Psoriasis
Conditions
Keywords
Psoriasis, MSB0010841, Anti-IL17A/F Nanobody, M1095
Brief summary
This is a multicenter, Phase 1, randomized, double-blind, placebo-controlled trial in subjects with moderate to severe psoriasis to assess the safety, tolerability, immunogenicity, pharmacokinetics (PK), pharmacodynamics (PD) and efficacy of multiple subcutaneous ascending doses of MSB0010841 (Anti-interleukin-17A/F \[Anti-IL-17A/F\] Nanobody).
Interventions
MSB0010841(Anti- IL-17A/F Nanobody) will be administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
Placebo matched to MSB0010841 will be administered as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
Sponsors
Study design
Eligibility
Inclusion criteria
* Chronic plaque psoriasis for at least 6 months before screening * Greater than or equal to (\>=) 10% of BSA with plaques * Psoriasis Area and Severity Index (PASI) \>=12 * Static Physician's Global Assessment (sPGA) \>=3 (where scores range from 0 \[clear of disease\] to 5 \[severe disease\]) at the screening and baseline visits * Other protocol defined inclusion criteria could apply
Exclusion criteria
* Any condition, including protocol-specified laboratory findings and findings in the medical history or in the pre-trial assessments which in the Investigator's opinion constitutes a risk or a contraindication for the subject's participation in the trial or that could interfere with the trial objectives, conduct or evaluation * Currently having a form of non-plaque psoriasis as specified in the protocol * Drug induced psoriasis * Biological treatments as specified in the protocol, within 3 months prior to Day 1 * Systemic immunosuppressants or phototherapy as specified in the protocol, within 1 month prior to Day 1 * Use of anti-coagulant medications and/or antiplatelet medications as defined in the protocol * Use of aspirin as defined in the protocol * Topical corticosteroid treatments other than low-strength or lower-mid strength corticosteroids on the face, scalp, axillae, and/or groin within 1 month prior to Day 1 * Any previous treatment with an agent targeting interleukin (IL)-17, IL-12 and/or IL-23 as specified in the protocol * Other protocol defined
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Observed Serum Concentration Immediately Before Second Dose (Cpre) of MSB0010841 | Pre-dose (0 hours) on Day 15 | The observed serum concentration immediately before second dose. |
| Percentage Peak-Trough Fluctuation (PTF) Post First Dose of MSB0010841 | 0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336 hours post-first dose (Day 1) | The peak trough fluctuation within one dosing interval, calculated as PTF (%) = (\[Cmax - Cmin\]/Cav ) multiplied by 100 |
| Percentage Peak-Trough Fluctuation (PTF) Post Third Dose of MSB0010841 | 0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336, 504, 816, 1056, 1344 hours post-third dose (Day 29) | The peak trough fluctuation within one dosing interval, calculated as PTF (%) = (\[Cmax - Cmin\]/Cav ) multiplied by 100 |
| Accumulation Ratio of Cmax (Racc (Cmax)) | 0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336 hours post-first dose (Day 1) and 0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336, 504, 816, 1056, 1344 hours post-third dose (Day 29) | Accumulation ratio for Cmax was calculated as Cmax, after third dose / Cmax, after first dose. |
| Accumulation Ratio of AUC (Racc(AUC)) | 0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336 hours post-first dose (Day 1) and 0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336, 504, 816, 1056, 1344 hours post-third dose (Day 29) | Accumulation ratio for AUC, calculated as area under the serum concentration-time curve within one complete dosing interval at third dose divided by area under the serum concentration-time curve within one complete dosing interval at first dose. |
| Maximum Observed Concentration (Cmax) Post Second Dose of MSB0010841 | 0 hours (pre-dose), 24, 72, 96, 168, 336 hours post-second dose (Day 15) | — |
| Number of Subjects With Treatment Emergent Adverse Events (TEAEs) | Baseline up to Day 85 | An adverse event (AE) was defined as any untoward medical occurrence which does not necessarily have a causal relationship with this the study drug. An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug or worsening of pre-existing medical condition, whether or not related to study drug. TEAEs were the AEs occurring or worsening after treatment administration. |
| Number of Subjects With Local Injection Site Reactions (ISRs) | Day 1, 2,8, 15, 16, 22, 29, 30, 36, 43 | The injection site was assessed by the Principal Investigator (PI) or his/her designee for local reactions such as redness, swelling, indurations or bruising, and by the subject for itching. Redness and bruising were scaled as None (no visible redness or bruising present); Mild (less than or equal to \[\<=\] 2.0 centimeters \[cm\] redness or bruising area); Moderate (greater than \[\>\] 2 to \<=5.0 cm redness or bruising area); Severe (\>5.0 cm redness or bruising area). Swelling was scaled as None (no swelling detected); Mild (palpable 'firmness' only); Moderate (\<= 4 cm swelling); Severe (\>4 cm swelling). Induration was scaled as None (no induration); Mild (able to move skin parallel to plane (sliding) and perpendicular to skin (pinching up); Moderate (able to slide skin, unable to pinch skin); Severe (unable to slide or pinch skin). Itching was scaled as No itching; Mild itching; Moderate itching and Severe itching. Subjects who reported any of the local ISRs were reported. |
| Amount of Pain at Injection Site Assessed By Visual Analog Scale (VAS) | Day 1, 2, 8, 15, 16, 22, 29, 30, 36, 43 | Subjects were asked to assess their severity of injection site pain on a 100 millimeter (mm) VAS, where 0 = no pain and 100 = worst possible pain. Mean of amount of pain was calculated for the subjects having a value \> 0. Maximum values per subjects (over injection site areas) are used for counting the amount of pain at injection site. Maximum pain scores recorded among all participants analysed in each arm are reported for each time point. |
| Percentage of Subjects With Anti-MSB0010841 Binding Antibodies (Anti-Drug Antibodies [ADA]) | Baseline up to Day 85 | Data were presented for MSB0010841 combined group and placebo. |
| Levels of Anti-MSB0010841 Antibody Titers | Day 8, 15 (pre-dose), 22, 29 (pre-dose), 36, 43, 63 and 85 | — |
| Levels of Pre-existing Anti-MSB0010841 Antibody Titers | Pre-dose on Day 1 | — |
| MSB0010841 Serum Concentration Over Time After First Dose | 0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336 hours post-first dose (Day 1) | — |
| MSB0010841 Serum Concentration Over Time After Second Dose | 0 hours (pre-dose), 24, 72, 96, 168, 336 hours post-second dose (Day 15) | — |
| MSB0010841 Serum Concentration Over Time After Third Dose | 0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336, 504, 816, 1056, 1344 hours post-third dose (Day 29) | — |
| Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUC0-t) Post First Dose of MSB0010841 | 0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336 hours post-first dose (Day 1) | Area under the serum concentration-time curve (AUC) from time zero to the last sampling time point at which the concentration is at or above lower limit of quantification (LLOQ). |
| Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUC0-t) Post Third Dose of MSB0010841 | 0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336, 504, 816, 1056, 1344 hours post-third dose (Day 29) | Area under the serum concentration-time curve (AUC) from time zero to the last sampling time point at which the concentration is at or above LLOQ. |
| Area Under the Concentration-Time Curve From Time Zero up to Time Tau (AUCtau) Post First Dose of MSB0010841 | 0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336 hours post-first dose (Day 1) | Area under the concentration-time curve from time zero up to time Tau, where Tau is the dosing interval (336 hours). |
| Area Under the Concentration-Time Curve From Time Zero up to Time Tau (AUCtau) Post Third Dose of MSB0010841 | 0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336 hours post-third dose (Day 29) | Area under the concentration-time curve from time zero up to time Tau, where Tau is the dosing interval (336 hours). |
| Area Under the Concentration-time Curve From Time Zero to Infinity (AUC 0-inf) Post Third Dose of MSB0010841 | 0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336, 504, 816, 1056, 1344 hours post-third dose (Day 29) | Area under the serum concentration-time curve from time zero to infinity (AUC0-inf). AUC0-infcalculated as AUC0-t + AUCextra. AUCextra represents the extrapolated part of AUC0-inf calculated by Clast calc/λz, where Clast calc is the calculated concentration at the last sampling time point at which the measured concentration is at or above LLOQ and λz is the terminal rate constant determined from the terminal slope of the log transformed concentration curve using linear regression on terminal data points of the curve. |
| Observed Serum Concentration Immediately Before First Dose (Cpre) of MSB0010841 | Pre-dose (0 hours) on Day 1 | The observed serum concentration immediately before the first dose. |
| Observed Serum Concentration Immediately Before Third Dose (Cpre) of MSB0010841 | Pre-dose (0 hours) on Day 29 | The observed serum concentration immediately before the third dose. |
| Minimum Concentration Observed (Cmin) During First Dosing Interval of MSB0010841 | 0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336 hours post-first dose (Day 1) | The observed minimum serum concentration determined directly from the serum concentration-time profile of each subject. |
| Minimum Concentration Observed (Cmin) During Third Dosing Interval of MSB0010841 | 0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336, 504, 816, 1056, 1344 hours post-third dose (Day 29) | The observed minimum serum concentration determined directly from the serum concentration-time profile of each subject. |
| Maximum Concentration Observed (Cmax) Post First Dose of MSB0010841 | 0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336 hours post-first dose (Day 1) | — |
| Maximum Concentration Observed (Cmax) Post Third Dose of MSB0010841 | 0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336, 504, 816, 1056, 1344 hours post-third dose (Day 29) | — |
| Average Concentration (Cav) Post First Dose of MSB0010841 | 0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336 hours post-first dose (Day 1) | Cav was calculated by AUCtau/tau. Where tau is the dosing interval (336 hours). |
| Average Concentration (Cav) Post Third Dose of MSB0010841 | 0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336, 504, 816, 1056, 1344 hours post-third dose (Day 29) | Cav was calculated by AUCtau/tau. Where tau is the dosing interval (336 hours). |
| Mean Residence Time (MRT0-t) Post First Dose of MSB0010841 | 0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336 hours post-first dose (Day 1) | MRT is the average time at which the number of absorbed molecules reside in the body, after single-dose administration, and calculated as AUMC(0-t)/AUC(0-t) where AUMC(0-t) is area under the plasma concentration-time first moment curve from time zero to time t (336 hours) and AUC(0-t) is the area under the plasma concentration-time curve from time zero to tome t (336 hours). |
| Mean Residence Time (MRT0-t) Post Third Dose of MSB0010841 | 0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336 hours post-third dose (Day 29) | MRT is the average time at which the number of absorbed molecules reside in the body, after single-dose administration, and calculated as AUMC(0-t)/AUC(0-t) where AUMC(0-t) is area under the plasma concentration-time first moment curve from time zero to time t (336 hours) and AUC(0-t) is the area under the plasma concentration-time curve from time zero to tome t (336 hours). |
| Mean Residence Time of Drug in the Body From Time Zero Extrapolated to Infinity (MRT(0-inf) Post Third Dose of MSB0010841 | 0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336, 504, 816, 1056, 1344 hours post-third dose (Day 29) | Mean residence time of drug in the body from time zero extrapolated to infinity, based on the last predicted concentration at tlast. |
| Time to Reach Maximum Observed Concentration (Tmax) Post First Dose of MSB0010841 | 0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336 hours post-first dose (Day 1) | — |
| Time to Maximum Observed Concentration (Tmax) Post Second Dose of MSB0010841 | 0 hours (pre-dose), 24, 72, 96, 168, 336 hours post-second dose (Day 15) | — |
| Time to Reach Maximum Observed Concentration (Tmax) Post Third Dose of MSB0010841 | 0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336, 504, 816, 1056, 1344 hours post-third dose (Day 29) | — |
| Apparent Terminal Half-life (t1/2) Post Third Dose of MSB0010841 | 0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336, 504, 816, 1056, 1344 hours post-third dose (Day 29) | Terminal half-life is the time measured for the concentration to decrease by one half. Terminal half-life is calculated by dividing the natural logarithm to the base e (Log e) multiplied by (\*) 2/ λz, where 'λz' is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. |
| Terminal Rate Constant (λz) Post Third Dose of MSB0010841 | 0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336, 504, 816, 1056, 1344 hours post-third dose (Day 29) | Terminal rate constant was determined from the terminal slope of the logtransformed concentration curve using linear regression on terminal data points of the curve |
| Apparent Clearance (CL/f) Post Third Dose of MSB0010841 | 0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336, 504, 816, 1056, 1344 hours post-third dose (Day 29) | Clearance of a drug was a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Apparent clearance after oral dose (CL/f) is influenced by the fraction absorbed. |
| Apparent Volume of Distribution During Terminal Phase (Vz/f) Post Third Dose of MSB0010841 | 0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336, 504, 816, 1056, 1344 hours post-third dose (Day 29) | Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired serum concentration of a drug. Apparent volume of distribution during the terminal phase, calculated as Vz = Dose/AUC0-inf multiplied by elimination rate constant \[λz\]) following first dose and Dose/(AUCtau multiplied by λz) after third dose. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Day 43 | Baseline, Day 43 | PASI: a physician assessed index that measured psoriasis severity and evaluated erythema, infiltration, and desquamation (scaling) on different body areas including the head, upper extremities, the trunk, and lower extremities. T Erythema, infiltration, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The total qualitative score (sum of erythema, thickness, and scaling scores) was multiplied by the degree of involvement for each anatomic region and then multiplied by a constant. These values for each anatomic region are summed to yield the PASI score. PASI score ranged from 0 to 72, with higher scores reflecting greater disease severity. PASI 50% or 75% was defined as the percentage of subjects who achieved \>=50 or 75% improvement in PASI score from Baseline. |
| Percentage of Subjects With Static Physician's Global Assessment (sPGA) Score of Minimal or Clear and With at Least 2 Level Reduction From Baseline | Day 8, 15, 22, 29, 36, 43, 50, 85 | The static Physician's Global Assessment (sPGA) scale rated the investigator's overall clinical assessment of a subjects plaque thickness, erythema, and scaling on a 6-point scale ranging from 0 (clear, except for residual discoloration) to 5 (majority of plaques have severe thickness, erythema, and scale). To assign a sPGA score, the investigator examined all psoriatic lesions and assigned a severity score ranging from 0 to 5 for thickness, erythema, and scaling. Scores for thickness, erythema, and scaling are summed and the mean of these 3 scores equals the overall sPGA score. Overall sPGA score ranged from 0 to 5, where lower scores indicate clinical improvement. Percentage of subjects who achieved a sPGA rating of 0 (clear) or 1 (minimal) and had at Least 2 level reduction from Baseline score were reported. |
| Mean Percent Change From Baseline in the Body Surface Area (BSA) Affected by Psoriasis at Day 8, 15, 22, 29, 36, 43, 50 and 85 | Baseline, Day 8, 15, 22, 29, 36, 43, 50 and 85 | The BSA is the physician's evaluation for the extent of disease. The entire body area is divided into 4 districts: head, upper limbs, trunk and lower limbs to which corresponds the 10%, 20%, 30% and 40% of the entire body surface respectively. The investigator assesses the percentage of the subjects' body surface area affected by psoriasis in each district. The final affected BSA value is the sum of the percentage of each district. |
| Percentage of Subjects With Exacerbation of Psoriasis | Baseline up to Day 85 | Psoriasis exacerbation was defined as either a worsening of 25% over the baseline value of the PASI score (PASI score at any visit \>=125% of baseline PASI). |
| Percentage of Subjects With 50% or 75% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score | Baseline up to Day 85 | PASI: a physician assessed index that measured psoriasis severity and evaluated erythema, infiltration, and desquamation (scaling) on different body areas including the head, upper extremities, the trunk, and lower extremities. T Erythema, infiltration, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The total qualitative score (sum of erythema, thickness, and scaling scores) was multiplied by the degree of involvement for each anatomic region and then multiplied by a constant. These values for each anatomic region are summed to yield the PASI score. PASI score ranged from 0 to 72, with higher scores reflecting greater disease severity. PASI 50% or 75% was defined as the percentage of participants who achieved \>=50 or 75% improvement in PASI score from Baseline. |
Countries
Germany
Participant flow
Pre-assignment details
A total of 41 subjects were randomized in the trial and included in the Safety analysis set.
Participants by arm
| Arm | Count |
|---|---|
| MSB0010841 30 mg MSB0010841 (Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks. | 8 |
| MSB0010841 60 mg MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks. | 8 |
| MSB0010841 120 mg MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks. | 8 |
| MSB0010841 240 mg MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks. | 9 |
| Placebo Placebo matched to MSB0010841 was administered as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks. | 8 |
| Total | 41 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 1 | 1 | 0 |
| Overall Study | Quantiferon Positivity | 0 | 0 | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | MSB0010841 30 mg | MSB0010841 240 mg | MSB0010841 60 mg | MSB0010841 120 mg | Placebo | Total |
|---|---|---|---|---|---|---|
| Age, Continuous | 48.6 years STANDARD_DEVIATION 13.24 | 44.8 years STANDARD_DEVIATION 15.65 | 42.1 years STANDARD_DEVIATION 19.57 | 43.8 years STANDARD_DEVIATION 13.59 | 46.1 years STANDARD_DEVIATION 14.57 | 45.1 years STANDARD_DEVIATION 14.87 |
| Gender Female | 1 Participants | 1 Participants | 0 Participants | 2 Participants | 2 Participants | 6 Participants |
| Gender Male | 7 Participants | 8 Participants | 8 Participants | 6 Participants | 6 Participants | 35 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 5 / 8 | 5 / 8 | 5 / 8 | 6 / 9 | 6 / 8 |
| serious Total, serious adverse events | 1 / 8 | 0 / 8 | 0 / 8 | 0 / 9 | 0 / 8 |
Outcome results
Accumulation Ratio of AUC (Racc(AUC))
Accumulation ratio for AUC, calculated as area under the serum concentration-time curve within one complete dosing interval at third dose divided by area under the serum concentration-time curve within one complete dosing interval at first dose.
Time frame: 0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336 hours post-first dose (Day 1) and 0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336, 504, 816, 1056, 1344 hours post-third dose (Day 29)
Population: PK analysis set included subjects who received active treatment (MSB0010841) without protocol deviations affecting PK, and who provide evaluable PK data. Here Number of participants analyzed signifies those subjects who were evaluable for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| MSB0010841 30 mg | Accumulation Ratio of AUC (Racc(AUC)) | 1.61 ratio | Geometric Coefficient of Variation 15.9 |
| MSB0010841 60 mg | Accumulation Ratio of AUC (Racc(AUC)) | 1.50 ratio | Geometric Coefficient of Variation 18.4 |
| MSB0010841 120 mg | Accumulation Ratio of AUC (Racc(AUC)) | 1.61 ratio | Geometric Coefficient of Variation 27.4 |
| MSB0010841 240 mg | Accumulation Ratio of AUC (Racc(AUC)) | 1.83 ratio | Geometric Coefficient of Variation 11.5 |
Accumulation Ratio of Cmax (Racc (Cmax))
Accumulation ratio for Cmax was calculated as Cmax, after third dose / Cmax, after first dose.
Time frame: 0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336 hours post-first dose (Day 1) and 0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336, 504, 816, 1056, 1344 hours post-third dose (Day 29)
Population: PK analysis set included subjects who received active treatment (MSB0010841) without protocol deviations affecting PK, and who provide evaluable PK data. Here Number of participants analyzed signifies those subjects who were evaluable for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| MSB0010841 30 mg | Accumulation Ratio of Cmax (Racc (Cmax)) | 1.56 ratio | Geometric Coefficient of Variation 17.9 |
| MSB0010841 60 mg | Accumulation Ratio of Cmax (Racc (Cmax)) | 1.52 ratio | Geometric Coefficient of Variation 23.5 |
| MSB0010841 120 mg | Accumulation Ratio of Cmax (Racc (Cmax)) | 1.56 ratio | Geometric Coefficient of Variation 34.1 |
| MSB0010841 240 mg | Accumulation Ratio of Cmax (Racc (Cmax)) | 1.81 ratio | Geometric Coefficient of Variation 9.5 |
Amount of Pain at Injection Site Assessed By Visual Analog Scale (VAS)
Subjects were asked to assess their severity of injection site pain on a 100 millimeter (mm) VAS, where 0 = no pain and 100 = worst possible pain. Mean of amount of pain was calculated for the subjects having a value \> 0. Maximum values per subjects (over injection site areas) are used for counting the amount of pain at injection site. Maximum pain scores recorded among all participants analysed in each arm are reported for each time point.
Time frame: Day 1, 2, 8, 15, 16, 22, 29, 30, 36, 43
Population: Safety analysis set included all 41 subjects who received at least one dose of IMP (MSB0010841 or placebo). Here Number of subjects analyzed signifies those subjects who were evaluable for this endpoint and n signifies those subjects who were evaluable at the specified time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MSB0010841 30 mg | Amount of Pain at Injection Site Assessed By Visual Analog Scale (VAS) | Day 43 (n=0,0,0,0,0) | NA mm |
| MSB0010841 30 mg | Amount of Pain at Injection Site Assessed By Visual Analog Scale (VAS) | Day 1 (n=3,2,3,2,0) | 7 mm |
| MSB0010841 30 mg | Amount of Pain at Injection Site Assessed By Visual Analog Scale (VAS) | Day 15 (n=2,1,3,0,0) | 5 mm |
| MSB0010841 30 mg | Amount of Pain at Injection Site Assessed By Visual Analog Scale (VAS) | Day 16 (n=0,0,0,0,2) | NA mm |
| MSB0010841 30 mg | Amount of Pain at Injection Site Assessed By Visual Analog Scale (VAS) | Day 22 (1,0,1,0,0) | 11 mm |
| MSB0010841 30 mg | Amount of Pain at Injection Site Assessed By Visual Analog Scale (VAS) | Day 8 (n=1,1,0,0,0) | 1 mm |
| MSB0010841 30 mg | Amount of Pain at Injection Site Assessed By Visual Analog Scale (VAS) | Day 29 (n=1,1,1,0,0) | 3 mm |
| MSB0010841 30 mg | Amount of Pain at Injection Site Assessed By Visual Analog Scale (VAS) | Day 36 (n=0,0,0,0,0) | NA mm |
| MSB0010841 30 mg | Amount of Pain at Injection Site Assessed By Visual Analog Scale (VAS) | Day 30 (1,0,1,1,0) | 2 mm |
| MSB0010841 30 mg | Amount of Pain at Injection Site Assessed By Visual Analog Scale (VAS) | Day 2 (n=1,1,1,1,0) | 1 mm |
| MSB0010841 60 mg | Amount of Pain at Injection Site Assessed By Visual Analog Scale (VAS) | Day 2 (n=1,1,1,1,0) | 1 mm |
| MSB0010841 60 mg | Amount of Pain at Injection Site Assessed By Visual Analog Scale (VAS) | Day 43 (n=0,0,0,0,0) | NA mm |
| MSB0010841 60 mg | Amount of Pain at Injection Site Assessed By Visual Analog Scale (VAS) | Day 29 (n=1,1,1,0,0) | 2 mm |
| MSB0010841 60 mg | Amount of Pain at Injection Site Assessed By Visual Analog Scale (VAS) | Day 8 (n=1,1,0,0,0) | 1 mm |
| MSB0010841 60 mg | Amount of Pain at Injection Site Assessed By Visual Analog Scale (VAS) | Day 1 (n=3,2,3,2,0) | 4 mm |
| MSB0010841 60 mg | Amount of Pain at Injection Site Assessed By Visual Analog Scale (VAS) | Day 15 (n=2,1,3,0,0) | 3 mm |
| MSB0010841 60 mg | Amount of Pain at Injection Site Assessed By Visual Analog Scale (VAS) | Day 22 (1,0,1,0,0) | NA mm |
| MSB0010841 60 mg | Amount of Pain at Injection Site Assessed By Visual Analog Scale (VAS) | Day 36 (n=0,0,0,0,0) | NA mm |
| MSB0010841 60 mg | Amount of Pain at Injection Site Assessed By Visual Analog Scale (VAS) | Day 16 (n=0,0,0,0,2) | NA mm |
| MSB0010841 60 mg | Amount of Pain at Injection Site Assessed By Visual Analog Scale (VAS) | Day 30 (1,0,1,1,0) | NA mm |
| MSB0010841 120 mg | Amount of Pain at Injection Site Assessed By Visual Analog Scale (VAS) | Day 30 (1,0,1,1,0) | 1 mm |
| MSB0010841 120 mg | Amount of Pain at Injection Site Assessed By Visual Analog Scale (VAS) | Day 16 (n=0,0,0,0,2) | NA mm |
| MSB0010841 120 mg | Amount of Pain at Injection Site Assessed By Visual Analog Scale (VAS) | Day 36 (n=0,0,0,0,0) | NA mm |
| MSB0010841 120 mg | Amount of Pain at Injection Site Assessed By Visual Analog Scale (VAS) | Day 43 (n=0,0,0,0,0) | NA mm |
| MSB0010841 120 mg | Amount of Pain at Injection Site Assessed By Visual Analog Scale (VAS) | Day 2 (n=1,1,1,1,0) | 1 mm |
| MSB0010841 120 mg | Amount of Pain at Injection Site Assessed By Visual Analog Scale (VAS) | Day 1 (n=3,2,3,2,0) | 7 mm |
| MSB0010841 120 mg | Amount of Pain at Injection Site Assessed By Visual Analog Scale (VAS) | Day 8 (n=1,1,0,0,0) | NA mm |
| MSB0010841 120 mg | Amount of Pain at Injection Site Assessed By Visual Analog Scale (VAS) | Day 15 (n=2,1,3,0,0) | 7 mm |
| MSB0010841 120 mg | Amount of Pain at Injection Site Assessed By Visual Analog Scale (VAS) | Day 22 (1,0,1,0,0) | 1 mm |
| MSB0010841 120 mg | Amount of Pain at Injection Site Assessed By Visual Analog Scale (VAS) | Day 29 (n=1,1,1,0,0) | 2 mm |
| MSB0010841 240 mg | Amount of Pain at Injection Site Assessed By Visual Analog Scale (VAS) | Day 1 (n=3,2,3,2,0) | 4 mm |
| MSB0010841 240 mg | Amount of Pain at Injection Site Assessed By Visual Analog Scale (VAS) | Day 30 (1,0,1,1,0) | 1 mm |
| MSB0010841 240 mg | Amount of Pain at Injection Site Assessed By Visual Analog Scale (VAS) | Day 2 (n=1,1,1,1,0) | 1 mm |
| MSB0010841 240 mg | Amount of Pain at Injection Site Assessed By Visual Analog Scale (VAS) | Day 8 (n=1,1,0,0,0) | NA mm |
| MSB0010841 240 mg | Amount of Pain at Injection Site Assessed By Visual Analog Scale (VAS) | Day 15 (n=2,1,3,0,0) | NA mm |
| MSB0010841 240 mg | Amount of Pain at Injection Site Assessed By Visual Analog Scale (VAS) | Day 16 (n=0,0,0,0,2) | NA mm |
| MSB0010841 240 mg | Amount of Pain at Injection Site Assessed By Visual Analog Scale (VAS) | Day 22 (1,0,1,0,0) | NA mm |
| MSB0010841 240 mg | Amount of Pain at Injection Site Assessed By Visual Analog Scale (VAS) | Day 43 (n=0,0,0,0,0) | NA mm |
| MSB0010841 240 mg | Amount of Pain at Injection Site Assessed By Visual Analog Scale (VAS) | Day 29 (n=1,1,1,0,0) | NA mm |
| MSB0010841 240 mg | Amount of Pain at Injection Site Assessed By Visual Analog Scale (VAS) | Day 36 (n=0,0,0,0,0) | NA mm |
| Placebo | Amount of Pain at Injection Site Assessed By Visual Analog Scale (VAS) | Day 36 (n=0,0,0,0,0) | NA mm |
| Placebo | Amount of Pain at Injection Site Assessed By Visual Analog Scale (VAS) | Day 15 (n=2,1,3,0,0) | NA mm |
| Placebo | Amount of Pain at Injection Site Assessed By Visual Analog Scale (VAS) | Day 2 (n=1,1,1,1,0) | NA mm |
| Placebo | Amount of Pain at Injection Site Assessed By Visual Analog Scale (VAS) | Day 30 (1,0,1,1,0) | NA mm |
| Placebo | Amount of Pain at Injection Site Assessed By Visual Analog Scale (VAS) | Day 22 (1,0,1,0,0) | NA mm |
| Placebo | Amount of Pain at Injection Site Assessed By Visual Analog Scale (VAS) | Day 29 (n=1,1,1,0,0) | NA mm |
| Placebo | Amount of Pain at Injection Site Assessed By Visual Analog Scale (VAS) | Day 8 (n=1,1,0,0,0) | NA mm |
| Placebo | Amount of Pain at Injection Site Assessed By Visual Analog Scale (VAS) | Day 43 (n=0,0,0,0,0) | NA mm |
| Placebo | Amount of Pain at Injection Site Assessed By Visual Analog Scale (VAS) | Day 1 (n=3,2,3,2,0) | NA mm |
| Placebo | Amount of Pain at Injection Site Assessed By Visual Analog Scale (VAS) | Day 16 (n=0,0,0,0,2) | 2 mm |
Apparent Clearance (CL/f) Post Third Dose of MSB0010841
Clearance of a drug was a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Apparent clearance after oral dose (CL/f) is influenced by the fraction absorbed.
Time frame: 0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336, 504, 816, 1056, 1344 hours post-third dose (Day 29)
Population: PK analysis set included subjects who received active treatment (MSB0010841) without protocol deviations affecting PK, and who provide evaluable PK data. Here Number of participants analyzed signifies those subjects who were evaluable for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| MSB0010841 30 mg | Apparent Clearance (CL/f) Post Third Dose of MSB0010841 | 0.55 L/day | Geometric Coefficient of Variation 36.3 |
| MSB0010841 60 mg | Apparent Clearance (CL/f) Post Third Dose of MSB0010841 | 0.58 L/day | Geometric Coefficient of Variation 33.9 |
| MSB0010841 120 mg | Apparent Clearance (CL/f) Post Third Dose of MSB0010841 | 0.59 L/day | Geometric Coefficient of Variation 43.6 |
| MSB0010841 240 mg | Apparent Clearance (CL/f) Post Third Dose of MSB0010841 | 0.60 L/day | Geometric Coefficient of Variation 27.1 |
Apparent Terminal Half-life (t1/2) Post Third Dose of MSB0010841
Terminal half-life is the time measured for the concentration to decrease by one half. Terminal half-life is calculated by dividing the natural logarithm to the base e (Log e) multiplied by (\*) 2/ λz, where 'λz' is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.
Time frame: 0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336, 504, 816, 1056, 1344 hours post-third dose (Day 29)
Population: PK analysis set included subjects who received active treatment (MSB0010841) without protocol deviations affecting PK, and who provide evaluable PK data. Here Number of participants analyzed signifies those subjects who were evaluable for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| MSB0010841 30 mg | Apparent Terminal Half-life (t1/2) Post Third Dose of MSB0010841 | 10.63 day | Geometric Coefficient of Variation 17.3 |
| MSB0010841 60 mg | Apparent Terminal Half-life (t1/2) Post Third Dose of MSB0010841 | 10.50 day | Geometric Coefficient of Variation 18.9 |
| MSB0010841 120 mg | Apparent Terminal Half-life (t1/2) Post Third Dose of MSB0010841 | 12.19 day | Geometric Coefficient of Variation 27.9 |
| MSB0010841 240 mg | Apparent Terminal Half-life (t1/2) Post Third Dose of MSB0010841 | 10.25 day | Geometric Coefficient of Variation 13.1 |
Apparent Volume of Distribution During Terminal Phase (Vz/f) Post Third Dose of MSB0010841
Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired serum concentration of a drug. Apparent volume of distribution during the terminal phase, calculated as Vz = Dose/AUC0-inf multiplied by elimination rate constant \[λz\]) following first dose and Dose/(AUCtau multiplied by λz) after third dose.
Time frame: 0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336, 504, 816, 1056, 1344 hours post-third dose (Day 29)
Population: PK analysis set included subjects who received active treatment (MSB0010841) without protocol deviations affecting PK, and who provide evaluable PK data. Here Number of subjects analyzed signifies those subjects who were evaluable for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| MSB0010841 30 mg | Apparent Volume of Distribution During Terminal Phase (Vz/f) Post Third Dose of MSB0010841 | 8.49 Liters | Geometric Coefficient of Variation 27 |
| MSB0010841 60 mg | Apparent Volume of Distribution During Terminal Phase (Vz/f) Post Third Dose of MSB0010841 | 8.73 Liters | Geometric Coefficient of Variation 38.6 |
| MSB0010841 120 mg | Apparent Volume of Distribution During Terminal Phase (Vz/f) Post Third Dose of MSB0010841 | 10.39 Liters | Geometric Coefficient of Variation 21.9 |
| MSB0010841 240 mg | Apparent Volume of Distribution During Terminal Phase (Vz/f) Post Third Dose of MSB0010841 | 8.92 Liters | Geometric Coefficient of Variation 18.8 |
Area Under the Concentration-time Curve From Time Zero to Infinity (AUC 0-inf) Post Third Dose of MSB0010841
Area under the serum concentration-time curve from time zero to infinity (AUC0-inf). AUC0-infcalculated as AUC0-t + AUCextra. AUCextra represents the extrapolated part of AUC0-inf calculated by Clast calc/λz, where Clast calc is the calculated concentration at the last sampling time point at which the measured concentration is at or above LLOQ and λz is the terminal rate constant determined from the terminal slope of the log transformed concentration curve using linear regression on terminal data points of the curve.
Time frame: 0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336, 504, 816, 1056, 1344 hours post-third dose (Day 29)
Population: PK analysis set included subjects who received active treatment (MSB0010841) without protocol deviations affecting PK, and who provide evaluable PK data. Here Number of participants analyzed signifies those subjects who were evaluable for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| MSB0010841 30 mg | Area Under the Concentration-time Curve From Time Zero to Infinity (AUC 0-inf) Post Third Dose of MSB0010841 | 97.6 day*ug/mL | Geometric Coefficient of Variation 42.2 |
| MSB0010841 60 mg | Area Under the Concentration-time Curve From Time Zero to Infinity (AUC 0-inf) Post Third Dose of MSB0010841 | 174.9 day*ug/mL | Geometric Coefficient of Variation 39.9 |
| MSB0010841 120 mg | Area Under the Concentration-time Curve From Time Zero to Infinity (AUC 0-inf) Post Third Dose of MSB0010841 | 392.6 day*ug/mL | Geometric Coefficient of Variation 68.8 |
| MSB0010841 240 mg | Area Under the Concentration-time Curve From Time Zero to Infinity (AUC 0-inf) Post Third Dose of MSB0010841 | 680.9 day*ug/mL | Geometric Coefficient of Variation 32.2 |
Area Under the Concentration-Time Curve From Time Zero up to Time Tau (AUCtau) Post First Dose of MSB0010841
Area under the concentration-time curve from time zero up to time Tau, where Tau is the dosing interval (336 hours).
Time frame: 0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336 hours post-first dose (Day 1)
Population: PK analysis set included subjects who received active treatment (MSB0010841) without protocol deviations affecting PK, and who provide evaluable PK data. Here Number of participants analyzed signifies those subjects who were evaluable for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| MSB0010841 30 mg | Area Under the Concentration-Time Curve From Time Zero up to Time Tau (AUCtau) Post First Dose of MSB0010841 | 32.4 day*mcg/mL | Geometric Coefficient of Variation 31.2 |
| MSB0010841 60 mg | Area Under the Concentration-Time Curve From Time Zero up to Time Tau (AUCtau) Post First Dose of MSB0010841 | 68.3 day*mcg/mL | Geometric Coefficient of Variation 16.4 |
| MSB0010841 120 mg | Area Under the Concentration-Time Curve From Time Zero up to Time Tau (AUCtau) Post First Dose of MSB0010841 | 114.6 day*mcg/mL | Geometric Coefficient of Variation 24.2 |
| MSB0010841 240 mg | Area Under the Concentration-Time Curve From Time Zero up to Time Tau (AUCtau) Post First Dose of MSB0010841 | 222.2 day*mcg/mL | Geometric Coefficient of Variation 19.6 |
Area Under the Concentration-Time Curve From Time Zero up to Time Tau (AUCtau) Post Third Dose of MSB0010841
Area under the concentration-time curve from time zero up to time Tau, where Tau is the dosing interval (336 hours).
Time frame: 0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336 hours post-third dose (Day 29)
Population: PK analysis set included subjects who received active treatment (MSB0010841) without protocol deviations affecting PK, and who provide evaluable PK data. Here Number of participants analyzed signifies those subjects who were evaluable for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| MSB0010841 30 mg | Area Under the Concentration-Time Curve From Time Zero up to Time Tau (AUCtau) Post Third Dose of MSB0010841 | 54.2 day*mcg/mL | Geometric Coefficient of Variation 36.3 |
| MSB0010841 60 mg | Area Under the Concentration-Time Curve From Time Zero up to Time Tau (AUCtau) Post Third Dose of MSB0010841 | 104.1 day*mcg/mL | Geometric Coefficient of Variation 33.9 |
| MSB0010841 120 mg | Area Under the Concentration-Time Curve From Time Zero up to Time Tau (AUCtau) Post Third Dose of MSB0010841 | 203.2 day*mcg/mL | Geometric Coefficient of Variation 43.6 |
| MSB0010841 240 mg | Area Under the Concentration-Time Curve From Time Zero up to Time Tau (AUCtau) Post Third Dose of MSB0010841 | 397.6 day*mcg/mL | Geometric Coefficient of Variation 27.1 |
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUC0-t) Post First Dose of MSB0010841
Area under the serum concentration-time curve (AUC) from time zero to the last sampling time point at which the concentration is at or above lower limit of quantification (LLOQ).
Time frame: 0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336 hours post-first dose (Day 1)
Population: PK analysis set included subjects who received active treatment (MSB0010841) without protocol deviations affecting PK, and who provide evaluable PK data. Here Number of participants analyzed signifies those subjects who were evaluable for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| MSB0010841 30 mg | Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUC0-t) Post First Dose of MSB0010841 | 33.6 day*microgram per milliliter (day*mcg/mL | Geometric Coefficient of Variation 28 |
| MSB0010841 60 mg | Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUC0-t) Post First Dose of MSB0010841 | 69.3 day*microgram per milliliter (day*mcg/mL | Geometric Coefficient of Variation 18.9 |
| MSB0010841 120 mg | Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUC0-t) Post First Dose of MSB0010841 | 126.3 day*microgram per milliliter (day*mcg/mL | Geometric Coefficient of Variation 28.5 |
| MSB0010841 240 mg | Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUC0-t) Post First Dose of MSB0010841 | 216.5 day*microgram per milliliter (day*mcg/mL | Geometric Coefficient of Variation 23.4 |
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUC0-t) Post Third Dose of MSB0010841
Area under the serum concentration-time curve (AUC) from time zero to the last sampling time point at which the concentration is at or above LLOQ.
Time frame: 0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336, 504, 816, 1056, 1344 hours post-third dose (Day 29)
Population: PK analysis set included subjects who received active treatment (MSB0010841) without protocol deviations affecting PK, and who provide evaluable PK data. Here Number of participants analyzed signifies those subjects who were evaluable for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| MSB0010841 30 mg | Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUC0-t) Post Third Dose of MSB0010841 | 93.7 day*mcg/mL | Geometric Coefficient of Variation 41.4 |
| MSB0010841 60 mg | Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUC0-t) Post Third Dose of MSB0010841 | 170.3 day*mcg/mL | Geometric Coefficient of Variation 39.5 |
| MSB0010841 120 mg | Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUC0-t) Post Third Dose of MSB0010841 | 371.7 day*mcg/mL | Geometric Coefficient of Variation 62 |
| MSB0010841 240 mg | Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUC0-t) Post Third Dose of MSB0010841 | 663.4 day*mcg/mL | Geometric Coefficient of Variation 31.1 |
Average Concentration (Cav) Post First Dose of MSB0010841
Cav was calculated by AUCtau/tau. Where tau is the dosing interval (336 hours).
Time frame: 0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336 hours post-first dose (Day 1)
Population: PK analysis set included subjects who received active treatment (MSB0010841) without protocol deviations affecting PK, and who provide evaluable PK data. Here Number of participants analyzed signifies those subjects who were evaluable for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| MSB0010841 30 mg | Average Concentration (Cav) Post First Dose of MSB0010841 | 2.315 mcg/mL | Geometric Coefficient of Variation 31.2 |
| MSB0010841 60 mg | Average Concentration (Cav) Post First Dose of MSB0010841 | 4.881 mcg/mL | Geometric Coefficient of Variation 16.4 |
| MSB0010841 120 mg | Average Concentration (Cav) Post First Dose of MSB0010841 | 8.187 mcg/mL | Geometric Coefficient of Variation 24.2 |
| MSB0010841 240 mg | Average Concentration (Cav) Post First Dose of MSB0010841 | 15.868 mcg/mL | Geometric Coefficient of Variation 19.6 |
Average Concentration (Cav) Post Third Dose of MSB0010841
Cav was calculated by AUCtau/tau. Where tau is the dosing interval (336 hours).
Time frame: 0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336, 504, 816, 1056, 1344 hours post-third dose (Day 29)
Population: PK analysis set included subjects who received active treatment (MSB0010841) without protocol deviations affecting PK, and who provide evaluable PK data. Here Number of participants analyzed signifies those subjects who were evaluable for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| MSB0010841 30 mg | Average Concentration (Cav) Post Third Dose of MSB0010841 | 3.87 mcg/mL | Geometric Coefficient of Variation 36.3 |
| MSB0010841 60 mg | Average Concentration (Cav) Post Third Dose of MSB0010841 | 7.44 mcg/mL | Geometric Coefficient of Variation 33.9 |
| MSB0010841 120 mg | Average Concentration (Cav) Post Third Dose of MSB0010841 | 14.51 mcg/mL | Geometric Coefficient of Variation 43.6 |
| MSB0010841 240 mg | Average Concentration (Cav) Post Third Dose of MSB0010841 | 28.40 mcg/mL | Geometric Coefficient of Variation 27.1 |
Levels of Anti-MSB0010841 Antibody Titers
Time frame: Day 8, 15 (pre-dose), 22, 29 (pre-dose), 36, 43, 63 and 85
Population: All subjects who received placebo or MSB0010841 (30 mg, 60 mg, 90 mg or 240 mg) and had positive ADA titers before and/or after study drug administration were included in the analysis population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MSB0010841 30 mg | Levels of Anti-MSB0010841 Antibody Titers | Day 36 Subject 11: MSB0010841 120 mg | 4.38 log10titer |
| MSB0010841 30 mg | Levels of Anti-MSB0010841 Antibody Titers | Day 36 Subject 12: MSB0010841 120 mg | 3.68 log10titer |
| MSB0010841 30 mg | Levels of Anti-MSB0010841 Antibody Titers | Day 36 Subject 13: MSB0010841 240 mg | 2.98 log10titer |
| MSB0010841 30 mg | Levels of Anti-MSB0010841 Antibody Titers | Day 43 Subject 1: Placebo | 2.98 log10titer |
| MSB0010841 30 mg | Levels of Anti-MSB0010841 Antibody Titers | Day 43 Subject 2: Placebo | 3.68 log10titer |
| MSB0010841 30 mg | Levels of Anti-MSB0010841 Antibody Titers | Day 43 Subject 8: MSB0010841 120 mg | 4.38 log10titer |
| MSB0010841 30 mg | Levels of Anti-MSB0010841 Antibody Titers | Day 43 Subject 9: MSB0010841 120 mg | 3.68 log10titer |
| MSB0010841 30 mg | Levels of Anti-MSB0010841 Antibody Titers | Day 43 Subject 10: MSB0010841 120 mg | 4.38 log10titer |
| MSB0010841 30 mg | Levels of Anti-MSB0010841 Antibody Titers | Day 43 Subject 11: MSB0010841 120 mg | 3.68 log10titer |
| MSB0010841 30 mg | Levels of Anti-MSB0010841 Antibody Titers | Day 8 Subject 1: Placebo | 3.68 log10titer |
| MSB0010841 30 mg | Levels of Anti-MSB0010841 Antibody Titers | Day 8 Subject 2: Placebo | 3.68 log10titer |
| MSB0010841 30 mg | Levels of Anti-MSB0010841 Antibody Titers | Day 8 Subject 3: Placebo | 3.68 log10titer |
| MSB0010841 30 mg | Levels of Anti-MSB0010841 Antibody Titers | Day 8 Subject 4: MSB0010841 30 mg | 3.68 log10titer |
| MSB0010841 30 mg | Levels of Anti-MSB0010841 Antibody Titers | Day 8 Subject 5: MSB0010841 30 mg | 0 log10titer |
| MSB0010841 30 mg | Levels of Anti-MSB0010841 Antibody Titers | Day 8 Subject 6: MSB0010841 30 mg | 2.28 log10titer |
| MSB0010841 30 mg | Levels of Anti-MSB0010841 Antibody Titers | Day 8 Subject 7: MSB0010841 60 mg | 0 log10titer |
| MSB0010841 30 mg | Levels of Anti-MSB0010841 Antibody Titers | Day 8 Subject 8: MSB0010841 120 mg | 3.68 log10titer |
| MSB0010841 30 mg | Levels of Anti-MSB0010841 Antibody Titers | Day 8 Subject 9: MSB0010841 120 mg | 4.38 log10titer |
| MSB0010841 30 mg | Levels of Anti-MSB0010841 Antibody Titers | Day 8 Subject 10: MSB0010841 120 mg | 3.68 log10titer |
| MSB0010841 30 mg | Levels of Anti-MSB0010841 Antibody Titers | Day 8 Subject 11: MSB0010841 120 mg | 4.38 log10titer |
| MSB0010841 30 mg | Levels of Anti-MSB0010841 Antibody Titers | Day 8 Subject 12: MSB0010841 120 mg | 2.98 log10titer |
| MSB0010841 30 mg | Levels of Anti-MSB0010841 Antibody Titers | Day 8 Subject 13: MSB0010841 240 mg | 2.98 log10titer |
| MSB0010841 30 mg | Levels of Anti-MSB0010841 Antibody Titers | Day 15 (pre-dose) Subject 1: Placebo | 3.68 log10titer |
| MSB0010841 30 mg | Levels of Anti-MSB0010841 Antibody Titers | Day 15 (pre-dose) Subject 2: Placebo | 3.68 log10titer |
| MSB0010841 30 mg | Levels of Anti-MSB0010841 Antibody Titers | Day 15 (pre-dose) Subject 3: Placebo | 3.68 log10titer |
| MSB0010841 30 mg | Levels of Anti-MSB0010841 Antibody Titers | Day 15 (pre-dose) Subject 4: MSB0010841 30 mg | 3.68 log10titer |
| MSB0010841 30 mg | Levels of Anti-MSB0010841 Antibody Titers | Day 15 (pre-dose) Subject 5: MSB0010841 30 mg | 0 log10titer |
| MSB0010841 30 mg | Levels of Anti-MSB0010841 Antibody Titers | Day 15 (pre-dose) Subject 6: MSB0010841 30 mg | 2.28 log10titer |
| MSB0010841 30 mg | Levels of Anti-MSB0010841 Antibody Titers | Day 15 (pre-dose) Subject 7: MSB0010841 60 mg | 2.98 log10titer |
| MSB0010841 30 mg | Levels of Anti-MSB0010841 Antibody Titers | Day 15 (pre-dose) Subject 8: MSB0010841 120 mg | 5.78 log10titer |
| MSB0010841 30 mg | Levels of Anti-MSB0010841 Antibody Titers | Day 15 (pre-dose) Subject 9: MSB0010841 120 mg | 4.38 log10titer |
| MSB0010841 30 mg | Levels of Anti-MSB0010841 Antibody Titers | Day 15 (pre-dose) Subject 10: MSB0010841 120 mg | 3.68 log10titer |
| MSB0010841 30 mg | Levels of Anti-MSB0010841 Antibody Titers | Day 15 (pre-dose) Subject 11: MSB0010841 120 mg | 4.38 log10titer |
| MSB0010841 30 mg | Levels of Anti-MSB0010841 Antibody Titers | Day 15 (pre-dose) Subject 12: MSB0010841 120 mg | 2.98 log10titer |
| MSB0010841 30 mg | Levels of Anti-MSB0010841 Antibody Titers | Day 15 (pre-dose) Subject 13: MSB0010841 240 mg | 2.98 log10titer |
| MSB0010841 30 mg | Levels of Anti-MSB0010841 Antibody Titers | Day 22 Subject 1: Placebo | 3.68 log10titer |
| MSB0010841 30 mg | Levels of Anti-MSB0010841 Antibody Titers | Day 22 Subject 2: Placebo | 3.68 log10titer |
| MSB0010841 30 mg | Levels of Anti-MSB0010841 Antibody Titers | Day 22 Subject 3: Placebo | 3.68 log10titer |
| MSB0010841 30 mg | Levels of Anti-MSB0010841 Antibody Titers | Day 22 Subject 4: MSB0010841 30 mg | 3.68 log10titer |
| MSB0010841 30 mg | Levels of Anti-MSB0010841 Antibody Titers | Day 22 Subject 5: MSB0010841 30 mg | 2.98 log10titer |
| MSB0010841 30 mg | Levels of Anti-MSB0010841 Antibody Titers | Day 22 Subject 6: MSB0010841 30 mg | 2.98 log10titer |
| MSB0010841 30 mg | Levels of Anti-MSB0010841 Antibody Titers | Day 22 Subject 7: MSB0010841 60 mg | 2.28 log10titer |
| MSB0010841 30 mg | Levels of Anti-MSB0010841 Antibody Titers | Day 22 Subject 8: MSB0010841 120 mg | 2.98 log10titer |
| MSB0010841 30 mg | Levels of Anti-MSB0010841 Antibody Titers | Day 22 Subject 9: MSB0010841 120 mg | 4.38 log10titer |
| MSB0010841 30 mg | Levels of Anti-MSB0010841 Antibody Titers | Day 22 Subject 10: MSB0010841 120 mg | 3.68 log10titer |
| MSB0010841 30 mg | Levels of Anti-MSB0010841 Antibody Titers | Day 22 Subject 11: MSB0010841 120 mg | 4.38 log10titer |
| MSB0010841 30 mg | Levels of Anti-MSB0010841 Antibody Titers | Day 22 Subject 12: MSB0010841 120 mg | 2.98 log10titer |
| MSB0010841 30 mg | Levels of Anti-MSB0010841 Antibody Titers | Day 22 Subject 13: MSB0010841 240 mg | 2.98 log10titer |
| MSB0010841 30 mg | Levels of Anti-MSB0010841 Antibody Titers | Day 29 (pre-dose) Subject 1: Placebo | 3.68 log10titer |
| MSB0010841 30 mg | Levels of Anti-MSB0010841 Antibody Titers | Day 29 (pre-dose) Subject 2: Placebo | 3.68 log10titer |
| MSB0010841 30 mg | Levels of Anti-MSB0010841 Antibody Titers | Day 29 (pre-dose) Subject 3: Placebo | 3.68 log10titer |
| MSB0010841 30 mg | Levels of Anti-MSB0010841 Antibody Titers | Day 29 (pre-dose) Subject 4: MSB0010841 30 mg | 2.98 log10titer |
| MSB0010841 30 mg | Levels of Anti-MSB0010841 Antibody Titers | Day 29 (pre-dose) Subject 5: MSB0010841 30 mg | 0 log10titer |
| MSB0010841 30 mg | Levels of Anti-MSB0010841 Antibody Titers | Day 29 (pre-dose) Subject 6: MSB0010841 30 mg | 2.98 log10titer |
| MSB0010841 30 mg | Levels of Anti-MSB0010841 Antibody Titers | Day 29 (pre-dose) Subject 7: MSB0010841 60 mg | 2.28 log10titer |
| MSB0010841 30 mg | Levels of Anti-MSB0010841 Antibody Titers | Day 29 (pre-dose) Subject 8: MSB0010841 120 mg | 3.68 log10titer |
| MSB0010841 30 mg | Levels of Anti-MSB0010841 Antibody Titers | Day 29 (pre-dose) Subject 9: MSB0010841 120 mg | 3.68 log10titer |
| MSB0010841 30 mg | Levels of Anti-MSB0010841 Antibody Titers | Day 29 (pre-dose) Subject 10: MSB0010841 120 mg | 3.68 log10titer |
| MSB0010841 30 mg | Levels of Anti-MSB0010841 Antibody Titers | Day 29 (pre-dose) Subject 11: MSB0010841 120 mg | 4.38 log10titer |
| MSB0010841 30 mg | Levels of Anti-MSB0010841 Antibody Titers | Day 29 (pre-dose) Subject 12: MSB0010841 120 mg | 2.98 log10titer |
| MSB0010841 30 mg | Levels of Anti-MSB0010841 Antibody Titers | Day 29 (pre-dose) Subject 13: MSB0010841 240 mg | 2.98 log10titer |
| MSB0010841 30 mg | Levels of Anti-MSB0010841 Antibody Titers | Day 36 Subject 1: Placebo | NA log10titer |
| MSB0010841 30 mg | Levels of Anti-MSB0010841 Antibody Titers | Day 36 Subject 2: Placebo | 3.68 log10titer |
| MSB0010841 30 mg | Levels of Anti-MSB0010841 Antibody Titers | Day 36 Subject 3: Placebo | 3.68 log10titer |
| MSB0010841 30 mg | Levels of Anti-MSB0010841 Antibody Titers | Day 36 Subject 4: MSB0010841 30 mg | 2.98 log10titer |
| MSB0010841 30 mg | Levels of Anti-MSB0010841 Antibody Titers | Day 36 Subject 5: MSB0010841 30 mg | 0 log10titer |
| MSB0010841 30 mg | Levels of Anti-MSB0010841 Antibody Titers | Day 36 Subject 6: MSB0010841 30 mg | 2.98 log10titer |
| MSB0010841 30 mg | Levels of Anti-MSB0010841 Antibody Titers | Day 36 Subject 7: MSB0010841 60 mg | 2.98 log10titer |
| MSB0010841 30 mg | Levels of Anti-MSB0010841 Antibody Titers | Day 36 Subject 8: MSB0010841 120 mg | NA log10titer |
| MSB0010841 30 mg | Levels of Anti-MSB0010841 Antibody Titers | Day 36 Subject 9: MSB0010841 120 mg | 3.68 log10titer |
| MSB0010841 30 mg | Levels of Anti-MSB0010841 Antibody Titers | Day 36 Subject 10: MSB0010841 120 mg | 4.38 log10titer |
| MSB0010841 30 mg | Levels of Anti-MSB0010841 Antibody Titers | Day 43 Subject 3: Placebo | 3.68 log10titer |
| MSB0010841 30 mg | Levels of Anti-MSB0010841 Antibody Titers | Day 43 Subject 4: MSB0010841 30 mg | 2.98 log10titer |
| MSB0010841 30 mg | Levels of Anti-MSB0010841 Antibody Titers | Day 43 Subject 5: MSB0010841 30 mg | 0 log10titer |
| MSB0010841 30 mg | Levels of Anti-MSB0010841 Antibody Titers | Day 43 Subject 6: MSB0010841 30 mg | 2.98 log10titer |
| MSB0010841 30 mg | Levels of Anti-MSB0010841 Antibody Titers | Day 43 Subject 7: MSB0010841 60 mg | 2.28 log10titer |
| MSB0010841 30 mg | Levels of Anti-MSB0010841 Antibody Titers | Day 43 Subject 12: MSB0010841 120 mg | 2.98 log10titer |
| MSB0010841 30 mg | Levels of Anti-MSB0010841 Antibody Titers | Day 43 Subject 13: MSB0010841 240 mg | 2.98 log10titer |
| MSB0010841 30 mg | Levels of Anti-MSB0010841 Antibody Titers | Day 63 Subject 1: Placebo | 3.68 log10titer |
| MSB0010841 30 mg | Levels of Anti-MSB0010841 Antibody Titers | Day 63 Subject 2: Placebo | 3.68 log10titer |
| MSB0010841 30 mg | Levels of Anti-MSB0010841 Antibody Titers | Day 63 Subject 3: Placebo | 3.68 log10titer |
| MSB0010841 30 mg | Levels of Anti-MSB0010841 Antibody Titers | Day 63 Subject 4: MSB0010841 30 mg | 4.38 log10titer |
| MSB0010841 30 mg | Levels of Anti-MSB0010841 Antibody Titers | Day 63 Subject 5: MSB0010841 30 mg | 0 log10titer |
| MSB0010841 30 mg | Levels of Anti-MSB0010841 Antibody Titers | Day 63 Subject 6: MSB0010841 30 mg | 2.98 log10titer |
| MSB0010841 30 mg | Levels of Anti-MSB0010841 Antibody Titers | Day 63 Subject 7: MSB0010841 60 mg | 2.28 log10titer |
| MSB0010841 30 mg | Levels of Anti-MSB0010841 Antibody Titers | Day 63 Subject 8: MSB0010841 120 mg | 2.98 log10titer |
| MSB0010841 30 mg | Levels of Anti-MSB0010841 Antibody Titers | Day 63 Subject 9: MSB0010841 120 mg | 3.68 log10titer |
| MSB0010841 30 mg | Levels of Anti-MSB0010841 Antibody Titers | Day 63 Subject 10: MSB0010841 120 mg | 3.68 log10titer |
| MSB0010841 30 mg | Levels of Anti-MSB0010841 Antibody Titers | Day 63 Subject 11: MSB0010841 120 mg | 3.68 log10titer |
| MSB0010841 30 mg | Levels of Anti-MSB0010841 Antibody Titers | Day 63 Subject 12: MSB0010841 120 mg | 3.68 log10titer |
| MSB0010841 30 mg | Levels of Anti-MSB0010841 Antibody Titers | Day 63 Subject 13: MSB0010841 240 mg | 2.98 log10titer |
| MSB0010841 30 mg | Levels of Anti-MSB0010841 Antibody Titers | Day 85 Subject 1: Placebo | 3.68 log10titer |
| MSB0010841 30 mg | Levels of Anti-MSB0010841 Antibody Titers | Day 85 Subject 2: Placebo | 3.68 log10titer |
| MSB0010841 30 mg | Levels of Anti-MSB0010841 Antibody Titers | Day 85 Subject 3: Placebo | 3.68 log10titer |
| MSB0010841 30 mg | Levels of Anti-MSB0010841 Antibody Titers | Day 85 Subject 4: MSB0010841 30 mg | 3.68 log10titer |
| MSB0010841 30 mg | Levels of Anti-MSB0010841 Antibody Titers | Day 85 Subject 5: MSB0010841 30 mg | 0 log10titer |
| MSB0010841 30 mg | Levels of Anti-MSB0010841 Antibody Titers | Day 85 Subject 6: MSB0010841 30 mg | 2.28 log10titer |
| MSB0010841 30 mg | Levels of Anti-MSB0010841 Antibody Titers | Day 85 Subject 7: MSB0010841 60 mg | 2.28 log10titer |
| MSB0010841 30 mg | Levels of Anti-MSB0010841 Antibody Titers | Day 85 Subject 8: MSB0010841 120 mg | 2.98 log10titer |
| MSB0010841 30 mg | Levels of Anti-MSB0010841 Antibody Titers | Day 85 Subject 9: MSB0010841 120 mg | 3.68 log10titer |
| MSB0010841 30 mg | Levels of Anti-MSB0010841 Antibody Titers | Day 85 Subject 10: MSB0010841 120 mg | 3.68 log10titer |
| MSB0010841 30 mg | Levels of Anti-MSB0010841 Antibody Titers | Day 85 Subject 11: MSB0010841 120 mg | 2.98 log10titer |
| MSB0010841 30 mg | Levels of Anti-MSB0010841 Antibody Titers | Day 85 Subject 12: MSB0010841 120 mg | 3.68 log10titer |
| MSB0010841 30 mg | Levels of Anti-MSB0010841 Antibody Titers | Day 85 Subject 13: MSB0010841 240 mg | 2.98 log10titer |
Levels of Pre-existing Anti-MSB0010841 Antibody Titers
Time frame: Pre-dose on Day 1
Population: All subjects who received placebo or MSB0010841 (30 mg, 60 mg, 90 mg or 240 mg) and had positive ADA titers before and/or after study drug administration were included in the analysis population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MSB0010841 30 mg | Levels of Pre-existing Anti-MSB0010841 Antibody Titers | Subject 1: Placebo | 2.98 log10titer |
| MSB0010841 30 mg | Levels of Pre-existing Anti-MSB0010841 Antibody Titers | Subject 2: Placebo | 3.68 log10titer |
| MSB0010841 30 mg | Levels of Pre-existing Anti-MSB0010841 Antibody Titers | Subject 3: Placebo | 3.68 log10titer |
| MSB0010841 30 mg | Levels of Pre-existing Anti-MSB0010841 Antibody Titers | Subject 4: MSB0010841 30 mg | 2.98 log10titer |
| MSB0010841 30 mg | Levels of Pre-existing Anti-MSB0010841 Antibody Titers | Subject 5: MSB0010841 30 mg | 0 log10titer |
| MSB0010841 30 mg | Levels of Pre-existing Anti-MSB0010841 Antibody Titers | Subject 6: MSB0010841 30 mg | 0 log10titer |
| MSB0010841 30 mg | Levels of Pre-existing Anti-MSB0010841 Antibody Titers | Subject 7: MSB0010841 60 mg | 0 log10titer |
| MSB0010841 30 mg | Levels of Pre-existing Anti-MSB0010841 Antibody Titers | Subject 8: MSB0010841 120 mg | 2.98 log10titer |
| MSB0010841 30 mg | Levels of Pre-existing Anti-MSB0010841 Antibody Titers | Subject 9: MSB0010841 120 mg | 5.08 log10titer |
| MSB0010841 30 mg | Levels of Pre-existing Anti-MSB0010841 Antibody Titers | Subject 10: MSB0010841 120 mg | 3.68 log10titer |
| MSB0010841 30 mg | Levels of Pre-existing Anti-MSB0010841 Antibody Titers | Subject 11: MSB0010841 120 mg | 3.68 log10titer |
| MSB0010841 30 mg | Levels of Pre-existing Anti-MSB0010841 Antibody Titers | Subject 12: MSB0010841 120 mg | 2.98 log10titer |
| MSB0010841 30 mg | Levels of Pre-existing Anti-MSB0010841 Antibody Titers | Subject 13: MSB0010841 240 mg | 0 log10titer |
Maximum Concentration Observed (Cmax) Post First Dose of MSB0010841
Time frame: 0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336 hours post-first dose (Day 1)
Population: PK analysis set included subjects who received active treatment (MSB0010841) without protocol deviations affecting PK, and who provide evaluable PK data. Here Number of participants analyzed signifies those subjects who were evaluable for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| MSB0010841 30 mg | Maximum Concentration Observed (Cmax) Post First Dose of MSB0010841 | 3.3 mcg/mL | Geometric Coefficient of Variation 28.4 |
| MSB0010841 60 mg | Maximum Concentration Observed (Cmax) Post First Dose of MSB0010841 | 7.4 mcg/mL | Geometric Coefficient of Variation 22.9 |
| MSB0010841 120 mg | Maximum Concentration Observed (Cmax) Post First Dose of MSB0010841 | 12.5 mcg/mL | Geometric Coefficient of Variation 25.6 |
| MSB0010841 240 mg | Maximum Concentration Observed (Cmax) Post First Dose of MSB0010841 | 20.8 mcg/mL | Geometric Coefficient of Variation 30.3 |
Maximum Concentration Observed (Cmax) Post Third Dose of MSB0010841
Time frame: 0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336, 504, 816, 1056, 1344 hours post-third dose (Day 29)
Population: PK analysis set included subjects who received active treatment (MSB0010841) without protocol deviations affecting PK, and who provide evaluable PK data. Here Number of participants analyzed signifies those subjects who were evaluable for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| MSB0010841 30 mg | Maximum Concentration Observed (Cmax) Post Third Dose of MSB0010841 | 5.14 mcg/mL | Geometric Coefficient of Variation 34.5 |
| MSB0010841 60 mg | Maximum Concentration Observed (Cmax) Post Third Dose of MSB0010841 | 11.32 mcg/mL | Geometric Coefficient of Variation 29.7 |
| MSB0010841 120 mg | Maximum Concentration Observed (Cmax) Post Third Dose of MSB0010841 | 19.74 mcg/mL | Geometric Coefficient of Variation 31.3 |
| MSB0010841 240 mg | Maximum Concentration Observed (Cmax) Post Third Dose of MSB0010841 | 37.93 mcg/mL | Geometric Coefficient of Variation 32.2 |
Maximum Observed Concentration (Cmax) Post Second Dose of MSB0010841
Time frame: 0 hours (pre-dose), 24, 72, 96, 168, 336 hours post-second dose (Day 15)
Population: PK analysis set included subjects who received active treatment (MSB0010841) without protocol deviations affecting PK, and who provide evaluable PK data. Here Number of subjects analyzed signifies those subjects who were evaluable for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| MSB0010841 30 mg | Maximum Observed Concentration (Cmax) Post Second Dose of MSB0010841 | 4.26 mcg/mL | Geometric Coefficient of Variation 32.7 |
| MSB0010841 60 mg | Maximum Observed Concentration (Cmax) Post Second Dose of MSB0010841 | 9.06 mcg/mL | Geometric Coefficient of Variation 24.2 |
| MSB0010841 120 mg | Maximum Observed Concentration (Cmax) Post Second Dose of MSB0010841 | 18.59 mcg/mL | Geometric Coefficient of Variation 23.1 |
| MSB0010841 240 mg | Maximum Observed Concentration (Cmax) Post Second Dose of MSB0010841 | 30.98 mcg/mL | Geometric Coefficient of Variation 25.3 |
Mean Residence Time (MRT0-t) Post First Dose of MSB0010841
MRT is the average time at which the number of absorbed molecules reside in the body, after single-dose administration, and calculated as AUMC(0-t)/AUC(0-t) where AUMC(0-t) is area under the plasma concentration-time first moment curve from time zero to time t (336 hours) and AUC(0-t) is the area under the plasma concentration-time curve from time zero to tome t (336 hours).
