A Multi-Centre, Randomized, Double-Blind, Placebo-Controlled, Dose-Finding and Proof of Concept Study, to Assess the Efficacy, Safety and Tolerability, Pharmacokinetics and Pharmacodynamics of Namilumab/MT203 at 4 Different Subcutaneous Doses – together with an Open-Label, Dose-Escalated Extension to Assess Safety and Efficacy of One Year Treatment - in Subjects with Moderate to Severe Chronic Plaque Psoriasis NEPTUNE

Phase 1

• Conditions: Psoriasis; MedDRA version: 18.0Level: LLTClassification code 10071117Term: Plaque psoriasisSystem Organ Class: 100000004858; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2013-002806-30-LV
• Lead Sponsor: Takeda Development Centre Europe Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-02-10
• Last Update Posted: 17 October 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 120

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

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. alk

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified