Efficacy and Safety of Namilumab (MT203) for Plaque Psoriasis

NCT02129777 | Completed Phase 2 Results DMC

• 4 other identifiers: M1-1188_203U1111-1146-12192013-002806-30172235
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 10

Brief 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.

Conditions

Plaque Psoriasis

Keywords

Drug therapy

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Achieving 75 Percent Reduction From Baseline Psoriasis Area and Severity Index (PASI) Score (PASI75 Response) at Week 12

  PASI is an assessment of psoriasis lesion severity and affected body area combined into single score. The body was divided into 4 sections: head (h), trunk (t), upper (u) and lower (l) extremities. For each section, percent body surface area (A) involved was estimated: 0= No involvement to 6= 90-100 percent (%). Severity was estimated by clinical signs: erythema (E), induration (I), and desquamation (D); scale: 0= no symptoms to 4= very marked. Final PASI = 0.1(Eh + Ih + Dh)Ah + 0.3(Et + It + Dt)At + 0.2(Eu + Iu + Du)Au + 0.4(El + Il + Dl)Al where head: 0.1, upper extremities (arms): 0.2, trunk: 0.3, lower extremities (legs): 0.4 (corresponding to approximately 10%, 20%, 30%, and 40% of body surface area, respectively); total possible score range: 0= no disease to 72= maximal disease. Participants showing at least 75% reduction in PASI score relative to baseline PASI Score are reported.

  Week 12

Secondary Outcomes (17)

• Percentage of Participants Achieving 75 Percent Reduction From Baseline PASI Score (PASI75 Response) at Weeks 2, 4, 6, and 10

  Weeks 2, 4, 6 and 10

• Change From Baseline in PASI Score at Weeks 2, 4, 6, 10, and 12

  Baseline, Weeks 2, 4, 6, 10, and 12

• Percentage of Participants Achieving 50 Percent Reduction From Baseline PASI Score (PASI50 Response) at Weeks 2, 4, 6, 10 and 12

  Weeks 2, 4, 6, 10 and 12

• Percentage of Participants Achieving 90 Percent Reduction From Baseline PASI Score (PASI90 Response) at Weeks 2, 4, 6, 10 and 12

  Weeks 2, 4, 6, 10 and 12

• Percentage of Participants Achieving Greater Than or Equal to (>=) 2 Point Improvement From Baseline in Static Physicians Global Assessment (sPGA) Score at Weeks 2, 4, 6, 10 and 12

  Weeks 2, 4, 6, 10 and 12

Study Arms (7)

Blinded period: Namilumab 300 mg + namilumab 150 mg

EXPERIMENTAL

Namilumab 300 mg (2 separate injections of 150 mg), subcutaneous injection, on Day 1, followed by namilumab 150 mg subcutaneous injection, on Days 15, 43 and 71.

Drug: Namilumab

Blinded period: Namilumab 160 mg + namilumab 80 mg

EXPERIMENTAL

Namilumab 160 mg (2 separate injections of 80 mg), subcutaneous injection, on Day 1, followed by namilumab 80 mg subcutaneous injection, on Days 15, 43 and 71.

Drug: Namilumab

Blinded period: Namilumab 100 mg + namilumab 50 mg

EXPERIMENTAL

Namilumab 100 mg (2 separate injections of 50 mg), subcutaneous injection, on Day 1, followed by namilumab 50 mg subcutaneous injection, on Days 15, 43 and 71.

Drug: Namilumab

Blinded period: Namilumab 40 mg + namilumab 20 mg

EXPERIMENTAL

Namilumab 40 mg (2 separate injections of 20 mg), subcutaneous injection, on Day 1, followed by namilumab 20 mg subcutaneous injection, on Days 15, 43 and 71.

Drug: Namilumab

Blinded period: Placebo

PLACEBO COMPARATOR

Placebo (2 separate injections), subcutaneous injection, on Day 1, followed by placebo, subcutaneous injection, on Days 15, 43 and 71.

Drug: Placebo

Open label: Namilumab 80 mg

EXPERIMENTAL

Namilumab 80 mg subcutaneous injection, at Week 0 and every 4 weeks thereafter up to 52 weeks (active extension period) - if appropriate on the basis of treatment response.

Drug: Namilumab

Open label: Namilumab 150 mg

EXPERIMENTAL

Namilumab 150 mg, subcutaneous injection, from Week 8 and then every 4 weeks thereafter up to 52 weeks (active extension period) - if appropriate on the basis of treatment response.

Drug: Namilumab

Interventions

Namilumab DRUG

Namilumab subcutaneous injection

Also known as: MT203

Blinded period: Namilumab 100 mg + namilumab 50 mg; Blinded period: Namilumab 160 mg + namilumab 80 mg; Blinded period: Namilumab 300 mg + namilumab 150 mg; Blinded period: Namilumab 40 mg + namilumab 20 mg; Open label: Namilumab 150 mg; Open label: Namilumab 80 mg

Placebo DRUG

Placebo subcutaneous injection

Blinded period: Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Is male or female aged 18 to 70 years, inclusive.
• 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.
• Must have been a candidate for, or have received, \>= phototherapy or systemic psoriasis therapy.
• 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).
• 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).
• In the opinion of the investigator, is capable of understanding and complying with protocol requirements.
• 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.

You may not qualify if:

• 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.
• 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.
• Is required to take excluded medications.
• Has a history of hypersensitivity or allergies to namilumab or any of the contents of the formulation.
• Has other forms of psoriasis (eg drug-induced psoriasis, pustular, erythrodermic, exfoliative, inverse and/or guttate psoriasis).
• 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.
• 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.
• 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).
• 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.
• 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.
• 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.
• History of methotrexate treatment-associated lung toxicity.
• 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.
• 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.
• Has an underlying condition that predisposes to infections (eg immunodeficiency, history of poorly controlled diabetes, splenectomy).

Sponsors & Collaborators

• Takeda: lead

Study Sites (10)

Unknown Facility

Calgary, Alberta, Canada

Location

Unknown Facility

Edmonton, Alberta, Canada

Location

Unknown Facility

Barrie, Ontario, Canada

Location

Unknown Facility

Hamilton, Ontario, Canada

Location

Unknown Facility

Markham, Ontario, Canada

Location

Unknown Facility

North Bay, Ontario, Canada

Location

Unknown Facility

Peterborough, Ontario, Canada

Location

Unknown Facility

Richmond Hill, Ontario, Canada

Location

Unknown Facility

Waterloo, Ontario, Canada

Location

Unknown Facility

Québec, Quebec, Canada

Location

Related Publications (1)

• Papp KA, Gooderham M, Jenkins R, Vender R, Szepietowski JC, Wagner T, Hunt B, Souberbielle B; NEPTUNE investigators. Granulocyte-macrophage colony-stimulating factor (GM-CSF) as a therapeutic target in psoriasis: randomized, controlled investigation using namilumab, a specific human anti-GM-CSF monoclonal antibody. Br J Dermatol. 2019 Jun;180(6):1352-1360. doi: 10.1111/bjd.17195. Epub 2018 Nov 2.

  PMID: 30207587 DERIVED

MeSH Terms

Interventions

namilumab

Results Point of Contact

• Title: Medical Director
• Organization: Takeda

trialdisclosures@takeda.com

+1-877-825-3327

Study Officials

• Medical Director, Clinical Science

  Takeda

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2014
• First Posted: May 2, 2014
• Study Start: June 1, 2014
• Primary Completion: September 1, 2015
• Study Completion: February 1, 2016
• Last Updated: April 7, 2017
• Results First Posted: April 7, 2017

Record last verified: 2017-02

Locations

CA (10)