Time frame: 0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336 hours post-first dose (Day 1)
Population: PK analysis set included subjects who received active treatment (MSB0010841) without protocol deviations affecting PK, and who provide evaluable PK data. Here Number of participants analyzed signifies those subjects who were evaluable for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| MSB0010841 30 mg | Mean Residence Time (MRT0-t) Post First Dose of MSB0010841 | 6.528 day | Geometric Coefficient of Variation 3.6 |
| MSB0010841 60 mg | Mean Residence Time (MRT0-t) Post First Dose of MSB0010841 | 6.691 day | Geometric Coefficient of Variation 8.1 |
| MSB0010841 120 mg | Mean Residence Time (MRT0-t) Post First Dose of MSB0010841 | 6.638 day | Geometric Coefficient of Variation 5.7 |
| MSB0010841 240 mg | Mean Residence Time (MRT0-t) Post First Dose of MSB0010841 | 6.771 day | Geometric Coefficient of Variation 5.3 |
Mean Residence Time (MRT0-t) Post Third Dose of MSB0010841
MRT is the average time at which the number of absorbed molecules reside in the body, after single-dose administration, and calculated as AUMC(0-t)/AUC(0-t) where AUMC(0-t) is area under the plasma concentration-time first moment curve from time zero to time t (336 hours) and AUC(0-t) is the area under the plasma concentration-time curve from time zero to tome t (336 hours).
Time frame: 0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336 hours post-third dose (Day 29)
Population: PK analysis set included subjects who received active treatment (MSB0010841) without protocol deviations affecting PK, and who provide evaluable PK data. Here Number of participants analyzed signifies those subjects who were evaluable for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| MSB0010841 30 mg | Mean Residence Time (MRT0-t) Post Third Dose of MSB0010841 | 17.57 day | Geometric Coefficient of Variation 11.2 |
| MSB0010841 60 mg | Mean Residence Time (MRT0-t) Post Third Dose of MSB0010841 | 15.68 day | Geometric Coefficient of Variation 16.3 |
| MSB0010841 120 mg | Mean Residence Time (MRT0-t) Post Third Dose of MSB0010841 | 19.26 day | Geometric Coefficient of Variation 32 |
| MSB0010841 240 mg | Mean Residence Time (MRT0-t) Post Third Dose of MSB0010841 | 16.38 day | Geometric Coefficient of Variation 11.3 |
Mean Residence Time of Drug in the Body From Time Zero Extrapolated to Infinity (MRT(0-inf) Post Third Dose of MSB0010841
Mean residence time of drug in the body from time zero extrapolated to infinity, based on the last predicted concentration at tlast.
Time frame: 0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336, 504, 816, 1056, 1344 hours post-third dose (Day 29)
Population: PK analysis set included subjects who received active treatment (MSB0010841) without protocol deviations affecting PK, and who provide evaluable PK data. Here Number of participants analyzed signifies those subjects who were evaluable for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| MSB0010841 30 mg | Mean Residence Time of Drug in the Body From Time Zero Extrapolated to Infinity (MRT(0-inf) Post Third Dose of MSB0010841 | 17.57 day | Geometric Coefficient of Variation 11.2 |
| MSB0010841 60 mg | Mean Residence Time of Drug in the Body From Time Zero Extrapolated to Infinity (MRT(0-inf) Post Third Dose of MSB0010841 | 15.68 day | Geometric Coefficient of Variation 16.3 |
| MSB0010841 120 mg | Mean Residence Time of Drug in the Body From Time Zero Extrapolated to Infinity (MRT(0-inf) Post Third Dose of MSB0010841 | 19.26 day | Geometric Coefficient of Variation 32 |
| MSB0010841 240 mg | Mean Residence Time of Drug in the Body From Time Zero Extrapolated to Infinity (MRT(0-inf) Post Third Dose of MSB0010841 | 16.38 day | Geometric Coefficient of Variation 11.3 |
Minimum Concentration Observed (Cmin) During First Dosing Interval of MSB0010841
The observed minimum serum concentration determined directly from the serum concentration-time profile of each subject.
Time frame: 0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336 hours post-first dose (Day 1)
Population: PK analysis set included subjects who received active treatment (MSB0010841) without protocol deviations affecting PK, and who provide evaluable PK data. Here Number of participants analyzed signifies those subjects who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MSB0010841 30 mg | Minimum Concentration Observed (Cmin) During First Dosing Interval of MSB0010841 | 0.01 mcg/mL | Standard Deviation 0.036 |
| MSB0010841 60 mg | Minimum Concentration Observed (Cmin) During First Dosing Interval of MSB0010841 | 0.00 mcg/mL | Standard Deviation 0 |
| MSB0010841 120 mg | Minimum Concentration Observed (Cmin) During First Dosing Interval of MSB0010841 | 0.00 mcg/mL | Standard Deviation 0 |
| MSB0010841 240 mg | Minimum Concentration Observed (Cmin) During First Dosing Interval of MSB0010841 | 0.00 mcg/mL | Standard Deviation 0 |
Minimum Concentration Observed (Cmin) During Third Dosing Interval of MSB0010841
The observed minimum serum concentration determined directly from the serum concentration-time profile of each subject.
Time frame: 0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336, 504, 816, 1056, 1344 hours post-third dose (Day 29)
Population: PK analysis set included subjects who received active treatment (MSB0010841) without protocol deviations affecting PK, and who provide evaluable PK data. Here Number of participants analyzed signifies those subjects who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MSB0010841 30 mg | Minimum Concentration Observed (Cmin) During Third Dosing Interval of MSB0010841 | 2.30 mcg/mL | Standard Deviation 0.6 |
| MSB0010841 60 mg | Minimum Concentration Observed (Cmin) During Third Dosing Interval of MSB0010841 | 4.34 mcg/mL | Standard Deviation 1.4 |
| MSB0010841 120 mg | Minimum Concentration Observed (Cmin) During Third Dosing Interval of MSB0010841 | 10.03 mcg/mL | Standard Deviation 4.95 |
| MSB0010841 240 mg | Minimum Concentration Observed (Cmin) During Third Dosing Interval of MSB0010841 | 16.17 mcg/mL | Standard Deviation 4.84 |
MSB0010841 Serum Concentration Over Time After First Dose
Time frame: 0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336 hours post-first dose (Day 1)
Population: PK analysis set included subjects who received first dose of MSB0010841 without protocol deviations affecting PK, and who provide evaluable PK data. Here n signifies those subjects who were evaluable for this outcome measure at the specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MSB0010841 30 mg | MSB0010841 Serum Concentration Over Time After First Dose | 96 hour (n=8,8,8,8) | 3155.8 nanogram/milliliter (ng/mL) | Standard Deviation 879.56 |
| MSB0010841 30 mg | MSB0010841 Serum Concentration Over Time After First Dose | 72 hour (n=8,8,7,8) | 3190.4 nanogram/milliliter (ng/mL) | Standard Deviation 810.18 |
| MSB0010841 30 mg | MSB0010841 Serum Concentration Over Time After First Dose | 336 hour (n=8,8,8,8) | 1704.3 nanogram/milliliter (ng/mL) | Standard Deviation 429.78 |
| MSB0010841 30 mg | MSB0010841 Serum Concentration Over Time After First Dose | 24 hour (n=8,8,8,9) | 2788.4 nanogram/milliliter (ng/mL) | Standard Deviation 895.89 |
| MSB0010841 30 mg | MSB0010841 Serum Concentration Over Time After First Dose | 12 hour (n=8,8,8,9) | 1793.3 nanogram/milliliter (ng/mL) | Standard Deviation 761.23 |
| MSB0010841 30 mg | MSB0010841 Serum Concentration Over Time After First Dose | 6 hour (n=8,8,8,9) | 907.5 nanogram/milliliter (ng/mL) | Standard Deviation 523.16 |
| MSB0010841 30 mg | MSB0010841 Serum Concentration Over Time After First Dose | 168 hour (n=8,8,8,8) | 2665.5 nanogram/milliliter (ng/mL) | Standard Deviation 605.89 |
| MSB0010841 30 mg | MSB0010841 Serum Concentration Over Time After First Dose | 32 hour (n=8,8,8,9) | 3037.3 nanogram/milliliter (ng/mL) | Standard Deviation 820.76 |
| MSB0010841 30 mg | MSB0010841 Serum Concentration Over Time After First Dose | 0 hour (n=8,8,8,9) | 12.6 nanogram/milliliter (ng/mL) | Standard Deviation 35.71 |
| MSB0010841 60 mg | MSB0010841 Serum Concentration Over Time After First Dose | 32 hour (n=8,8,8,9) | 6028.1 nanogram/milliliter (ng/mL) | Standard Deviation 2269.66 |
| MSB0010841 60 mg | MSB0010841 Serum Concentration Over Time After First Dose | 96 hour (n=8,8,8,8) | 6423.8 nanogram/milliliter (ng/mL) | Standard Deviation 1824.46 |
| MSB0010841 60 mg | MSB0010841 Serum Concentration Over Time After First Dose | 72 hour (n=8,8,7,8) | 6492.9 nanogram/milliliter (ng/mL) | Standard Deviation 1472.29 |
| MSB0010841 60 mg | MSB0010841 Serum Concentration Over Time After First Dose | 6 hour (n=8,8,8,9) | 2097.1 nanogram/milliliter (ng/mL) | Standard Deviation 1391.43 |
| MSB0010841 60 mg | MSB0010841 Serum Concentration Over Time After First Dose | 0 hour (n=8,8,8,9) | 0.0 nanogram/milliliter (ng/mL) | Standard Deviation 0 |
| MSB0010841 60 mg | MSB0010841 Serum Concentration Over Time After First Dose | 12 hour (n=8,8,8,9) | 3339.6 nanogram/milliliter (ng/mL) | Standard Deviation 1671.29 |
| MSB0010841 60 mg | MSB0010841 Serum Concentration Over Time After First Dose | 336 hour (n=8,8,8,8) | 3951.0 nanogram/milliliter (ng/mL) | Standard Deviation 1353.92 |
| MSB0010841 60 mg | MSB0010841 Serum Concentration Over Time After First Dose | 168 hour (n=8,8,8,8) | 5179.5 nanogram/milliliter (ng/mL) | Standard Deviation 1126.74 |
| MSB0010841 60 mg | MSB0010841 Serum Concentration Over Time After First Dose | 24 hour (n=8,8,8,9) | 5047.8 nanogram/milliliter (ng/mL) | Standard Deviation 1600.25 |
| MSB0010841 120 mg | MSB0010841 Serum Concentration Over Time After First Dose | 32 hour (n=8,8,8,9) | 11372.4 nanogram/milliliter (ng/mL) | Standard Deviation 3499.37 |
| MSB0010841 120 mg | MSB0010841 Serum Concentration Over Time After First Dose | 0 hour (n=8,8,8,9) | 0.0 nanogram/milliliter (ng/mL) | Standard Deviation 0 |
| MSB0010841 120 mg | MSB0010841 Serum Concentration Over Time After First Dose | 6 hour (n=8,8,8,9) | 2315.5 nanogram/milliliter (ng/mL) | Standard Deviation 787.02 |
| MSB0010841 120 mg | MSB0010841 Serum Concentration Over Time After First Dose | 12 hour (n=8,8,8,9) | 4983.1 nanogram/milliliter (ng/mL) | Standard Deviation 1501.41 |
| MSB0010841 120 mg | MSB0010841 Serum Concentration Over Time After First Dose | 24 hour (n=8,8,8,9) | 9131.3 nanogram/milliliter (ng/mL) | Standard Deviation 2838.02 |
| MSB0010841 120 mg | MSB0010841 Serum Concentration Over Time After First Dose | 72 hour (n=8,8,7,8) | 11284.1 nanogram/milliliter (ng/mL) | Standard Deviation 2562.84 |
| MSB0010841 120 mg | MSB0010841 Serum Concentration Over Time After First Dose | 96 hour (n=8,8,8,8) | 11790.0 nanogram/milliliter (ng/mL) | Standard Deviation 3319.36 |
| MSB0010841 120 mg | MSB0010841 Serum Concentration Over Time After First Dose | 168 hour (n=8,8,8,8) | 10318.6 nanogram/milliliter (ng/mL) | Standard Deviation 2837.81 |
| MSB0010841 120 mg | MSB0010841 Serum Concentration Over Time After First Dose | 336 hour (n=8,8,8,8) | 6768.4 nanogram/milliliter (ng/mL) | Standard Deviation 2846.24 |
| MSB0010841 240 mg | MSB0010841 Serum Concentration Over Time After First Dose | 96 hour (n=8,8,8,8) | 18732.9 nanogram/milliliter (ng/mL) | Standard Deviation 4670.66 |
| MSB0010841 240 mg | MSB0010841 Serum Concentration Over Time After First Dose | 24 hour (n=8,8,8,9) | 15357.6 nanogram/milliliter (ng/mL) | Standard Deviation 5295.18 |
| MSB0010841 240 mg | MSB0010841 Serum Concentration Over Time After First Dose | 12 hour (n=8,8,8,9) | 9780.3 nanogram/milliliter (ng/mL) | Standard Deviation 4698.97 |
| MSB0010841 240 mg | MSB0010841 Serum Concentration Over Time After First Dose | 336 hour (n=8,8,8,8) | 11605.8 nanogram/milliliter (ng/mL) | Standard Deviation 2065.58 |
| MSB0010841 240 mg | MSB0010841 Serum Concentration Over Time After First Dose | 168 hour (n=8,8,8,8) | 17761.9 nanogram/milliliter (ng/mL) | Standard Deviation 3072.48 |
| MSB0010841 240 mg | MSB0010841 Serum Concentration Over Time After First Dose | 6 hour (n=8,8,8,9) | 4858.8 nanogram/milliliter (ng/mL) | Standard Deviation 2326.35 |
| MSB0010841 240 mg | MSB0010841 Serum Concentration Over Time After First Dose | 72 hour (n=8,8,7,8) | 20536.6 nanogram/milliliter (ng/mL) | Standard Deviation 6716.38 |
| MSB0010841 240 mg | MSB0010841 Serum Concentration Over Time After First Dose | 32 hour (n=8,8,8,9) | 17135.2 nanogram/milliliter (ng/mL) | Standard Deviation 6032.66 |
| MSB0010841 240 mg | MSB0010841 Serum Concentration Over Time After First Dose | 0 hour (n=8,8,8,9) | 0.0 nanogram/milliliter (ng/mL) | Standard Deviation 0 |
MSB0010841 Serum Concentration Over Time After Second Dose
Time frame: 0 hours (pre-dose), 24, 72, 96, 168, 336 hours post-second dose (Day 15)
Population: PK analysis set included subjects who received active treatment (MSB0010841) without protocol deviations affecting PK, and who provide evaluable PK data. Here Number of participants analyzed signifies those subjects who were evaluable for this outcome measure at the specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MSB0010841 30 mg | MSB0010841 Serum Concentration Over Time After Second Dose | 96 hour | 4020.5 ng/mL | Standard Deviation 923.65 |
| MSB0010841 30 mg | MSB0010841 Serum Concentration Over Time After Second Dose | 0 hour | 1704.3 ng/mL | Standard Deviation 429.78 |
| MSB0010841 30 mg | MSB0010841 Serum Concentration Over Time After Second Dose | 72 hour | 4309.0 ng/mL | Standard Deviation 1265.45 |
| MSB0010841 30 mg | MSB0010841 Serum Concentration Over Time After Second Dose | 168 hour | 3517.8 ng/mL | Standard Deviation 877.96 |
| MSB0010841 30 mg | MSB0010841 Serum Concentration Over Time After Second Dose | 336 hour | 2306.5 ng/mL | Standard Deviation 588.5 |
| MSB0010841 30 mg | MSB0010841 Serum Concentration Over Time After Second Dose | 24 hour | 3808.0 ng/mL | Standard Deviation 980.68 |
| MSB0010841 60 mg | MSB0010841 Serum Concentration Over Time After Second Dose | 336 hour | 4492.9 ng/mL | Standard Deviation 1398.63 |
| MSB0010841 60 mg | MSB0010841 Serum Concentration Over Time After Second Dose | 168 hour | 7180.4 ng/mL | Standard Deviation 1705.24 |
| MSB0010841 60 mg | MSB0010841 Serum Concentration Over Time After Second Dose | 0 hour | 3951.0 ng/mL | Standard Deviation 1353.92 |
| MSB0010841 60 mg | MSB0010841 Serum Concentration Over Time After Second Dose | 96 hour | 8514.4 ng/mL | Standard Deviation 1849.44 |
| MSB0010841 60 mg | MSB0010841 Serum Concentration Over Time After Second Dose | 72 hour | 9095.5 ng/mL | Standard Deviation 2115.16 |
| MSB0010841 60 mg | MSB0010841 Serum Concentration Over Time After Second Dose | 24 hour | 7268.9 ng/mL | Standard Deviation 3771.98 |
| MSB0010841 120 mg | MSB0010841 Serum Concentration Over Time After Second Dose | 168 hour | 14806.6 ng/mL | Standard Deviation 5632.99 |
| MSB0010841 120 mg | MSB0010841 Serum Concentration Over Time After Second Dose | 96 hour | 17081.4 ng/mL | Standard Deviation 5056.17 |
| MSB0010841 120 mg | MSB0010841 Serum Concentration Over Time After Second Dose | 336 hour | 10468.9 ng/mL | Standard Deviation 4376.75 |
| MSB0010841 120 mg | MSB0010841 Serum Concentration Over Time After Second Dose | 0 hour | 6768.4 ng/mL | Standard Deviation 2846.24 |
| MSB0010841 120 mg | MSB0010841 Serum Concentration Over Time After Second Dose | 24 hour | 15120.6 ng/mL | Standard Deviation 3393.84 |
| MSB0010841 120 mg | MSB0010841 Serum Concentration Over Time After Second Dose | 72 hour | 17454.4 ng/mL | Standard Deviation 4152.32 |
| MSB0010841 240 mg | MSB0010841 Serum Concentration Over Time After Second Dose | 168 hour | 22972.5 ng/mL | Standard Deviation 11219.87 |
| MSB0010841 240 mg | MSB0010841 Serum Concentration Over Time After Second Dose | 72 hour | 29902.4 ng/mL | Standard Deviation 7523.13 |
| MSB0010841 240 mg | MSB0010841 Serum Concentration Over Time After Second Dose | 24 hour | 27664.8 ng/mL | Standard Deviation 9231.41 |
| MSB0010841 240 mg | MSB0010841 Serum Concentration Over Time After Second Dose | 96 hour | 29223.5 ng/mL | Standard Deviation 8336.26 |
| MSB0010841 240 mg | MSB0010841 Serum Concentration Over Time After Second Dose | 0 hour | 11605.8 ng/mL | Standard Deviation 2065.58 |
| MSB0010841 240 mg | MSB0010841 Serum Concentration Over Time After Second Dose | 336 hour | 16454.5 ng/mL | Standard Deviation 4548.85 |
MSB0010841 Serum Concentration Over Time After Third Dose
Time frame: 0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336, 504, 816, 1056, 1344 hours post-third dose (Day 29)
Population: PK analysis set included subjects who received active treatment (MSB0010841) without protocol deviations affecting PK, and who provide evaluable PK data. Here Number of participants analyzed signifies those subjects who were evaluable for this outcome measure at the specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MSB0010841 30 mg | MSB0010841 Serum Concentration Over Time After Third Dose | 6 hour | 3483.9 ng/mL | Standard Deviation 1566.88 |
| MSB0010841 30 mg | MSB0010841 Serum Concentration Over Time After Third Dose | 32 hour | 4934.5 ng/mL | Standard Deviation 1256.47 |
| MSB0010841 30 mg | MSB0010841 Serum Concentration Over Time After Third Dose | 24 hour | 4533.3 ng/mL | Standard Deviation 1178.14 |
| MSB0010841 30 mg | MSB0010841 Serum Concentration Over Time After Third Dose | 816 hour | 933.1 ng/mL | Standard Deviation 376.76 |
| MSB0010841 30 mg | MSB0010841 Serum Concentration Over Time After Third Dose | 1344 hour | 244.8 ng/mL | Standard Deviation 162.24 |
| MSB0010841 30 mg | MSB0010841 Serum Concentration Over Time After Third Dose | 12 hour | 3557.9 ng/mL | Standard Deviation 1004.43 |
| MSB0010841 30 mg | MSB0010841 Serum Concentration Over Time After Third Dose | 168 hour | 4368.1 ng/mL | Standard Deviation 1201.56 |
| MSB0010841 30 mg | MSB0010841 Serum Concentration Over Time After Third Dose | 0 hour | 2306.5 ng/mL | Standard Deviation 588.5 |
| MSB0010841 30 mg | MSB0010841 Serum Concentration Over Time After Third Dose | 336 hour | 2680.5 ng/mL | Standard Deviation 859.35 |
| MSB0010841 30 mg | MSB0010841 Serum Concentration Over Time After Third Dose | 1056 hour | 464.5 ng/mL | Standard Deviation 257.13 |
| MSB0010841 30 mg | MSB0010841 Serum Concentration Over Time After Third Dose | 96 hour | 4994.9 ng/mL | Standard Deviation 1448.53 |
| MSB0010841 30 mg | MSB0010841 Serum Concentration Over Time After Third Dose | 72 hour | 4936.0 ng/mL | Standard Deviation 1387.5 |
| MSB0010841 30 mg | MSB0010841 Serum Concentration Over Time After Third Dose | 504 hour | 1802.0 ng/mL | Standard Deviation 505.42 |
| MSB0010841 60 mg | MSB0010841 Serum Concentration Over Time After Third Dose | 96 hour | 9047.6 ng/mL | Standard Deviation 2760.25 |
| MSB0010841 60 mg | MSB0010841 Serum Concentration Over Time After Third Dose | 0 hour | 4492.9 ng/mL | Standard Deviation 1398.63 |
| MSB0010841 60 mg | MSB0010841 Serum Concentration Over Time After Third Dose | 6 hour | 6200.1 ng/mL | Standard Deviation 1391.38 |
| MSB0010841 60 mg | MSB0010841 Serum Concentration Over Time After Third Dose | 336 hour | 5602.1 ng/mL | Standard Deviation 3057.34 |
| MSB0010841 60 mg | MSB0010841 Serum Concentration Over Time After Third Dose | 504 hour | 3109.1 ng/mL | Standard Deviation 1519.66 |
| MSB0010841 60 mg | MSB0010841 Serum Concentration Over Time After Third Dose | 816 hour | 1378.1 ng/mL | Standard Deviation 834.66 |
| MSB0010841 60 mg | MSB0010841 Serum Concentration Over Time After Third Dose | 72 hour | 10345.6 ng/mL | Standard Deviation 4586.24 |
| MSB0010841 60 mg | MSB0010841 Serum Concentration Over Time After Third Dose | 12 hour | 8615.5 ng/mL | Standard Deviation 3093.46 |
| MSB0010841 60 mg | MSB0010841 Serum Concentration Over Time After Third Dose | 24 hour | 9969.9 ng/mL | Standard Deviation 2494.6 |
| MSB0010841 60 mg | MSB0010841 Serum Concentration Over Time After Third Dose | 32 hour | 10762.5 ng/mL | Standard Deviation 2377.88 |
| MSB0010841 60 mg | MSB0010841 Serum Concentration Over Time After Third Dose | 168 hour | 7715.4 ng/mL | Standard Deviation 3019.93 |
| MSB0010841 60 mg | MSB0010841 Serum Concentration Over Time After Third Dose | 1056 hour | 658.5 ng/mL | Standard Deviation 391.39 |
| MSB0010841 60 mg | MSB0010841 Serum Concentration Over Time After Third Dose | 1344 hour | 326.3 ng/mL | Standard Deviation 230.87 |
| MSB0010841 120 mg | MSB0010841 Serum Concentration Over Time After Third Dose | 12 hour | 13361.0 ng/mL | Standard Deviation 5959.26 |
| MSB0010841 120 mg | MSB0010841 Serum Concentration Over Time After Third Dose | 24 hour | 17523.1 ng/mL | Standard Deviation 6140.31 |
| MSB0010841 120 mg | MSB0010841 Serum Concentration Over Time After Third Dose | 504 hour | 8610.6 ng/mL | Standard Deviation 5991.68 |
| MSB0010841 120 mg | MSB0010841 Serum Concentration Over Time After Third Dose | 0 hour | 10417.7 ng/mL | Standard Deviation 4724.84 |
| MSB0010841 120 mg | MSB0010841 Serum Concentration Over Time After Third Dose | 32 hour | 18634.9 ng/mL | Standard Deviation 5713.14 |
| MSB0010841 120 mg | MSB0010841 Serum Concentration Over Time After Third Dose | 72 hour | 19813.1 ng/mL | Standard Deviation 6381.27 |
| MSB0010841 120 mg | MSB0010841 Serum Concentration Over Time After Third Dose | 336 hour | 12257.6 ng/mL | Standard Deviation 7468.85 |
| MSB0010841 120 mg | MSB0010841 Serum Concentration Over Time After Third Dose | 168 hour | 15585.3 ng/mL | Standard Deviation 5625.65 |
| MSB0010841 120 mg | MSB0010841 Serum Concentration Over Time After Third Dose | 96 hour | 18260.1 ng/mL | Standard Deviation 6602.9 |
| MSB0010841 120 mg | MSB0010841 Serum Concentration Over Time After Third Dose | 1344 hour | 1611.3 ng/mL | Standard Deviation 2199.92 |
| MSB0010841 120 mg | MSB0010841 Serum Concentration Over Time After Third Dose | 6 hour | 12725.0 ng/mL | Standard Deviation 5573.11 |
| MSB0010841 120 mg | MSB0010841 Serum Concentration Over Time After Third Dose | 816 hour | 4309.3 ng/mL | Standard Deviation 4044.88 |
| MSB0010841 120 mg | MSB0010841 Serum Concentration Over Time After Third Dose | 1056 hour | 2599.7 ng/mL | Standard Deviation 2937.08 |
| MSB0010841 240 mg | MSB0010841 Serum Concentration Over Time After Third Dose | 6 hour | 20452.3 ng/mL | Standard Deviation 6683.19 |
