Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as namilumab (MT203), MT203
namilumab · 3 trials · 2 indications
The DAS28-CRP score is a measure of the participant's disease activity calculated using the tender joint count (TJC) \[28 joints\], swollen joint count (SJC) \[28 joints\], general health: patient's global assessment of disease activity \[visual analog scale: 0=no disease activity to 100=maximum disease activity\] and acute phase response: C-Reactive Protein (CRP) for a total possible score of 0 (best) to approximately 10 (worst). Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. A negative change from Baseline indicates improvement. A mixed model repeated measures (MMRM) model with main effects for study site, treatment, visit, and previously failed medication with interactions between visit and treatment, visit and previously failed medication, and visit and baseline value as a covariate and participant as a random effect with an unstructured covariance structure was used for analysis.
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.
Blood was collected for Haematology, Chemistry and Coagulation. Urine was collected for Urinalysis. Alert values for laboratory results include the following: Aspartate aminotransferase (ASAT), alanine aminotransferase (ALAT), gamma-glutamyl-transpeptidase (GGT), alkaline phosphatase (AP), total bilirubin (TBil): \> 3 times upper limit of normal (ULN). Creatinine and Glucose: \> 2 times ULN. Potassium \> 6.0 or \< 3.0 mmol/L. Haemoglobin: Male \< 8.0 ;Female \< 7.0 g/dL. Erythrocytes :Male \< 3.5 x 10\^12/L or \> 7 x 10\^12/L;Female \< 3.0 x 10\^12/L or \> 6.5 x 10\^12/L. White Blood Cells (WBC): \< 2.8 x10\^9/L or \> 16.0 x 10\^9/L. Eosinophils \> 20 % of cells in the WBC differential. Platelet Count \< 75 x 10\^9/L or 600 x 10\^9/L. No alert values were identified for Coagulation or Urinalysis.
Alert values for ECG were: Heart rate \< 35 bpm or \> 120 bpm, QTc acc. to Bazett (absolute value)\> 500 ms or QTc acc. to Bazett (increase versus Baseline (pre-treatment).
Vital signs included Systolic Blood Pressure (BP), Diastolic BP, body temperature, heart rate. Alert values were: BP systolic \> 170 mmHg or \< 85 mmHg, BP diastolic \> 105 mmHg, Difference BP systolic vs. Baseline (pre-treatment) \> 40 mmHg or Pulse rate \< 35 bpm or \> 120 beats per minute (bpm).
Pulmonary function was determined by forced expiratory volume in the first second (FEV1), forced vital capacity (FVC) and peak flow.
The physical examination included body system assessments: eyes, head and neck (including thyroid), ears, nose and throat, lymph nodes, cardiovascular, lungs, mammae, abdomen (liver, spleen), genitals, limbs, central and peripheral nervous system, musculoskeletal system, skin \& nails, mucosae. The Investigator classified abnormal findings as either clinically significant or not clinically significant.
