short Form 36 Health Survey (SF-36 v. II). • Change in score from Baseline to Weeks 12 and 28 in EuroQoL Health Questionnaire (EQ-5D). • Mean change from Baseline for Nail Psoriasis Severity Index (NAPSI) - finger nail assessments at all applicable post-Baseline visits.;Timepoint(s) of evaluation of this end point: Please see E.5.2 for timepoints corresponding to each secondary endpoint | — |
Countries
Canada, Denmark, Germany, Latvia, Poland
Contacts
Public ContactClinical Study Manager
Takeda Development Centre Europe Ltd.
Outcome results
None listed