| MSB0010841 240 mg | MSB0010841 Serum Concentration Over Time After Third Dose | 504 hour | 12472.4 ng/mL | Standard Deviation 4176 |
| MSB0010841 240 mg | MSB0010841 Serum Concentration Over Time After Third Dose | 1056 hour | 2475.9 ng/mL | Standard Deviation 1391.08 |
| MSB0010841 240 mg | MSB0010841 Serum Concentration Over Time After Third Dose | 12 hour | 26051.4 ng/mL | Standard Deviation 8770.65 |
| MSB0010841 240 mg | MSB0010841 Serum Concentration Over Time After Third Dose | 24 hour | 33651.7 ng/mL | Standard Deviation 11590.56 |
| MSB0010841 240 mg | MSB0010841 Serum Concentration Over Time After Third Dose | 96 hour | 33909.3 ng/mL | Standard Deviation 10219.54 |
| MSB0010841 240 mg | MSB0010841 Serum Concentration Over Time After Third Dose | 168 hour | 31375.9 ng/mL | Standard Deviation 6826.5 |
| MSB0010841 240 mg | MSB0010841 Serum Concentration Over Time After Third Dose | 1344 hour | 1345.7 ng/mL | Standard Deviation 879.15 |
| MSB0010841 240 mg | MSB0010841 Serum Concentration Over Time After Third Dose | 32 hour | 38278.4 ng/mL | Standard Deviation 13391.4 |
| MSB0010841 240 mg | MSB0010841 Serum Concentration Over Time After Third Dose | 336 hour | 20011.9 ng/mL | Standard Deviation 6248.98 |
| MSB0010841 240 mg | MSB0010841 Serum Concentration Over Time After Third Dose | 0 hour | 16173.6 ng/mL | Standard Deviation 4837.78 |
| MSB0010841 240 mg | MSB0010841 Serum Concentration Over Time After Third Dose | 72 hour | 37166.4 ng/mL | Standard Deviation 10103.58 |
| MSB0010841 240 mg | MSB0010841 Serum Concentration Over Time After Third Dose | 816 hour | 5064.6 ng/mL | Standard Deviation 2070.93 |
Number of Subjects With Local Injection Site Reactions (ISRs)
The injection site was assessed by the Principal Investigator (PI) or his/her designee for local reactions such as redness, swelling, indurations or bruising, and by the subject for itching. Redness and bruising were scaled as None (no visible redness or bruising present); Mild (less than or equal to \[\<=\] 2.0 centimeters \[cm\] redness or bruising area); Moderate (greater than \[\>\] 2 to \<=5.0 cm redness or bruising area); Severe (\>5.0 cm redness or bruising area). Swelling was scaled as None (no swelling detected); Mild (palpable 'firmness' only); Moderate (\<= 4 cm swelling); Severe (\>4 cm swelling). Induration was scaled as None (no induration); Mild (able to move skin parallel to plane (sliding) and perpendicular to skin (pinching up); Moderate (able to slide skin, unable to pinch skin); Severe (unable to slide or pinch skin). Itching was scaled as No itching; Mild itching; Moderate itching and Severe itching. Subjects who reported any of the local ISRs were reported.
Time frame: Day 1, 2,8, 15, 16, 22, 29, 30, 36, 43
Population: Safety analysis set included all 41 subjects who received at least one dose of IMP (MSB0010841 or placebo). Here n signifies those subjects who were evaluable for the specified injection site reaction. Subjects may be represented in more than 1 category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MSB0010841 30 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 22 Indurations: none (n=8,8,8,8,8) | 8 subjects |
| MSB0010841 30 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 1 Redness: mild (n=8,8,8,9,8) | 0 subjects |
| MSB0010841 30 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 1 Redness: none (n=8,8,8,9,8) | 8 subjects |
| MSB0010841 30 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 1 Itching: mild (n=8,8,8,9,8) | 0 subjects |
| MSB0010841 30 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 30 Redness: none (n==8,8,7,7,8) | 8 subjects |
| MSB0010841 30 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 22 Bruising: mild (n=8,8,8,8,8) | 0 subjects |
| MSB0010841 30 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 15 Swelling: none (n=8,8,8,8,8) | 8 subjects |
| MSB0010841 30 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 15 Redness: moderate (n=8,8,8,8,8) | 0 subjects |
| MSB0010841 30 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 43 Indurations: none (n=8,8,8,8,8) | 8 subjects |
| MSB0010841 30 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 30 Redness: moderate (n=8,8,7,7,8) | 0 subjects |
| MSB0010841 30 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 15 Indurations: none (n=8,8,8,8,8) | 8 subjects |
| MSB0010841 30 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 43 Bruising: none (n=8,8,8,8,8) | 8 subjects |
| MSB0010841 30 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 36 Itching: none (n=7,8,7,6,8) | 7 subjects |
| MSB0010841 30 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 36 Indurations: none (n=8,8,7,7,7) | 8 subjects |
| MSB0010841 30 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 30 Swelling: none (n=8,8,7,7,8) | 8 subjects |
| MSB0010841 30 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 29 Itching: none (n=8,8,8,7,8) | 8 subjects |
| MSB0010841 30 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 36 Bruising: mild (n=7,8,7,7,8) | 0 subjects |
| MSB0010841 30 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 36 Bruising: none (n=7,8,7,7,8) | 7 subjects |
| MSB0010841 30 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 22 Redness: severe (n=8,8,8,8,8) | 0 subjects |
| MSB0010841 30 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 22 Bruising: none (n=8,8,8,8,8) | 8 subjects |
| MSB0010841 30 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 29 Bruising: none (n=8,8,8,7,8) | 8 subjects |
| MSB0010841 30 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 16 Swelling: mild (n=8,8,8,8,8) | 0 subjects |
| MSB0010841 30 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 16 Swelling: none (n=8,8,8,8,8) | 8 subjects |
| MSB0010841 30 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 1 Itching: none (n=8,8,8,9,8) | 8 subjects |
| MSB0010841 30 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 15 Redness: mild (n=8,8,8,8,8) | 0 subjects |
| MSB0010841 30 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 1 Indurations: none (n=8,8,8,9,8) | 8 subjects |
| MSB0010841 30 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 1 Indurations: mild (n=8,8,8,9,8) | 0 subjects |
| MSB0010841 30 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 22 Redness: none (n=8,8,8,8,8) | 8 subjects |
| MSB0010841 30 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 29 Redness: none (n=8,8,8,8,8) | 8 subjects |
| MSB0010841 30 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 22 Itching: mild (n=8,8,8,8,8) | 1 subjects |
| MSB0010841 30 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 1 Bruising: none (n=8,8,8,9,8) | 8 subjects |
| MSB0010841 30 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 43 Swelling: none (n=8,8,8,8,8) | 8 subjects |
| MSB0010841 30 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 43 Redness: moderate (n=8,8,8,8,8) | 0 subjects |
| MSB0010841 30 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 43 Redness: none (n=8,8,8,8,8) | 8 subjects |
| MSB0010841 30 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 29 Redness: mild (n=8,8,8,8,8) | 0 subjects |
| MSB0010841 30 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 22 Swelling: severe (n=8,8,8,8,8) | 0 subjects |
| MSB0010841 30 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 16 Redness: mild (n=8,8,8,8,8) | 1 subjects |
| MSB0010841 30 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 16 Redness: none (n=8,8,8,8,8) | 7 subjects |
| MSB0010841 30 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 16 Itching: none (n=8,8,8,8,8) | 8 subjects |
| MSB0010841 30 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 29 Redness: moderate (n=8,8,8,8,8) | 0 subjects |
| MSB0010841 30 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 22 Itching: none (n=8,8,8,8,8) | 7 subjects |
| MSB0010841 30 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 16 Indurations: none (n=8,8,8,8,8) | 8 subjects |
| MSB0010841 30 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 16 Bruising: mild (n=8,8,8,8,8) | 0 subjects |
| MSB0010841 30 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 43 Itching: none (8,8,8,8,8) | 8 subjects |
| MSB0010841 30 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 16 Bruising: none (n=8,8,8,8,8) | 8 subjects |
| MSB0010841 30 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 29 Swelling: none (n=8,8,8,7,8) | 8 subjects |
| MSB0010841 30 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 15 Itching: none (n=8,8,8,8,8) | 8 subjects |
| MSB0010841 30 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 15 Bruising: none (n=8,8,8,8,8) | 8 subjects |
| MSB0010841 30 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 8 Swelling: none (n=8,8,8,8,8) | 8 subjects |
| MSB0010841 30 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 8 Redness: mild (n=8,8,8,8,8) | 1 subjects |
| MSB0010841 30 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 29 Swelling: mild (n=8,8,8,7,8) | 0 subjects |
| MSB0010841 30 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 22 Indurations: severe (n=8,8,8,8,8) | 0 subjects |
| MSB0010841 30 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 8 Redness: none (n=8,8,8,8,8) | 7 subjects |
| MSB0010841 30 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 8 Itching: none (n=8,8,8,8,8) | 8 subjects |
| MSB0010841 30 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 8 Indurations: none (n=8,8,8,8,8) | 8 subjects |
| MSB0010841 30 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 30 Bruising: none (n=8,8,8,7,8) | 8 subjects |
| MSB0010841 30 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 29 Indurations: none (n=8,8,7,7,8) | 8 subjects |
| MSB0010841 30 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 8 Bruising: none (n=8,8,8,8,8) | 8 subjects |
| MSB0010841 30 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 2 Swelling: none (n=8,8,8,9,8) | 8 subjects |
| MSB0010841 30 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 2 Redness: none (n=8,8,8,9,8) | 8 subjects |
| MSB0010841 30 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 30 Bruising: mild (n=8,8,8,7,8) | 0 subjects |
| MSB0010841 30 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 15 Redness: none (n=8,8,8,8,8) | 8 subjects |
| MSB0010841 30 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 2 Itching: none (n=8,8,8,9,8) | 8 subjects |
| MSB0010841 30 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 2 Indurations: none (n=8,8,8,9,8) | 8 subjects |
| MSB0010841 30 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 2 Bruising: mild (n=8,8,8,9,8) | 3 subjects |
| MSB0010841 30 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 30 Indurations: none (n=8,8,7,7,8) | 8 subjects |
| MSB0010841 30 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 22 Swelling: none (n=8,8,8,8,8) | 8 subjects |
| MSB0010841 30 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 2 Bruising: none (n=8,8,8,9,8) | 5 subjects |
| MSB0010841 30 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 1 Swelling: mild (n=8,8,8,9,8) | 0 subjects |
| MSB0010841 30 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 1 Swelling: none (n=8,8,8,9,8) | 8 subjects |
| MSB0010841 30 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 30 Itching: none (n=8,8,7,7,8) | 8 subjects |
| MSB0010841 60 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 16 Bruising: none (n=8,8,8,8,8) | 7 subjects |
| MSB0010841 60 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 29 Bruising: none (n=8,8,8,7,8) | 8 subjects |
| MSB0010841 60 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 29 Indurations: none (n=8,8,7,7,8) | 8 subjects |
| MSB0010841 60 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 29 Itching: none (n=8,8,8,7,8) | 8 subjects |
| MSB0010841 60 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 15 Redness: none (n=8,8,8,8,8) | 7 subjects |
| MSB0010841 60 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 15 Redness: mild (n=8,8,8,8,8) | 1 subjects |
| MSB0010841 60 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 29 Redness: none (n=8,8,8,8,8) | 8 subjects |
| MSB0010841 60 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 29 Redness: mild (n=8,8,8,8,8) | 0 subjects |
| MSB0010841 60 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 29 Redness: moderate (n=8,8,8,8,8) | 0 subjects |
| MSB0010841 60 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 29 Swelling: none (n=8,8,8,7,8) | 8 subjects |
| MSB0010841 60 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 29 Swelling: mild (n=8,8,8,7,8) | 0 subjects |
| MSB0010841 60 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 30 Bruising: none (n=8,8,8,7,8) | 8 subjects |
| MSB0010841 60 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 30 Bruising: mild (n=8,8,8,7,8) | 0 subjects |
| MSB0010841 60 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 30 Indurations: none (n=8,8,7,7,8) | 8 subjects |
| MSB0010841 60 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 30 Itching: none (n=8,8,7,7,8) | 8 subjects |
| MSB0010841 60 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 30 Redness: none (n==8,8,7,7,8) | 8 subjects |
| MSB0010841 60 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 30 Redness: moderate (n=8,8,7,7,8) | 0 subjects |
| MSB0010841 60 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 30 Swelling: none (n=8,8,7,7,8) | 8 subjects |
| MSB0010841 60 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 36 Bruising: none (n=7,8,7,7,8) | 8 subjects |
| MSB0010841 60 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 36 Bruising: mild (n=7,8,7,7,8) | 0 subjects |
| MSB0010841 60 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 36 Indurations: none (n=8,8,7,7,7) | 8 subjects |
| MSB0010841 60 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 36 Itching: none (n=7,8,7,6,8) | 8 subjects |
| MSB0010841 60 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 43 Bruising: none (n=8,8,8,8,8) | 8 subjects |
| MSB0010841 60 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 43 Indurations: none (n=8,8,8,8,8) | 8 subjects |
| MSB0010841 60 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 15 Redness: moderate (n=8,8,8,8,8) | 0 subjects |
| MSB0010841 60 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 15 Swelling: none (n=8,8,8,8,8) | 8 subjects |
| MSB0010841 60 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 1 Itching: mild (n=8,8,8,9,8) | 0 subjects |
| MSB0010841 60 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 1 Redness: none (n=8,8,8,9,8) | 7 subjects |
| MSB0010841 60 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 1 Redness: mild (n=8,8,8,9,8) | 1 subjects |
| MSB0010841 60 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 1 Swelling: none (n=8,8,8,9,8) | 7 subjects |
| MSB0010841 60 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 1 Swelling: mild (n=8,8,8,9,8) | 1 subjects |
| MSB0010841 60 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 2 Bruising: none (n=8,8,8,9,8) | 8 subjects |
| MSB0010841 60 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 2 Bruising: mild (n=8,8,8,9,8) | 0 subjects |
| MSB0010841 60 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 2 Indurations: none (n=8,8,8,9,8) | 8 subjects |
| MSB0010841 60 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 2 Itching: none (n=8,8,8,9,8) | 8 subjects |
| MSB0010841 60 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 2 Redness: none (n=8,8,8,9,8) | 8 subjects |
| MSB0010841 60 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 2 Swelling: none (n=8,8,8,9,8) | 8 subjects |
| MSB0010841 60 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 8 Bruising: none (n=8,8,8,8,8) | 8 subjects |
| MSB0010841 60 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 8 Indurations: none (n=8,8,8,8,8) | 8 subjects |
| MSB0010841 60 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 8 Itching: none (n=8,8,8,8,8) | 8 subjects |
| MSB0010841 60 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 8 Redness: none (n=8,8,8,8,8) | 8 subjects |
| MSB0010841 60 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 8 Redness: mild (n=8,8,8,8,8) | 0 subjects |
| MSB0010841 60 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 8 Swelling: none (n=8,8,8,8,8) | 8 subjects |
| MSB0010841 60 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 16 Bruising: mild (n=8,8,8,8,8) | 1 subjects |
| MSB0010841 60 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 16 Indurations: none (n=8,8,8,8,8) | 8 subjects |
| MSB0010841 60 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 16 Itching: none (n=8,8,8,8,8) | 8 subjects |
| MSB0010841 60 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 16 Redness: none (n=8,8,8,8,8) | 8 subjects |
| MSB0010841 60 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 16 Redness: mild (n=8,8,8,8,8) | 0 subjects |
| MSB0010841 60 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 43 Itching: none (8,8,8,8,8) | 8 subjects |
| MSB0010841 60 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 43 Redness: none (n=8,8,8,8,8) | 8 subjects |
| MSB0010841 60 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 43 Redness: moderate (n=8,8,8,8,8) | 0 subjects |
| MSB0010841 60 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 43 Swelling: none (n=8,8,8,8,8) | 8 subjects |
| MSB0010841 60 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 1 Indurations: mild (n=8,8,8,9,8) | 0 subjects |
| MSB0010841 60 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 1 Bruising: none (n=8,8,8,9,8) | 8 subjects |
| MSB0010841 60 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 1 Indurations: none (n=8,8,8,9,8) | 8 subjects |
| MSB0010841 60 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 1 Itching: none (n=8,8,8,9,8) | 8 subjects |
| MSB0010841 60 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 16 Swelling: none (n=8,8,8,8,8) | 8 subjects |
| MSB0010841 60 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 16 Swelling: mild (n=8,8,8,8,8) | 0 subjects |
| MSB0010841 60 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 22 Bruising: none (n=8,8,8,8,8) | 8 subjects |
| MSB0010841 60 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 15 Bruising: none (n=8,8,8,8,8) | 8 subjects |
| MSB0010841 60 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 22 Bruising: mild (n=8,8,8,8,8) | 0 subjects |
| MSB0010841 60 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 22 Indurations: none (n=8,8,8,8,8) | 8 subjects |
| MSB0010841 60 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 15 Indurations: none (n=8,8,8,8,8) | 8 subjects |
| MSB0010841 60 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 22 Indurations: severe (n=8,8,8,8,8) | 0 subjects |
| MSB0010841 60 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 15 Itching: none (n=8,8,8,8,8) | 8 subjects |
| MSB0010841 60 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 22 Itching: none (n=8,8,8,8,8) | 8 subjects |
| MSB0010841 60 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 22 Itching: mild (n=8,8,8,8,8) | 0 subjects |
| MSB0010841 60 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 22 Redness: none (n=8,8,8,8,8) | 8 subjects |
| MSB0010841 60 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 22 Redness: severe (n=8,8,8,8,8) | 0 subjects |
| MSB0010841 60 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 22 Swelling: none (n=8,8,8,8,8) | 8 subjects |
| MSB0010841 60 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 22 Swelling: severe (n=8,8,8,8,8) | 0 subjects |
| MSB0010841 120 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 8 Swelling: none (n=8,8,8,8,8) | 8 subjects |
| MSB0010841 120 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 15 Redness: moderate (n=8,8,8,8,8) | 1 subjects |
| MSB0010841 120 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 22 Redness: none (n=8,8,8,8,8) | 7 subjects |
| MSB0010841 120 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 29 Swelling: none (n=8,8,8,7,8) | 7 subjects |
| MSB0010841 120 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 1 Indurations: mild (n=8,8,8,9,8) | 1 subjects |
| MSB0010841 120 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 1 Itching: mild (n=8,8,8,9,8) | 0 subjects |
| MSB0010841 120 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 1 Bruising: none (n=8,8,8,9,8) | 8 subjects |
| MSB0010841 120 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 15 Itching: none (n=8,8,8,8,8) | 8 subjects |
| MSB0010841 120 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 43 Indurations: none (n=8,8,8,8,8) | 8 subjects |
| MSB0010841 120 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 16 Bruising: none (n=8,8,8,8,8) | 8 subjects |
| MSB0010841 120 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 2 Indurations: none (n=8,8,8,9,8) | 8 subjects |
| MSB0010841 120 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 1 Indurations: none (n=8,8,8,9,8) | 7 subjects |
| MSB0010841 120 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 29 Redness: moderate (n=8,8,8,8,8) | 0 subjects |
| MSB0010841 120 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 30 Itching: none (n=8,8,7,7,8) | 0 subjects |
| MSB0010841 120 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 16 Bruising: mild (n=8,8,8,8,8) | 0 subjects |
| MSB0010841 120 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 22 Bruising: mild (n=8,8,8,8,8) | 0 subjects |
| MSB0010841 120 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 29 Redness: none (n=8,8,8,8,8) | 6 subjects |
| MSB0010841 120 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 30 Bruising: mild (n=8,8,8,7,8) | 1 subjects |
| MSB0010841 120 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 22 Itching: none (n=8,8,8,8,8) | 8 subjects |
| MSB0010841 120 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 16 Indurations: none (n=8,8,8,8,8) | 8 subjects |
| MSB0010841 120 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 22 Swelling: severe (n=8,8,8,8,8) | 1 subjects |
| MSB0010841 120 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 43 Swelling: none (n=8,8,8,8,8) | 8 subjects |
| MSB0010841 120 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 43 Redness: moderate (n=8,8,8,8,8) | 1 subjects |