An Adverse Event (AE) was defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Namilumab placebo-matching, SC injection, once on Days 1, 15, 43, 71 and every 4 weeks for 12 weeks. Participants were assessed for response (a 20% improvement from Baseline in both swollen and tender joint counts). If the participant was a responder, the current treatment continued every 4 weeks up to Week 24. If the participant was a non-responder, the participant entered an open-label period and received namilumab 150 mg/mL, SC injection, every 4 Weeks up to Week 24. All participants were on a stable dose of methotrexate tablets (15-25 mg weekly) and folic acid (at least 5 mg/week) orally throughout the duration of the study. |
| Namilumab 20 mg/mL | EXPERIMENTAL | Namilumab 20 mg/mL, subcutaneous (SC) injection, once on Days 1, 15, 43, 71 and every 4 weeks for 12 Weeks. Participants were assessed for response (a 20% improvement from Baseline in both swollen and tender joint counts). If the participant was a responder, the current treatment continued every 4 weeks up to Week 24. If the participant was a non-responder, the participant entered an open-label period and received namilumab 150 mg/mL, SC injection, every 4 Weeks up to Week 24. All participants were on a stable dose of methotrexate tablets (15-25 mg weekly) and folic acid (at least 5 mg/week) orally throughout the duration of the study. |
| Namilumab 80 mg/mL | EXPERIMENTAL | Namilumab 80 mg/mL, SC injection, once on Days 1, 15, 43, 71 and every 4 weeks for 12 Weeks. Participants were assessed for response (a 20% improvement from Baseline in both swollen and tender joint counts). If the participant was a responder, the current treatment continued every 4 weeks up to Week 24. If the participant was a non-responder, the participant entered an open-label period and received namilumab 150 mg/mL, SC injection, every 4 Weeks up to Week 24. All participants were on a stable dose of methotrexate tablets (15-25 mg weekly) and folic acid (at least 5 mg/week) orally throughout the duration of the study. |
| Namilumab 150 mg/mL | EXPERIMENTAL | Namilumab 150 mg/mL, SC injection, once on Days 1, 15, 43, 71 and every 4 weeks for 12 Weeks. Participants were assessed for response (a 20% improvement from Baseline in both swollen and tender joint counts). If the participant was a responder, the current treatment continued every 4 weeks up to Week 24. If the participant was a non-responder, the participant was discontinued from the study. All participants were on a stable dose of methotrexate tablets (15-25 mg weekly) and folic acid (at least 5 mg/week) orally throughout the duration of the study. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| Namilumab 150 mg | EXPERIMENTAL | Namilumab (MT203) 150 mg (low dose), subcutaneous (SC) injection, on Days 1, 15 and 29. |
| Namilumab 300 mg | EXPERIMENTAL | Namilumab (MT203) 300 mg (high dose), SC injection, on Days 1, 15 and 29. |
| Name | Type | Description |
|---|---|---|
| Namilumab | DRUG | Namilumab subcutaneous injection |
| Placebo | DRUG | Namilumab placebo-matching subcutaneous injection |
| Methotrexate | DRUG | Methotrexate tablets |
| Folic/folinic acid | DRUG | Folic/folinic acid tablets |
| namilumab (MT203) | DRUG | administered three times, subcutaneous in the abdomen |
Inclusion Criteria: 1. In the opinion of the investigator, the participant is capable of understanding and complying with protocol requirements. 2. The participant or, when applicable, the participant's legally acceptable representative signs and dates a written, informed consent form and any requi...
Namilumab is an investigational monoclonal antibody being studied for the treatment of plaque psoriasis and rheumatoid arthritis. It has been evaluated in Phase 2 clinical trials for both moderate to severe rheumatoid arthritis, in combination with methotrexate, and for plaque psoriasis. It is not approved for any indication.
Namilumab targets CSF2, also known as granulocyte-macrophage colony-stimulating factor (GM-CSF). It is a monoclonal antibody that acts as an inhibitor of CSF2. By binding this target, namilumab is designed to interfere with the inflammatory signaling pathway implicated in autoimmune and inflammatory conditions such as rheumatoid arthritis and plaque psoriasis.
Namilumab is being developed by Takeda Pharmaceutical Company Limited, which trades on the New York Stock Exchange under the ticker TAK. Takeda is the sponsor of the clinical trials evaluating namilumab in rheumatoid arthritis and plaque psoriasis.
Namilumab is in Phase 2 clinical development. It has completed Phase 1 and Phase 2 trials in rheumatoid arthritis and a Phase 2 trial in plaque psoriasis. Namilumab is investigational and has not been approved by the FDA for any indication.
Namilumab has been studied in three completed trials. NCT02129777 was a Phase 2 trial of namilumab (MT203) for plaque psoriasis in Canada. NCT02379091 was a Phase 2 dose-finding study in combination with methotrexate in moderate to severe rheumatoid arthritis. NCT01317797 was a Phase 1 safety and tolerability trial in mild to moderate rheumatoid arthritis.
Yes, namilumab is also known as MT203. The two names refer to the same monoclonal antibody developed by Takeda. The Phase 2 plaque psoriasis trial and the Phase 1 rheumatoid arthritis trial both used the MT203 designation, while later studies used the name namilumab.