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Plaque PsoriasisPhase 2NCT02129777

Efficacy and Safety of Namilumab (MT203) for Plaque Psoriasis

A Phase 2 study testing Namilumab in people with Plaque Psoriasis, run by Takeda at 10 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Plaque Psoriasis
What is being tested?
Namilumab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
122 participants
Where
10 sitesCanada
Study dates
Jun 2014to Feb 2016
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 24Show fewer
  • 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.
  • 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.
  • 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).
  • 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.
  • 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.
  • 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.
  • 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.
  • Any other condition that, in the judgment of the investigator, might cause this study to be detrimental to the participant's health.
  • 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.
  • 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.
  • 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.

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

Canada10 sites

  • Study site

    Barrie, Ontario

  • Study site

    Calgary, Alberta

  • Study site

    Edmonton, Alberta

  • Study site

    Hamilton, Ontario

  • Study site

    Markham, Ontario

  • Study site

    North Bay, Ontario

  • Study site

    Peterborough, Ontario

  • Study site

    Québec, Quebec

  • Study site

    Richmond Hill, Ontario

  • Study site

    Waterloo, Ontario

Other trials in Canada

About this study

Official title: 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

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.

Read the detailed description

The drug tested in this study is called namilumab. Namilumab was tested to prove its effectiveness in treating moderate to severe chronic plaque psoriasis. This study looked at improvement of plaque psoriasis in participants who take namilumab.

The study enrolled 122 participants. Participants were randomly assigned (by chance, like flipping a coin) to one of five treatment groups that were undisclosed to the patient and study doctor during the study (unless there was an urgent medical need):

  • Namilumab subcutaneous injection 300 mg Day 1, 150 mg Days 15, 43 and 71
  • Namilumab subcutaneous injection 160 mg Day 1, 80 mg Days 15, 43 and 71
  • Namilumab subcutaneous injection 100 mg Day 1, 50 mg Days 15, 43 and 71
  • Namilumab subcutaneous injection 40 mg Day 1, 20 mg Days 15, 43 and 71
  • Placebo (dummy inactive subcutaneous injection) - this is a liquid solution that looks like the study drug but has no active ingredient Days 1, 15, 43 and 71.

This study consisted of two parts. Eligible participants received 10 weeks of treatment with double-blinded study medication, followed by an extended treatment period (active extension period, intended to be 52 weeks) with open-label study medication. At Week 12, participants were assessed for primary endpoint response, which determined the course of their progression through the open-label treatment period. Participants who showed >=75% reduction of Baseline (Day 1) PASI at Week 12, "Responders", began a washout interval (for a maximum of 24 weeks) with no use of study medication: this interval continued until a partial (25%) loss of Week 12 treatment response is recorded in assessments conducted on a 2-weekly basis - thereby prompting the start of dosing with open-label (OL) study medication (Day 0 OL through Week 52 OL). In contrast, participants who did not show >=75% reduction of Baseline PASI score at Week 12, "Partial/Non-Responders", began the open-label extension period 4 weeks after the final dose of blinded study medication.

Participants were then followed-up through an 18-week post-treatment assessment period during which no medication was given. During the open-label extension period participants began dosing with 80 mg namilumab; however, if an inadequate treatment response was recorded, then dose escalation to 150 mg namilumab was implemented.

Being tested
Namilumab, Placebo
Keywords
Drug therapy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NamilumabDrug

    Also called MT203

    Namilumab subcutaneous injection

  • PlaceboDrug

    Placebo subcutaneous injection

Study groups in NCT02129777
Study groupRoleWhat they receive
Blinded period: Namilumab 300 mg + namilumab 150 mgExperimentalNamilumab 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.
Receives: Drug: Namilumab
Blinded period: Namilumab 160 mg + namilumab 80 mgExperimentalNamilumab 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.
Receives: Drug: Namilumab
Blinded period: Namilumab 100 mg + namilumab 50 mgExperimentalNamilumab 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.
Receives: Drug: Namilumab
Blinded period: Namilumab 40 mg + namilumab 20 mgExperimentalNamilumab 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.
Receives: Drug: Namilumab
Blinded period: PlaceboPlacebo comparatorPlacebo (2 separate injections), subcutaneous injection, on Day 1, followed by placebo, subcutaneous injection, on Days 15, 43 and 71.
Receives: Drug: Placebo
Open label: Namilumab 80 mgExperimentalNamilumab 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.
Receives: Drug: Namilumab
Open label: Namilumab 150 mgExperimentalNamilumab 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.
Receives: Drug: Namilumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Week 12

Secondary outcomes (17)

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

    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.

    Measured: Weeks 2, 4, 6 and 10

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

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

  3. Percentage of Participants Achieving 50 Percent Reduction From Baseline PASI Score (PASI50 Response) at Weeks 2, 4, 6, 10 and 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 50% reduction in PASI score relative to baseline PASI Score are reported.

    Measured: Weeks 2, 4, 6, 10 and 12

  4. Percentage of Participants Achieving 90 Percent Reduction From Baseline PASI Score (PASI90 Response) at Weeks 2, 4, 6, 10 and 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 90% reduction in PASI score relative to baseline PASI Score are reported.

    Measured: Weeks 2, 4, 6, 10 and 12

  5. 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

    sPGA for psoriasis is scored on a 6-point scale, reflecting a global consideration of the erythema, plaque elevation and skin scaling across all psoriatic lesions. sPGA of psoriasis scale ranges from 0 (clear) to 5 (very severe). Participants who had >=2 point improvement are reported.

    Measured: Weeks 2, 4, 6, 10 and 12

  6. Percentage of Participants Achieving a sPGA Response of Clear (0) or Almost Clear (1) at Weeks 2, 4, 6, 10 and 12

    sPGA for psoriasis is scored on a 6-point scale, reflecting a global consideration of the erythema, plaque elevation and skin scaling across all psoriatic lesions. sPGA of psoriasis scale ranges from 0 (clear) to 5 (very severe). 'Clear' and 'Almost clear' included all participants who had scored a 0 or 1.

    Measured: Weeks 2, 4, 6, 10 and 12

  7. Change From Baseline in sPGA Score at Weeks 2, 4, 6, 10, and 12

    sPGA for psoriasis is scored on a 6-point scale, reflecting a global consideration of the erythema, plaque elevation and skin scaling across all psoriatic lesions. sPGA of psoriasis scale ranges from 0 (clear) to 5 (very severe).

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

  8. Change From Baseline in Affected Body Surface Area (BSA) at Weeks 2, 4, 6, 10, and 12

    Assessment of BSA with psoriasis was performed by means of the palm method, where the palm of the participant's hand represented 1% of BSA. The affected areas were then calculated by their size compared to the participant's palm.

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

  9. Change From Baseline in Visual Analogue Scale (VAS) Itching Score at Weeks 2, 4, 6, 10, and 12

    Assessments were performed using a portable electronic device, which was kept and used by the participant throughout the duration of the study. Participants were asked to indicate their level of itching by marking a horizontal line with "No itch" at the left extreme and "Worst itch imaginable" at the right extreme (scale ranging from 0 - 10, but not shown on the line). Each assessment was intended to capture the severity of itching experienced during the previous 24 hours.

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

  10. Change From Baseline in VAS Joint Pain Score at Weeks 2, 4, 6, 10, and 12

    Assessments were performed using a portable electronic device, which was kept and used by the participant throughout the duration of the study. Participants were asked to indicate their severity of joint pain by marking a horizontal line with "No pain" at the left extreme and "Worst pain imaginable" at the right extreme (scale ranging from 0 - 10, but not shown on the line). Each assessment was intended to capture the severity of pain experienced during the previous 24 hours.

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

  11. Change From Baseline in VAS Morning Stiffness Score at Weeks 2, 4, 6, 10, and 12

    Assessments were performed using a portable electronic device, which was kept and used by the participant throughout the duration of the study. Participants were asked to indicate their level of morning stiffness by marking a horizontal line with "No stiffness" at the left extreme and "Very severe stiffness" at the right extreme (scale ranging from 0 - 10, but not shown on the line). Each assessment was intended to capture the severity of stiffness experienced by the participant since waking on that particular day.

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

  12. Change From Baseline in Duration of Morning Stiffness at Weeks 2, 4, 6, 10, and 12

    Assessments were performed using a portable electronic device, which was kept and used by the participant throughout the duration of the study. Duration of stiffness was elicited in response to a standard question included in the portable device.

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

  13. Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 12

    The DLQI is a 10-point rating scale for determining the impact of dermatological conditions on the participant's quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). Maximum total score is 30, where 0-1 represents "No effect at all on participant's life" and 21-30 "Extremely large effect on participant's life" - higher scores indicating poorer quality of life.

    Measured: Baseline, Week 12

  14. Change From Baseline in Short Form 36 Health Survey (SF-36) at Week 12

    SF-36 is a standardized survey evaluating 8 aspects of functional health and well-being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. These 8 aspects are summarized as physical and mental health summary scores. The score range for the physical and mental health scores is 0-100 (100=highest level of functioning).

    Measured: Baseline, Week 12

  15. Change From Baseline in EuroQoL Health Questionnaire (EQ-5D)- Index Score at Week 12

    EQ-5D-Index score is a generic, multidimensional, health-related, quality-of-life instrument. The profile allows participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The score ranges from -0.594 to 1.000. The higher score indicates a better health state perceived by the participant.

    Measured: Baseline, Week 12

  16. Change From Baseline in EQ-5D-VAS Score at Week 12

    EQ-5D-VAS is a participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 mm ("Worst imaginable health state") to 100 mm ("Best imaginable health state"); higher scores indicate a better health state.

    Measured: Baseline, Week 12

  17. Mean Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Score at Weeks 2, 4, 6, 10, and 12

    The NAPSI quantifies severity of nail psoriasis by evaluating the presence or absence of psoriatic manifestations on the nail matrix (pitting, leukonychia, red spots on lunula, crumbling) and nail bed (onycholysis, splinter hemorrhages, subungual hyperkeratosis, oil drop [salmon patch dyschromia]). Each finger nail divided with imaginary lines into quadrants and scored for both nail matrix and nail bed psoriasis (range from 0 [absence of psoriasis] to 4 [presence of psoriasis in all 4 quadrants]). The total NAPSI score equals the sum of scores for all of the finger nails evaluated and ranges from 0 to 80. Higher scores = more severe psoriasis.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 May 2014 (estimated)
  2. Study startJun 2014
  3. Primary completionSep 2015
  4. Study completionFeb 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
122 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02129777
Sponsor's protocol ID
M1-1188_203
Other IDs
U1111-1146-1219, 2013-002806-30, 172235
Status last verified
Feb 2017
First submitted
14 Apr 2014
Last updated
7 Apr 2017
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 30207587

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Namilumab in people with Plaque Psoriasis, run by Takeda at 10 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Apr 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants Achieving 75 Percent Reduction From Baseline Psoriasis Area and Severity Index (PASI) Score (PASI75 Response) at Week 12 (time frame: Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02129777, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2017.

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