| MSB0010841 120 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 2 Itching: none (n=8,8,8,9,8) | 8 subjects |
| MSB0010841 120 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 16 Itching: none (n=8,8,8,8,8) | 8 subjects |
| MSB0010841 120 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 22 Indurations: none (n=8,8,8,8,8) | 7 subjects |
| MSB0010841 120 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 15 Redness: mild (n=8,8,8,8,8) | 0 subjects |
| MSB0010841 120 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 43 Bruising: none (n=8,8,8,8,8) | 8 subjects |
| MSB0010841 120 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 43 Redness: none (n=8,8,8,8,8) | 7 subjects |
| MSB0010841 120 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 16 Redness: none (n=8,8,8,8,8) | 8 subjects |
| MSB0010841 120 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 30 Redness: moderate (n=8,8,7,7,8) | 0 subjects |
| MSB0010841 120 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 22 Itching: mild (n=8,8,8,8,8) | 0 subjects |
| MSB0010841 120 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 29 Redness: mild (n=8,8,8,8,8) | 2 subjects |
| MSB0010841 120 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 1 Swelling: mild (n=8,8,8,9,8) | 0 subjects |
| MSB0010841 120 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 16 Redness: mild (n=8,8,8,8,8) | 0 subjects |
| MSB0010841 120 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 43 Itching: none (8,8,8,8,8) | 8 subjects |
| MSB0010841 120 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 2 Redness: none (n=8,8,8,9,8) | 8 subjects |
| MSB0010841 120 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 1 Redness: none (n=8,8,8,9,8) | 8 subjects |
| MSB0010841 120 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 36 Itching: none (n=7,8,7,6,8) | 7 subjects |
| MSB0010841 120 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 29 Indurations: none (n=8,8,7,7,8) | 7 subjects |
| MSB0010841 120 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 36 Indurations: none (n=8,8,7,7,7) | 7 subjects |
| MSB0010841 120 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 2 Swelling: none (n=8,8,8,9,8) | 8 subjects |
| MSB0010841 120 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 30 Indurations: none (n=8,8,7,7,8) | 7 subjects |
| MSB0010841 120 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 36 Bruising: mild (n=7,8,7,7,8) | 0 subjects |
| MSB0010841 120 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 30 Bruising: none (n=8,8,8,7,8) | 7 subjects |
| MSB0010841 120 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 15 Indurations: none (n=8,8,8,8,8) | 8 subjects |
| MSB0010841 120 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 8 Bruising: none (n=8,8,8,8,8) | 8 subjects |
| MSB0010841 120 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 2 Bruising: none (n=8,8,8,9,8) | 8 subjects |
| MSB0010841 120 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 30 Swelling: none (n=8,8,7,7,8) | 7 subjects |
| MSB0010841 120 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 36 Bruising: none (n=7,8,7,7,8) | 7 subjects |
| MSB0010841 120 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 22 Swelling: none (n=8,8,8,8,8) | 7 subjects |
| MSB0010841 120 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 8 Indurations: none (n=8,8,8,8,8) | 8 subjects |
| MSB0010841 120 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 15 Bruising: none (n=8,8,8,8,8) | 8 subjects |
| MSB0010841 120 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 22 Redness: severe (n=8,8,8,8,8) | 1 subjects |
| MSB0010841 120 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 1 Swelling: none (n=8,8,8,9,8) | 8 subjects |
| MSB0010841 120 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 22 Indurations: severe (n=8,8,8,8,8) | 1 subjects |
| MSB0010841 120 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 8 Itching: none (n=8,8,8,8,8) | 8 subjects |
| MSB0010841 120 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 1 Itching: none (n=8,8,8,9,8) | 8 subjects |
| MSB0010841 120 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 22 Bruising: none (n=8,8,8,8,8) | 8 subjects |
| MSB0010841 120 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 29 Swelling: mild (n=8,8,8,7,8) | 1 subjects |
| MSB0010841 120 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 15 Swelling: none (n=8,8,8,8,8) | 8 subjects |
| MSB0010841 120 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 8 Redness: none (n=8,8,8,8,8) | 8 subjects |
| MSB0010841 120 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 30 Redness: none (n==8,8,7,7,8) | 7 subjects |
| MSB0010841 120 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 29 Itching: none (n=8,8,8,7,8) | 8 subjects |
| MSB0010841 120 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 16 Swelling: mild (n=8,8,8,8,8) | 1 subjects |
| MSB0010841 120 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 15 Redness: none (n=8,8,8,8,8) | 7 subjects |
| MSB0010841 120 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 8 Redness: mild (n=8,8,8,8,8) | 0 subjects |
| MSB0010841 120 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 2 Bruising: mild (n=8,8,8,9,8) | 0 subjects |
| MSB0010841 120 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 16 Swelling: none (n=8,8,8,8,8) | 7 subjects |
| MSB0010841 120 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 1 Redness: mild (n=8,8,8,9,8) | 0 subjects |
| MSB0010841 120 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 29 Bruising: none (n=8,8,8,7,8) | 8 subjects |
| MSB0010841 240 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 8 Indurations: none (n=8,8,8,8,8) | 8 subjects |
| MSB0010841 240 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 1 Redness: mild (n=8,8,8,9,8) | 1 subjects |
| MSB0010841 240 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 1 Swelling: none (n=8,8,8,9,8) | 9 subjects |
| MSB0010841 240 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 30 Indurations: none (n=8,8,7,7,8) | 7 subjects |
| MSB0010841 240 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 1 Swelling: mild (n=8,8,8,9,8) | 0 subjects |
| MSB0010841 240 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 22 Indurations: none (n=8,8,8,8,8) | 8 subjects |
| MSB0010841 240 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 2 Bruising: none (n=8,8,8,9,8) | 9 subjects |
| MSB0010841 240 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 2 Bruising: mild (n=8,8,8,9,8) | 0 subjects |
| MSB0010841 240 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 30 Bruising: mild (n=8,8,8,7,8) | 1 subjects |
| MSB0010841 240 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 2 Indurations: none (n=8,8,8,9,8) | 9 subjects |
| MSB0010841 240 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 2 Itching: none (n=8,8,8,9,8) | 9 subjects |
| MSB0010841 240 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 15 Indurations: none (n=8,8,8,8,8) | 8 subjects |
| MSB0010841 240 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 2 Redness: none (n=8,8,8,9,8) | 9 subjects |
| MSB0010841 240 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 30 Bruising: none (n=8,8,8,7,8) | 6 subjects |
| MSB0010841 240 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 2 Swelling: none (n=8,8,8,9,8) | 9 subjects |
| MSB0010841 240 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 29 Bruising: none (n=8,8,8,7,8) | 7 subjects |
| MSB0010841 240 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 8 Bruising: none (n=8,8,8,8,8) | 8 subjects |
| MSB0010841 240 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 29 Swelling: mild (n=8,8,8,7,8) | 0 subjects |
| MSB0010841 240 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 8 Itching: none (n=8,8,8,8,8) | 8 subjects |
| MSB0010841 240 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 22 Indurations: severe (n=8,8,8,8,8) | 0 subjects |
| MSB0010841 240 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 8 Redness: none (n=8,8,8,8,8) | 8 subjects |
| MSB0010841 240 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 8 Redness: mild (n=8,8,8,8,8) | 0 subjects |
| MSB0010841 240 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 29 Swelling: none (n=8,8,8,7,8) | 7 subjects |
| MSB0010841 240 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 8 Swelling: none (n=8,8,8,8,8) | 8 subjects |
| MSB0010841 240 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 15 Swelling: none (n=8,8,8,8,8) | 8 subjects |
| MSB0010841 240 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 29 Redness: moderate (n=8,8,8,8,8) | 1 subjects |
| MSB0010841 240 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 16 Bruising: none (n=8,8,8,8,8) | 7 subjects |
| MSB0010841 240 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 22 Swelling: none (n=8,8,8,8,8) | 8 subjects |
| MSB0010841 240 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 16 Bruising: mild (n=8,8,8,8,8) | 1 subjects |
| MSB0010841 240 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 15 Redness: mild (n=8,8,8,8,8) | 0 subjects |
| MSB0010841 240 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 16 Indurations: none (n=8,8,8,8,8) | 8 subjects |
| MSB0010841 240 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 22 Itching: none (n=8,8,8,8,8) | 8 subjects |
| MSB0010841 240 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 16 Itching: none (n=8,8,8,8,8) | 8 subjects |
| MSB0010841 240 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 29 Redness: mild (n=8,8,8,8,8) | 2 subjects |
| MSB0010841 240 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 16 Redness: none (n=8,8,8,8,8) | 8 subjects |
| MSB0010841 240 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 15 Itching: none (n=8,8,8,8,8) | 8 subjects |
| MSB0010841 240 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 43 Itching: none (8,8,8,8,8) | 8 subjects |
| MSB0010841 240 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 22 Itching: mild (n=8,8,8,8,8) | 0 subjects |
| MSB0010841 240 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 43 Redness: moderate (n=8,8,8,8,8) | 0 subjects |
| MSB0010841 240 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 29 Redness: none (n=8,8,8,8,8) | 5 subjects |
| MSB0010841 240 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 43 Swelling: none (n=8,8,8,8,8) | 8 subjects |
| MSB0010841 240 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 1 Indurations: none (n=8,8,8,9,8) | 9 subjects |
| MSB0010841 240 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 43 Redness: none (n=8,8,8,8,8) | 8 subjects |
| MSB0010841 240 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 1 Bruising: none (n=8,8,8,9,8) | 9 subjects |
| MSB0010841 240 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 1 Indurations: mild (n=8,8,8,9,8) | 0 subjects |
| MSB0010841 240 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 29 Itching: none (n=8,8,8,7,8) | 7 subjects |
| MSB0010841 240 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 16 Redness: mild (n=8,8,8,8,8) | 0 subjects |
| MSB0010841 240 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 22 Redness: none (n=8,8,8,8,8) | 8 subjects |
| MSB0010841 240 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 15 Redness: none (n=8,8,8,8,8) | 8 subjects |
| MSB0010841 240 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 16 Swelling: none (n=8,8,8,8,8) | 8 subjects |
| MSB0010841 240 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 16 Swelling: mild (n=8,8,8,8,8) | 0 subjects |
| MSB0010841 240 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 22 Swelling: severe (n=8,8,8,8,8) | 0 subjects |
| MSB0010841 240 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 15 Bruising: none (n=8,8,8,8,8) | 8 subjects |
| MSB0010841 240 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 30 Swelling: none (n=8,8,7,7,8) | 7 subjects |
| MSB0010841 240 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 36 Bruising: none (n=7,8,7,7,8) | 6 subjects |
| MSB0010841 240 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 22 Bruising: none (n=8,8,8,8,8) | 7 subjects |
| MSB0010841 240 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 36 Bruising: mild (n=7,8,7,7,8) | 1 subjects |
| MSB0010841 240 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 36 Indurations: none (n=8,8,7,7,7) | 7 subjects |
| MSB0010841 240 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 30 Redness: moderate (n=8,8,7,7,8) | 1 subjects |
| MSB0010841 240 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 29 Indurations: none (n=8,8,7,7,8) | 7 subjects |
| MSB0010841 240 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 36 Itching: none (n=7,8,7,6,8) | 6 subjects |
| MSB0010841 240 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 22 Redness: severe (n=8,8,8,8,8) | 0 subjects |
| MSB0010841 240 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 43 Bruising: none (n=8,8,8,8,8) | 8 subjects |
| MSB0010841 240 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 43 Indurations: none (n=8,8,8,8,8) | 8 subjects |
| MSB0010841 240 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 30 Redness: none (n==8,8,7,7,8) | 6 subjects |
| MSB0010841 240 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 22 Bruising: mild (n=8,8,8,8,8) | 1 subjects |
| MSB0010841 240 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 15 Redness: moderate (n=8,8,8,8,8) | 0 subjects |
| MSB0010841 240 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 1 Itching: none (n=8,8,8,9,8) | 8 subjects |
| MSB0010841 240 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 1 Itching: mild (n=8,8,8,9,8) | 1 subjects |
| MSB0010841 240 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 30 Itching: none (n=8,8,7,7,8) | 0 subjects |
| MSB0010841 240 mg | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 1 Redness: none (n=8,8,8,9,8) | 8 subjects |
| Placebo | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 1 Redness: mild (n=8,8,8,9,8) | 2 subjects |
| Placebo | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 16 Redness: mild (n=8,8,8,8,8) | 0 subjects |
| Placebo | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 15 Redness: mild (n=8,8,8,8,8) | 0 subjects |
| Placebo | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 22 Redness: none (n=8,8,8,8,8) | 8 subjects |
| Placebo | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 1 Itching: mild (n=8,8,8,9,8) | 0 subjects |
| Placebo | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 16 Swelling: none (n=8,8,8,8,8) | 8 subjects |
| Placebo | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 22 Indurations: severe (n=8,8,8,8,8) | 0 subjects |
| Placebo | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 22 Swelling: severe (n=8,8,8,8,8) | 0 subjects |
| Placebo | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 29 Swelling: none (n=8,8,8,7,8) | 8 subjects |
| Placebo | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 1 Redness: none (n=8,8,8,9,8) | 6 subjects |
| Placebo | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 16 Swelling: mild (n=8,8,8,8,8) | 0 subjects |
| Placebo | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 8 Redness: none (n=8,8,8,8,8) | 8 subjects |
| Placebo | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 2 Bruising: mild (n=8,8,8,9,8) | 0 subjects |
| Placebo | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 8 Itching: none (n=8,8,8,8,8) | 8 subjects |
| Placebo | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 8 Indurations: none (n=8,8,8,8,8) | 8 subjects |
| Placebo | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 15 Itching: none (n=8,8,8,8,8) | 8 subjects |
| Placebo | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 22 Redness: severe (n=8,8,8,8,8) | 0 subjects |
| Placebo | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 15 Bruising: none (n=8,8,8,8,8) | 8 subjects |
| Placebo | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 30 Swelling: none (n=8,8,7,7,8) | 8 subjects |
| Placebo | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 15 Redness: moderate (n=8,8,8,8,8) | 0 subjects |
| Placebo | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 29 Indurations: none (n=8,8,7,7,8) | 8 subjects |
| Placebo | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 29 Swelling: mild (n=8,8,8,7,8) | 0 subjects |
| Placebo | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 22 Indurations: none (n=8,8,8,8,8) | 8 subjects |
| Placebo | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 36 Bruising: none (n=7,8,7,7,8) | 8 subjects |
| Placebo | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 8 Bruising: none (n=8,8,8,8,8) | 8 subjects |
| Placebo | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 22 Bruising: mild (n=8,8,8,8,8) | 0 subjects |
| Placebo | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 2 Swelling: none (n=8,8,8,9,8) | 8 subjects |
| Placebo | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 30 Bruising: mild (n=8,8,8,7,8) | 0 subjects |
| Placebo | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 36 Bruising: mild (n=7,8,7,7,8) | 0 subjects |
| Placebo | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 30 Redness: moderate (n=8,8,7,7,8) | 0 subjects |
| Placebo | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 22 Bruising: none (n=8,8,8,8,8) | 8 subjects |
| Placebo | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 15 Indurations: none (n=8,8,8,8,8) | 8 subjects |
| Placebo | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 2 Bruising: none (n=8,8,8,9,8) | 8 subjects |
| Placebo | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 36 Indurations: none (n=8,8,7,7,7) | 7 subjects |
| Placebo | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 30 Indurations: none (n=8,8,7,7,8) | 8 subjects |
| Placebo | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 1 Itching: none (n=8,8,8,9,8) | 9 subjects |
| Placebo | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 22 Swelling: none (n=8,8,8,8,8) | 8 subjects |
| Placebo | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 2 Redness: none (n=8,8,8,9,8) | 8 subjects |
| Placebo | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 43 Itching: none (8,8,8,8,8) | 8 subjects |
| Placebo | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 29 Redness: none (n=8,8,8,8,8) | 8 subjects |
| Placebo | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 16 Redness: none (n=8,8,8,8,8) | 8 subjects |
| Placebo | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 22 Itching: none (n=8,8,8,8,8) | 8 subjects |
| Placebo | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 43 Redness: none (n=8,8,8,8,8) | 8 subjects |
| Placebo | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 16 Itching: none (n=8,8,8,8,8) | 8 subjects |
| Placebo | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 30 Itching: none (n=8,8,7,7,8) | 8 subjects |
| Placebo | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 29 Redness: mild (n=8,8,8,8,8) | 0 subjects |
| Placebo | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 36 Itching: none (n=7,8,7,6,8) | 8 subjects |
| Placebo | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 43 Redness: moderate (n=8,8,8,8,8) | 0 subjects |
| Placebo | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 30 Bruising: none (n=8,8,8,7,8) | 8 subjects |
| Placebo | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 22 Itching: mild (n=8,8,8,8,8) | 0 subjects |
| Placebo | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 16 Indurations: none (n=8,8,8,8,8) | 8 subjects |
| Placebo | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 1 Swelling: mild (n=8,8,8,9,8) | 0 subjects |
| Placebo | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 43 Swelling: none (n=8,8,8,8,8) | 8 subjects |
| Placebo | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 16 Bruising: mild (n=8,8,8,8,8) | 0 subjects |
| Placebo | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 16 Bruising: none (n=8,8,8,8,8) | 8 subjects |
| Placebo | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 2 Itching: none (n=8,8,8,9,8) | 8 subjects |
| Placebo | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 1 Indurations: none (n=8,8,8,9,8) | 8 subjects |
| Placebo | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 29 Itching: none (n=8,8,8,7,8) | 8 subjects |
| Placebo | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 29 Redness: moderate (n=8,8,8,8,8) | 0 subjects |
| Placebo | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 1 Swelling: none (n=8,8,8,9,8) | 8 subjects |
| Placebo | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 15 Swelling: none (n=8,8,8,8,8) | 8 subjects |
| Placebo | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 43 Bruising: none (n=8,8,8,8,8) | 8 subjects |
| Placebo | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 43 Indurations: none (n=8,8,8,8,8) | 8 subjects |
| Placebo | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 30 Redness: none (n==8,8,7,7,8) | 8 subjects |
| Placebo | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 1 Bruising: none (n=8,8,8,9,8) | 8 subjects |
| Placebo | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 2 Indurations: none (n=8,8,8,9,8) | 8 subjects |
| Placebo | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 8 Swelling: none (n=8,8,8,8,8) | 8 subjects |
| Placebo | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 29 Bruising: none (n=8,8,8,7,8) | 8 subjects |
| Placebo | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 8 Redness: mild (n=8,8,8,8,8) | 0 subjects |
| Placebo | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 1 Indurations: mild (n=8,8,8,9,8) | 0 subjects |
| Placebo | Number of Subjects With Local Injection Site Reactions (ISRs) | Day 15 Redness: none (n=8,8,8,8,8) | 8 subjects |
Number of Subjects With Treatment Emergent Adverse Events (TEAEs)
An adverse event (AE) was defined as any untoward medical occurrence which does not necessarily have a causal relationship with this the study drug. An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug or worsening of pre-existing medical condition, whether or not related to study drug. TEAEs were the AEs occurring or worsening after treatment administration.
Time frame: Baseline up to Day 85
Population: Safety analysis set included all 41 subjects who received at least 1 dose of IMP (MSB0010841 or placebo).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MSB0010841 30 mg | Number of Subjects With Treatment Emergent Adverse Events (TEAEs) | 6 subjects |
| MSB0010841 60 mg | Number of Subjects With Treatment Emergent Adverse Events (TEAEs) | 5 subjects |
| MSB0010841 120 mg | Number of Subjects With Treatment Emergent Adverse Events (TEAEs) | 5 subjects |
| MSB0010841 240 mg | Number of Subjects With Treatment Emergent Adverse Events (TEAEs) | 6 subjects |
| Placebo | Number of Subjects With Treatment Emergent Adverse Events (TEAEs) | 6 subjects |
Observed Serum Concentration Immediately Before First Dose (Cpre) of MSB0010841
The observed serum concentration immediately before the first dose.
Time frame: Pre-dose (0 hours) on Day 1
Population: PK analysis set included subjects who received active treatment (MSB0010841) without protocol deviations affecting PK, and who provide evaluable PK data. Here Number of participants analyzed signifies those subjects who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MSB0010841 30 mg | Observed Serum Concentration Immediately Before First Dose (Cpre) of MSB0010841 | 0.01 mcg/mL | Standard Deviation 0.036 |
| MSB0010841 60 mg | Observed Serum Concentration Immediately Before First Dose (Cpre) of MSB0010841 | 0.00 mcg/mL | Standard Deviation 0 |
| MSB0010841 120 mg | Observed Serum Concentration Immediately Before First Dose (Cpre) of MSB0010841 | 0.00 mcg/mL | Standard Deviation 0 |
| MSB0010841 240 mg | Observed Serum Concentration Immediately Before First Dose (Cpre) of MSB0010841 | 0.00 mcg/mL | Standard Deviation 0 |
Observed Serum Concentration Immediately Before Second Dose (Cpre) of MSB0010841
The observed serum concentration immediately before second dose.
Time frame: Pre-dose (0 hours) on Day 15
Population: PK analysis set included subjects who received active treatment (MSB0010841) without protocol deviations affecting PK, and who provide evaluable PK data. Here Number of participants analyzed signifies those subjects who were evaluable for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| MSB0010841 30 mg | Observed Serum Concentration Immediately Before Second Dose (Cpre) of MSB0010841 | 1.65 mcg/mL | Geometric Coefficient of Variation 30.2 |
| MSB0010841 60 mg | Observed Serum Concentration Immediately Before Second Dose (Cpre) of MSB0010841 | 3.74 mcg/mL | Geometric Coefficient of Variation 37.9 |
| MSB0010841 120 mg | Observed Serum Concentration Immediately Before Second Dose (Cpre) of MSB0010841 | 6.34 mcg/mL | Geometric Coefficient of Variation 38.3 |
| MSB0010841 240 mg | Observed Serum Concentration Immediately Before Second Dose (Cpre) of MSB0010841 | 11.44 mcg/mL | Geometric Coefficient of Variation 18.1 |
Observed Serum Concentration Immediately Before Third Dose (Cpre) of MSB0010841
The observed serum concentration immediately before the third dose.
Time frame: Pre-dose (0 hours) on Day 29
Population: PK analysis set included subjects who received active treatment (MSB0010841) without protocol deviations affecting PK, and who provide evaluable PK data. Here Number of participants analyzed signifies those subjects who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MSB0010841 30 mg | Observed Serum Concentration Immediately Before Third Dose (Cpre) of MSB0010841 | 2.31 mcg/mL | Standard Deviation 0.59 |
| MSB0010841 60 mg | Observed Serum Concentration Immediately Before Third Dose (Cpre) of MSB0010841 | 4.49 mcg/mL | Standard Deviation 1.4 |
| MSB0010841 120 mg | Observed Serum Concentration Immediately Before Third Dose (Cpre) of MSB0010841 | 10.42 mcg/mL | Standard Deviation 4.72 |
| MSB0010841 240 mg | Observed Serum Concentration Immediately Before Third Dose (Cpre) of MSB0010841 | 16.17 mcg/mL | Standard Deviation 4.84 |
Percentage of Subjects With Anti-MSB0010841 Binding Antibodies (Anti-Drug Antibodies [ADA])
Data were presented for MSB0010841 combined group and placebo.
Time frame: Baseline up to Day 85
Population: Safety analysis set included all 41 subjects who received at least one dose of IMP (MSB0010841 or placebo).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MSB0010841 30 mg | Percentage of Subjects With Anti-MSB0010841 Binding Antibodies (Anti-Drug Antibodies [ADA]) | 30.3 percentage of subjects |
| MSB0010841 60 mg | Percentage of Subjects With Anti-MSB0010841 Binding Antibodies (Anti-Drug Antibodies [ADA]) | 37.5 percentage of subjects |
Percentage Peak-Trough Fluctuation (PTF) Post First Dose of MSB0010841
The peak trough fluctuation within one dosing interval, calculated as PTF (%) = (\[Cmax - Cmin\]/Cav ) multiplied by 100
Time frame: 0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336 hours post-first dose (Day 1)
Population: PK analysis set included subjects who received active treatment (MSB0010841) without protocol deviations affecting PK, and who provide evaluable PK data. Here Number of subjects analyzed signifies those subjects who were evaluable for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| MSB0010841 30 mg | Percentage Peak-Trough Fluctuation (PTF) Post First Dose of MSB0010841 | 140.28 percentage fluctuation | Geometric Coefficient of Variation 3.9 |
| MSB0010841 60 mg | Percentage Peak-Trough Fluctuation (PTF) Post First Dose of MSB0010841 | 152.47 percentage fluctuation | Geometric Coefficient of Variation 20.4 |
| MSB0010841 120 mg | Percentage Peak-Trough Fluctuation (PTF) Post First Dose of MSB0010841 | 144.37 percentage fluctuation | Geometric Coefficient of Variation 13 |
| MSB0010841 240 mg | Percentage Peak-Trough Fluctuation (PTF) Post First Dose of MSB0010841 | 135.89 percentage fluctuation | Geometric Coefficient of Variation 12.3 |
Percentage Peak-Trough Fluctuation (PTF) Post Third Dose of MSB0010841
The peak trough fluctuation within one dosing interval, calculated as PTF (%) = (\[Cmax - Cmin\]/Cav ) multiplied by 100
Time frame: 0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336, 504, 816, 1056, 1344 hours post-third dose (Day 29)
Population: PK analysis set included subjects who received active treatment (MSB0010841) without protocol deviations affecting PK, and who provide evaluable PK data. Here Number of subjects analyzed signifies those subjects who were evaluable for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| MSB0010841 30 mg | Percentage Peak-Trough Fluctuation (PTF) Post Third Dose of MSB0010841 | 75.26 percentage fluctuation | Geometric Coefficient of Variation 8.5 |
| MSB0010841 60 mg | Percentage Peak-Trough Fluctuation (PTF) Post Third Dose of MSB0010841 | 95.65 percentage fluctuation | Geometric Coefficient of Variation 18.9 |
| MSB0010841 120 mg | Percentage Peak-Trough Fluctuation (PTF) Post Third Dose of MSB0010841 | 71.17 percentage fluctuation | Geometric Coefficient of Variation 33.1 |
| MSB0010841 240 mg | Percentage Peak-Trough Fluctuation (PTF) Post Third Dose of MSB0010841 | 76.03 percentage fluctuation | Geometric Coefficient of Variation 28.6 |
Terminal Rate Constant (λz) Post Third Dose of MSB0010841
Terminal rate constant was determined from the terminal slope of the logtransformed concentration curve using linear regression on terminal data points of the curve
Time frame: 0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336, 504, 816, 1056, 1344 hours post-third dose (Day 29)
Population: PK analysis set included subjects who received active treatment (MSB0010841) without protocol deviations affecting PK, and who provide evaluable PK data. Here Number of participants analyzed signifies those subjects who were evaluable for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| MSB0010841 30 mg | Terminal Rate Constant (λz) Post Third Dose of MSB0010841 | 0.00 1/hour | Geometric Coefficient of Variation 17.3 |
| MSB0010841 60 mg | Terminal Rate Constant (λz) Post Third Dose of MSB0010841 | 0.00 1/hour | Geometric Coefficient of Variation 18.9 |
| MSB0010841 120 mg | Terminal Rate Constant (λz) Post Third Dose of MSB0010841 | 0.00 1/hour | Geometric Coefficient of Variation 27.9 |
| MSB0010841 240 mg | Terminal Rate Constant (λz) Post Third Dose of MSB0010841 | 0.00 1/hour | Geometric Coefficient of Variation 13.1 |
Time to Maximum Observed Concentration (Tmax) Post Second Dose of MSB0010841
Time frame: 0 hours (pre-dose), 24, 72, 96, 168, 336 hours post-second dose (Day 15)
Population: PK analysis set included subjects who received active treatment (MSB0010841) without protocol deviations affecting PK, and who provide evaluable PK data. Here Number of participants analyzed signifies those subjects who were evaluable for this outcome measure.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| MSB0010841 30 mg | Time to Maximum Observed Concentration (Tmax) Post Second Dose of MSB0010841 | 84.2 hour |
| MSB0010841 60 mg | Time to Maximum Observed Concentration (Tmax) Post Second Dose of MSB0010841 | 72.0 hour |
| MSB0010841 120 mg | Time to Maximum Observed Concentration (Tmax) Post Second Dose of MSB0010841 | 83.4 hour |
| MSB0010841 240 mg | Time to Maximum Observed Concentration (Tmax) Post Second Dose of MSB0010841 | 72.0 hour |
Time to Reach Maximum Observed Concentration (Tmax) Post First Dose of MSB0010841
Time frame: 0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336 hours post-first dose (Day 1)
Population: PK analysis set included subjects who received active treatment (MSB0010841) without protocol deviations affecting PK, and who provide evaluable PK data. Here Number of participants analyzed signifies those subjects who were evaluable for this outcome measure.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| MSB0010841 30 mg | Time to Reach Maximum Observed Concentration (Tmax) Post First Dose of MSB0010841 | 72.39 hour |
| MSB0010841 60 mg | Time to Reach Maximum Observed Concentration (Tmax) Post First Dose of MSB0010841 | 71.68 hour |
| MSB0010841 120 mg | Time to Reach Maximum Observed Concentration (Tmax) Post First Dose of MSB0010841 | 52.00 hour |
| MSB0010841 240 mg | Time to Reach Maximum Observed Concentration (Tmax) Post First Dose of MSB0010841 | 72.23 hour |
Time to Reach Maximum Observed Concentration (Tmax) Post Third Dose of MSB0010841
Time frame: 0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336, 504, 816, 1056, 1344 hours post-third dose (Day 29)
Population: PK analysis set included subjects who received active treatment (MSB0010841) without protocol deviations affecting PK, and who provide evaluable PK data. Here Number of participants analyzed signifies those subjects who were evaluable for this outcome measure.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| MSB0010841 30 mg | Time to Reach Maximum Observed Concentration (Tmax) Post Third Dose of MSB0010841 | 31.5 hour |
| MSB0010841 60 mg | Time to Reach Maximum Observed Concentration (Tmax) Post Third Dose of MSB0010841 | 31.0 hour |
| MSB0010841 120 mg | Time to Reach Maximum Observed Concentration (Tmax) Post Third Dose of MSB0010841 | 72.0 hour |
| MSB0010841 240 mg | Time to Reach Maximum Observed Concentration (Tmax) Post Third Dose of MSB0010841 | 72.0 hour |
Mean Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Day 43
PASI: a physician assessed index that measured psoriasis severity and evaluated erythema, infiltration, and desquamation (scaling) on different body areas including the head, upper extremities, the trunk, and lower extremities. T Erythema, infiltration, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The total qualitative score (sum of erythema, thickness, and scaling scores) was multiplied by the degree of involvement for each anatomic region and then multiplied by a constant. These values for each anatomic region are summed to yield the PASI score. PASI score ranged from 0 to 72, with higher scores reflecting greater disease severity. PASI 50% or 75% was defined as the percentage of subjects who achieved \>=50 or 75% improvement in PASI score from Baseline.
Time frame: Baseline, Day 43
Population: Safety analysis set included all 41 subjects who received at least one dose of IMP (MSB0010841 or placebo).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MSB0010841 30 mg | Mean Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Day 43 | Baseline | 16.91 units on a scale | Standard Deviation 5.75 |
| MSB0010841 30 mg | Mean Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Day 43 | Change at Day 43 | -13.93 units on a scale | Standard Deviation 4.76 |
| MSB0010841 60 mg | Mean Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Day 43 | Baseline | 19.76 units on a scale | Standard Deviation 4.79 |
| MSB0010841 60 mg | Mean Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Day 43 | Change at Day 43 | -17.99 units on a scale | Standard Deviation 5.52 |
| MSB0010841 120 mg | Mean Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Day 43 | Baseline | 23.35 units on a scale | Standard Deviation 6.6 |
| MSB0010841 120 mg | Mean Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Day 43 | Change at Day 43 | -21.70 units on a scale | Standard Deviation 8.52 |
| MSB0010841 240 mg | Mean Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Day 43 | Change at Day 43 | -16.68 units on a scale | Standard Deviation 8.38 |
| MSB0010841 240 mg | Mean Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Day 43 | Baseline | 18.38 units on a scale | Standard Deviation 6.07 |
| Placebo | Mean Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Day 43 | Baseline | 25.49 units on a scale | Standard Deviation 5.58 |
| Placebo | Mean Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Day 43 | Change at Day 43 | -5.43 units on a scale | Standard Deviation 7.04 |
Mean Percent Change From Baseline in the Body Surface Area (BSA) Affected by Psoriasis at Day 8, 15, 22, 29, 36, 43, 50 and 85
The BSA is the physician's evaluation for the extent of disease. The entire body area is divided into 4 districts: head, upper limbs, trunk and lower limbs to which corresponds the 10%, 20%, 30% and 40% of the entire body surface respectively. The investigator assesses the percentage of the subjects' body surface area affected by psoriasis in each district. The final affected BSA value is the sum of the percentage of each district.
Time frame: Baseline, Day 8, 15, 22, 29, 36, 43, 50 and 85
Population: Safety analysis set included all 41 subjects who received at least 1 dose of IMP (MSB0010841 or placebo). Here n signifies those subjects who were evaluable for this outcome measure at the specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MSB0010841 30 mg | Mean Percent Change From Baseline in the Body Surface Area (BSA) Affected by Psoriasis at Day 8, 15, 22, 29, 36, 43, 50 and 85 | Change at Day 43 (8,8,8,9,8) | -52.6 percent change | Standard Deviation 32.91 |
| MSB0010841 30 mg | Mean Percent Change From Baseline in the Body Surface Area (BSA) Affected by Psoriasis at Day 8, 15, 22, 29, 36, 43, 50 and 85 | Change at Day 22 (n=8,8,8,8,8) | -11.6 percent change | Standard Deviation 24.9 |
| MSB0010841 30 mg | Mean Percent Change From Baseline in the Body Surface Area (BSA) Affected by Psoriasis at Day 8, 15, 22, 29, 36, 43, 50 and 85 | Change at Day 8 (n=8,8,8,8,8) | 0.4 percent change | Standard Deviation 1.14 |
| MSB0010841 30 mg | Mean Percent Change From Baseline in the Body Surface Area (BSA) Affected by Psoriasis at Day 8, 15, 22, 29, 36, 43, 50 and 85 | Change at Day 85 (8,8,8,9,8) | -60.4 percent change | Standard Deviation 33.51 |
| MSB0010841 30 mg | Mean Percent Change From Baseline in the Body Surface Area (BSA) Affected by Psoriasis at Day 8, 15, 22, 29, 36, 43, 50 and 85 | Change at Day 36 (8,8,7,7,7) | -31.4 percent change | Standard Deviation 22.96 |
| MSB0010841 30 mg | Mean Percent Change From Baseline in the Body Surface Area (BSA) Affected by Psoriasis at Day 8, 15, 22, 29, 36, 43, 50 and 85 | Change at Day 29 (n=8,8,8,8,8) | -22.6 percent change | Standard Deviation 26.35 |
| MSB0010841 30 mg | Mean Percent Change From Baseline in the Body Surface Area (BSA) Affected by Psoriasis at Day 8, 15, 22, 29, 36, 43, 50 and 85 | Change at Day 50 (n=8,8,8,9,8) | -56.2 percent change | Standard Deviation 34.71 |
| MSB0010841 30 mg | Mean Percent Change From Baseline in the Body Surface Area (BSA) Affected by Psoriasis at Day 8, 15, 22, 29, 36, 43, 50 and 85 | Change at Day 15 (n=8,8,8,8,8) | 0.4 percent change | Standard Deviation 1.14 |
| MSB0010841 60 mg | Mean Percent Change From Baseline in the Body Surface Area (BSA) Affected by Psoriasis at Day 8, 15, 22, 29, 36, 43, 50 and 85 | Change at Day 36 (8,8,7,7,7) | -52.7 percent change | Standard Deviation 37.57 |
| MSB0010841 60 mg | Mean Percent Change From Baseline in the Body Surface Area (BSA) Affected by Psoriasis at Day 8, 15, 22, 29, 36, 43, 50 and 85 | Change at Day 43 (8,8,8,9,8) | -65.2 percent change | Standard Deviation 28.61 |
| MSB0010841 60 mg | Mean Percent Change From Baseline in the Body Surface Area (BSA) Affected by Psoriasis at Day 8, 15, 22, 29, 36, 43, 50 and 85 | Change at Day 85 (8,8,8,9,8) | -61.3 percent change | Standard Deviation 33.89 |
| MSB0010841 60 mg | Mean Percent Change From Baseline in the Body Surface Area (BSA) Affected by Psoriasis at Day 8, 15, 22, 29, 36, 43, 50 and 85 | Change at Day 15 (n=8,8,8,8,8) | -33.1 percent change | Standard Deviation 35.97 |
| MSB0010841 60 mg | Mean Percent Change From Baseline in the Body Surface Area (BSA) Affected by Psoriasis at Day 8, 15, 22, 29, 36, 43, 50 and 85 | Change at Day 22 (n=8,8,8,8,8) | -40.2 percent change | Standard Deviation 40.68 |
| MSB0010841 60 mg | Mean Percent Change From Baseline in the Body Surface Area (BSA) Affected by Psoriasis at Day 8, 15, 22, 29, 36, 43, 50 and 85 | Change at Day 8 (n=8,8,8,8,8) | -30.0 percent change | Standard Deviation 31.23 |
| MSB0010841 60 mg | Mean Percent Change From Baseline in the Body Surface Area (BSA) Affected by Psoriasis at Day 8, 15, 22, 29, 36, 43, 50 and 85 | Change at Day 29 (n=8,8,8,8,8) | -44.1 percent change | Standard Deviation 42.53 |
| MSB0010841 60 mg | Mean Percent Change From Baseline in the Body Surface Area (BSA) Affected by Psoriasis at Day 8, 15, 22, 29, 36, 43, 50 and 85 | Change at Day 50 (n=8,8,8,9,8) | -69.4 percent change | Standard Deviation 25.85 |
| MSB0010841 120 mg | Mean Percent Change From Baseline in the Body Surface Area (BSA) Affected by Psoriasis at Day 8, 15, 22, 29, 36, 43, 50 and 85 | Change at Day 50 (n=8,8,8,9,8) | -79.1 percent change | Standard Deviation 32.3 |
| MSB0010841 120 mg | Mean Percent Change From Baseline in the Body Surface Area (BSA) Affected by Psoriasis at Day 8, 15, 22, 29, 36, 43, 50 and 85 | Change at Day 43 (8,8,8,9,8) | -75.4 percent change | Standard Deviation 37.35 |
| MSB0010841 120 mg | Mean Percent Change From Baseline in the Body Surface Area (BSA) Affected by Psoriasis at Day 8, 15, 22, 29, 36, 43, 50 and 85 | Change at Day 85 (8,8,8,9,8) | -82.1 percent change | Standard Deviation 31.05 |
| MSB0010841 120 mg | Mean Percent Change From Baseline in the Body Surface Area (BSA) Affected by Psoriasis at Day 8, 15, 22, 29, 36, 43, 50 and 85 | Change at Day 29 (n=8,8,8,8,8) | -55.9 percent change | Standard Deviation 36.56 |
| MSB0010841 120 mg | Mean Percent Change From Baseline in the Body Surface Area (BSA) Affected by Psoriasis at Day 8, 15, 22, 29, 36, 43, 50 and 85 | Change at Day 15 (n=8,8,8,8,8) | -20.5 percent change | Standard Deviation 10.98 |
| MSB0010841 120 mg | Mean Percent Change From Baseline in the Body Surface Area (BSA) Affected by Psoriasis at Day 8, 15, 22, 29, 36, 43, 50 and 85 | Change at Day 8 (n=8,8,8,8,8) | -13.7 percent change | Standard Deviation 15.13 |
| MSB0010841 120 mg | Mean Percent Change From Baseline in the Body Surface Area (BSA) Affected by Psoriasis at Day 8, 15, 22, 29, 36, 43, 50 and 85 | Change at Day 22 (n=8,8,8,8,8) | -42.6 percent change | Standard Deviation 27.15 |
| MSB0010841 120 mg | Mean Percent Change From Baseline in the Body Surface Area (BSA) Affected by Psoriasis at Day 8, 15, 22, 29, 36, 43, 50 and 85 | Change at Day 36 (8,8,7,7,7) | -64.6 percent change | Standard Deviation 37.65 |
| MSB0010841 240 mg | Mean Percent Change From Baseline in the Body Surface Area (BSA) Affected by Psoriasis at Day 8, 15, 22, 29, 36, 43, 50 and 85 | Change at Day 50 (n=8,8,8,9,8) | -82.2 percent change | Standard Deviation 36.64 |
| MSB0010841 240 mg | Mean Percent Change From Baseline in the Body Surface Area (BSA) Affected by Psoriasis at Day 8, 15, 22, 29, 36, 43, 50 and 85 | Change at Day 8 (n=8,8,8,8,8) | -12.5 percent change | Standard Deviation 23.81 |
| MSB0010841 240 mg | Mean Percent Change From Baseline in the Body Surface Area (BSA) Affected by Psoriasis at Day 8, 15, 22, 29, 36, 43, 50 and 85 | Change at Day 15 (n=8,8,8,8,8) | -51.1 percent change | Standard Deviation 43.17 |
| MSB0010841 240 mg | Mean Percent Change From Baseline in the Body Surface Area (BSA) Affected by Psoriasis at Day 8, 15, 22, 29, 36, 43, 50 and 85 | Change at Day 22 (n=8,8,8,8,8) | -68.5 percent change | Standard Deviation 38.71 |
| MSB0010841 240 mg | Mean Percent Change From Baseline in the Body Surface Area (BSA) Affected by Psoriasis at Day 8, 15, 22, 29, 36, 43, 50 and 85 | Change at Day 29 (n=8,8,8,8,8) | -82.9 percent change | Standard Deviation 34.46 |
| MSB0010841 240 mg | Mean Percent Change From Baseline in the Body Surface Area (BSA) Affected by Psoriasis at Day 8, 15, 22, 29, 36, 43, 50 and 85 | Change at Day 36 (8,8,7,7,7) | -83.5 percent change | Standard Deviation 31.6 |
| MSB0010841 240 mg | Mean Percent Change From Baseline in the Body Surface Area (BSA) Affected by Psoriasis at Day 8, 15, 22, 29, 36, 43, 50 and 85 | Change at Day 43 (8,8,8,9,8) | -82.2 percent change | Standard Deviation 36.64 |
| MSB0010841 240 mg | Mean Percent Change From Baseline in the Body Surface Area (BSA) Affected by Psoriasis at Day 8, 15, 22, 29, 36, 43, 50 and 85 | Change at Day 85 (8,8,8,9,8) | -95.5 percent change | Standard Deviation 11.02 |
| Placebo | Mean Percent Change From Baseline in the Body Surface Area (BSA) Affected by Psoriasis at Day 8, 15, 22, 29, 36, 43, 50 and 85 | Change at Day 36 (8,8,7,7,7) | -0.5 percent change | Standard Deviation 27.92 |
| Placebo | Mean Percent Change From Baseline in the Body Surface Area (BSA) Affected by Psoriasis at Day 8, 15, 22, 29, 36, 43, 50 and 85 | Change at Day 29 (n=8,8,8,8,8) | -0.1 percent change | Standard Deviation 26.13 |
| Placebo | Mean Percent Change From Baseline in the Body Surface Area (BSA) Affected by Psoriasis at Day 8, 15, 22, 29, 36, 43, 50 and 85 | Change at Day 22 (n=8,8,8,8,8) | -5.1 percent change | Standard Deviation 12.69 |
| Placebo | Mean Percent Change From Baseline in the Body Surface Area (BSA) Affected by Psoriasis at Day 8, 15, 22, 29, 36, 43, 50 and 85 | Change at Day 15 (n=8,8,8,8,8) | -4.2 percent change | Standard Deviation 12.21 |
| Placebo | Mean Percent Change From Baseline in the Body Surface Area (BSA) Affected by Psoriasis at Day 8, 15, 22, 29, 36, 43, 50 and 85 | Change at Day 8 (n=8,8,8,8,8) | 2.9 percent change | Standard Deviation 23.32 |
| Placebo | Mean Percent Change From Baseline in the Body Surface Area (BSA) Affected by Psoriasis at Day 8, 15, 22, 29, 36, 43, 50 and 85 | Change at Day 50 (n=8,8,8,9,8) | -10.0 percent change | Standard Deviation 17.87 |
| Placebo | Mean Percent Change From Baseline in the Body Surface Area (BSA) Affected by Psoriasis at Day 8, 15, 22, 29, 36, 43, 50 and 85 | Change at Day 85 (8,8,8,9,8) | -13.0 percent change | Standard Deviation 20.13 |
| Placebo | Mean Percent Change From Baseline in the Body Surface Area (BSA) Affected by Psoriasis at Day 8, 15, 22, 29, 36, 43, 50 and 85 | Change at Day 43 (8,8,8,9,8) | -1.5 percent change | Standard Deviation 27.05 |
Percentage of Subjects With 50% or 75% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score
PASI: a physician assessed index that measured psoriasis severity and evaluated erythema, infiltration, and desquamation (scaling) on different body areas including the head, upper extremities, the trunk, and lower extremities. T Erythema, infiltration, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The total qualitative score (sum of erythema, thickness, and scaling scores) was multiplied by the degree of involvement for each anatomic region and then multiplied by a constant. These values for each anatomic region are summed to yield the PASI score. PASI score ranged from 0 to 72, with higher scores reflecting greater disease severity. PASI 50% or 75% was defined as the percentage of participants who achieved \>=50 or 75% improvement in PASI score from Baseline.
Time frame: Baseline up to Day 85
Population: Safety analysis set included all 41 subjects who received at least 1 dose of IMP (MSB0010841 or placebo).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MSB0010841 30 mg | Percentage of Subjects With 50% or 75% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score | PASI-50 | 100 percentage of subjects |
| MSB0010841 30 mg | Percentage of Subjects With 50% or 75% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score | PASI-75 | 88 percentage of subjects |
| MSB0010841 60 mg | Percentage of Subjects With 50% or 75% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score | PASI-75 | 100 percentage of subjects |
| MSB0010841 60 mg | Percentage of Subjects With 50% or 75% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score | PASI-50 | 100 percentage of subjects |
| MSB0010841 120 mg | Percentage of Subjects With 50% or 75% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score | PASI-75 | 100 percentage of subjects |
| MSB0010841 120 mg | Percentage of Subjects With 50% or 75% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score | PASI-50 | 100 percentage of subjects |
| MSB0010841 240 mg | Percentage of Subjects With 50% or 75% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score | PASI-50 | 100 percentage of subjects |
| MSB0010841 240 mg | Percentage of Subjects With 50% or 75% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score | PASI-75 | 100 percentage of subjects |
| Placebo | Percentage of Subjects With 50% or 75% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score | PASI-75 | 0 percentage of subjects |
| Placebo | Percentage of Subjects With 50% or 75% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score | PASI-50 | 50 percentage of subjects |
Percentage of Subjects With Exacerbation of Psoriasis
Psoriasis exacerbation was defined as either a worsening of 25% over the baseline value of the PASI score (PASI score at any visit \>=125% of baseline PASI).
Time frame: Baseline up to Day 85
Population: Safety analysis set included all 41 subjects who received at least 1 dose of IMP (MSB0010841 or placebo).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MSB0010841 30 mg | Percentage of Subjects With Exacerbation of Psoriasis | 0 percentage of subjects |
| MSB0010841 60 mg | Percentage of Subjects With Exacerbation of Psoriasis | 0 percentage of subjects |
| MSB0010841 120 mg | Percentage of Subjects With Exacerbation of Psoriasis | 0 percentage of subjects |
| MSB0010841 240 mg | Percentage of Subjects With Exacerbation of Psoriasis | 0 percentage of subjects |
| Placebo | Percentage of Subjects With Exacerbation of Psoriasis | 12.5 percentage of subjects |
Percentage of Subjects With Static Physician's Global Assessment (sPGA) Score of Minimal or Clear and With at Least 2 Level Reduction From Baseline
The static Physician's Global Assessment (sPGA) scale rated the investigator's overall clinical assessment of a subjects plaque thickness, erythema, and scaling on a 6-point scale ranging from 0 (clear, except for residual discoloration) to 5 (majority of plaques have severe thickness, erythema, and scale). To assign a sPGA score, the investigator examined all psoriatic lesions and assigned a severity score ranging from 0 to 5 for thickness, erythema, and scaling. Scores for thickness, erythema, and scaling are summed and the mean of these 3 scores equals the overall sPGA score. Overall sPGA score ranged from 0 to 5, where lower scores indicate clinical improvement. Percentage of subjects who achieved a sPGA rating of 0 (clear) or 1 (minimal) and had at Least 2 level reduction from Baseline score were reported.
Time frame: Day 8, 15, 22, 29, 36, 43, 50, 85
Population: Safety analysis set included all 41 subjects who received at least one dose of IMP (MSB0010841 or placebo).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MSB0010841 30 mg | Percentage of Subjects With Static Physician's Global Assessment (sPGA) Score of Minimal or Clear and With at Least 2 Level Reduction From Baseline | Day 15 | 25 percentage of subjects |
| MSB0010841 30 mg | Percentage of Subjects With Static Physician's Global Assessment (sPGA) Score of Minimal or Clear and With at Least 2 Level Reduction From Baseline | Day 8 | 0 percentage of subjects |
| MSB0010841 30 mg | Percentage of Subjects With Static Physician's Global Assessment (sPGA) Score of Minimal or Clear and With at Least 2 Level Reduction From Baseline | Day 22 | 50 percentage of subjects |
| MSB0010841 30 mg | Percentage of Subjects With Static Physician's Global Assessment (sPGA) Score of Minimal or Clear and With at Least 2 Level Reduction From Baseline | Day 85 | 88 percentage of subjects |
| MSB0010841 30 mg | Percentage of Subjects With Static Physician's Global Assessment (sPGA) Score of Minimal or Clear and With at Least 2 Level Reduction From Baseline | Day 50 | 75 percentage of subjects |
| MSB0010841 30 mg | Percentage of Subjects With Static Physician's Global Assessment (sPGA) Score of Minimal or Clear and With at Least 2 Level Reduction From Baseline | Day 36 | 63 percentage of subjects |
| MSB0010841 30 mg | Percentage of Subjects With Static Physician's Global Assessment (sPGA) Score of Minimal or Clear and With at Least 2 Level Reduction From Baseline | Day 29 | 63 percentage of subjects |
| MSB0010841 30 mg | Percentage of Subjects With Static Physician's Global Assessment (sPGA) Score of Minimal or Clear and With at Least 2 Level Reduction From Baseline | Day 43 | 75 percentage of subjects |
| MSB0010841 60 mg | Percentage of Subjects With Static Physician's Global Assessment (sPGA) Score of Minimal or Clear and With at Least 2 Level Reduction From Baseline | Day 50 | 88 percentage of subjects |
| MSB0010841 60 mg | Percentage of Subjects With Static Physician's Global Assessment (sPGA) Score of Minimal or Clear and With at Least 2 Level Reduction From Baseline | Day 85 | 88 percentage of subjects |
| MSB0010841 60 mg | Percentage of Subjects With Static Physician's Global Assessment (sPGA) Score of Minimal or Clear and With at Least 2 Level Reduction From Baseline | Day 15 | 25 percentage of subjects |
| MSB0010841 60 mg | Percentage of Subjects With Static Physician's Global Assessment (sPGA) Score of Minimal or Clear and With at Least 2 Level Reduction From Baseline | Day 22 | 50 percentage of subjects |
| MSB0010841 60 mg | Percentage of Subjects With Static Physician's Global Assessment (sPGA) Score of Minimal or Clear and With at Least 2 Level Reduction From Baseline | Day 29 | 63 percentage of subjects |
| MSB0010841 60 mg | Percentage of Subjects With Static Physician's Global Assessment (sPGA) Score of Minimal or Clear and With at Least 2 Level Reduction From Baseline | Day 36 | 88 percentage of subjects |
| MSB0010841 60 mg | Percentage of Subjects With Static Physician's Global Assessment (sPGA) Score of Minimal or Clear and With at Least 2 Level Reduction From Baseline | Day 43 | 88 percentage of subjects |
| MSB0010841 60 mg | Percentage of Subjects With Static Physician's Global Assessment (sPGA) Score of Minimal or Clear and With at Least 2 Level Reduction From Baseline | Day 8 | 38 percentage of subjects |
| MSB0010841 120 mg | Percentage of Subjects With Static Physician's Global Assessment (sPGA) Score of Minimal or Clear and With at Least 2 Level Reduction From Baseline | Day 36 | 75 percentage of subjects |
| MSB0010841 120 mg | Percentage of Subjects With Static Physician's Global Assessment (sPGA) Score of Minimal or Clear and With at Least 2 Level Reduction From Baseline | Day 43 | 75 percentage of subjects |
| MSB0010841 120 mg | Percentage of Subjects With Static Physician's Global Assessment (sPGA) Score of Minimal or Clear and With at Least 2 Level Reduction From Baseline | Day 8 | 13 percentage of subjects |
| MSB0010841 120 mg | Percentage of Subjects With Static Physician's Global Assessment (sPGA) Score of Minimal or Clear and With at Least 2 Level Reduction From Baseline | Day 29 | 88 percentage of subjects |
| MSB0010841 120 mg | Percentage of Subjects With Static Physician's Global Assessment (sPGA) Score of Minimal or Clear and With at Least 2 Level Reduction From Baseline | Day 22 | 50 percentage of subjects |
| MSB0010841 120 mg | Percentage of Subjects With Static Physician's Global Assessment (sPGA) Score of Minimal or Clear and With at Least 2 Level Reduction From Baseline | Day 15 | 13 percentage of subjects |
| MSB0010841 120 mg | Percentage of Subjects With Static Physician's Global Assessment (sPGA) Score of Minimal or Clear and With at Least 2 Level Reduction From Baseline | Day 85 | 88 percentage of subjects |
| MSB0010841 120 mg | Percentage of Subjects With Static Physician's Global Assessment (sPGA) Score of Minimal or Clear and With at Least 2 Level Reduction From Baseline | Day 50 | 100 percentage of subjects |
| MSB0010841 240 mg | Percentage of Subjects With Static Physician's Global Assessment (sPGA) Score of Minimal or Clear and With at Least 2 Level Reduction From Baseline | Day 22 | 67 percentage of subjects |
| MSB0010841 240 mg | Percentage of Subjects With Static Physician's Global Assessment (sPGA) Score of Minimal or Clear and With at Least 2 Level Reduction From Baseline | Day 85 | 100 percentage of subjects |
| MSB0010841 240 mg | Percentage of Subjects With Static Physician's Global Assessment (sPGA) Score of Minimal or Clear and With at Least 2 Level Reduction From Baseline | Day 29 | 78 percentage of subjects |
| MSB0010841 240 mg | Percentage of Subjects With Static Physician's Global Assessment (sPGA) Score of Minimal or Clear and With at Least 2 Level Reduction From Baseline | Day 43 | 67 percentage of subjects |
| MSB0010841 240 mg | Percentage of Subjects With Static Physician's Global Assessment (sPGA) Score of Minimal or Clear and With at Least 2 Level Reduction From Baseline | Day 36 | 67 percentage of subjects |
| MSB0010841 240 mg | Percentage of Subjects With Static Physician's Global Assessment (sPGA) Score of Minimal or Clear and With at Least 2 Level Reduction From Baseline | Day 15 | 56 percentage of subjects |
| MSB0010841 240 mg | Percentage of Subjects With Static Physician's Global Assessment (sPGA) Score of Minimal or Clear and With at Least 2 Level Reduction From Baseline | Day 50 | 89 percentage of subjects |
| MSB0010841 240 mg | Percentage of Subjects With Static Physician's Global Assessment (sPGA) Score of Minimal or Clear and With at Least 2 Level Reduction From Baseline | Day 8 | 11 percentage of subjects |
| Placebo | Percentage of Subjects With Static Physician's Global Assessment (sPGA) Score of Minimal or Clear and With at Least 2 Level Reduction From Baseline | Day 85 | 0 percentage of subjects |
| Placebo | Percentage of Subjects With Static Physician's Global Assessment (sPGA) Score of Minimal or Clear and With at Least 2 Level Reduction From Baseline | Day 15 | 0 percentage of subjects |
| Placebo | Percentage of Subjects With Static Physician's Global Assessment (sPGA) Score of Minimal or Clear and With at Least 2 Level Reduction From Baseline | Day 22 | 0 percentage of subjects |
| Placebo | Percentage of Subjects With Static Physician's Global Assessment (sPGA) Score of Minimal or Clear and With at Least 2 Level Reduction From Baseline | Day 29 | 0 percentage of subjects |
| Placebo | Percentage of Subjects With Static Physician's Global Assessment (sPGA) Score of Minimal or Clear and With at Least 2 Level Reduction From Baseline | Day 36 | 0 percentage of subjects |
| Placebo | Percentage of Subjects With Static Physician's Global Assessment (sPGA) Score of Minimal or Clear and With at Least 2 Level Reduction From Baseline | Day 43 | 0 percentage of subjects |
| Placebo | Percentage of Subjects With Static Physician's Global Assessment (sPGA) Score of Minimal or Clear and With at Least 2 Level Reduction From Baseline | Day 50 | 0 percentage of subjects |
| Placebo | Percentage of Subjects With Static Physician's Global Assessment (sPGA) Score of Minimal or Clear and With at Least 2 Level Reduction From Baseline | Day 8 | 0 percentage of subjects |