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Multiple Ascending Dose Trial of MSB0010841 (Anti-IL17A/F Nanobody) in Psoriasis Subjects

Multicenter, Phase I, Randomized, Double-Blind, Placebo-Controlled Trial to Assess the Safety, Tolerability, Immunogenicity, Pharmacokinetics, Pharmacodynamics and Efficacy of Multiple Ascending Doses of Subcutaneous MSB0010841 (Anti-IL17A/F Nanobody) in Male and Female Subjects With Moderate to Severe Psoriasis

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02156466
Enrollment
41
Registered
2014-06-05
Start date
2014-08-31
Completion date
2015-08-31
Last updated
2017-01-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Psoriasis

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

DRUGMSB0010841

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.

DRUGPlacebo

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

Merck KGaA, Darmstadt, Germany
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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

MeasureTime frameDescription
Observed Serum Concentration Immediately Before Second Dose (Cpre) of MSB0010841Pre-dose (0 hours) on Day 15The observed serum concentration immediately before second dose.
Percentage Peak-Trough Fluctuation (PTF) Post First Dose of MSB00108410 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 MSB00108410 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 MSB00108410 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 85An 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, 43The 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, 43Subjects 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 85Data were presented for MSB0010841 combined group and placebo.
Levels of Anti-MSB0010841 Antibody TitersDay 8, 15 (pre-dose), 22, 29 (pre-dose), 36, 43, 63 and 85
Levels of Pre-existing Anti-MSB0010841 Antibody TitersPre-dose on Day 1
MSB0010841 Serum Concentration Over Time After First Dose0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336 hours post-first dose (Day 1)
MSB0010841 Serum Concentration Over Time After Second Dose0 hours (pre-dose), 24, 72, 96, 168, 336 hours post-second dose (Day 15)
MSB0010841 Serum Concentration Over Time After Third Dose0 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 MSB00108410 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 MSB00108410 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 MSB00108410 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 MSB00108410 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 MSB00108410 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 MSB0010841Pre-dose (0 hours) on Day 1The observed serum concentration immediately before the first dose.
Observed Serum Concentration Immediately Before Third Dose (Cpre) of MSB0010841Pre-dose (0 hours) on Day 29The observed serum concentration immediately before the third dose.
Minimum Concentration Observed (Cmin) During First Dosing Interval of MSB00108410 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 MSB00108410 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 MSB00108410 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 MSB00108410 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 MSB00108410 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 MSB00108410 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 MSB00108410 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 MSB00108410 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 MSB00108410 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 MSB00108410 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 MSB00108410 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 MSB00108410 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 MSB00108410 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 MSB00108410 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 MSB00108410 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 MSB00108410 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

MeasureTime frameDescription
Mean Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Day 43Baseline, Day 43PASI: 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 BaselineDay 8, 15, 22, 29, 36, 43, 50, 85The 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 85Baseline, Day 8, 15, 22, 29, 36, 43, 50 and 85The 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 PsoriasisBaseline up to Day 85Psoriasis 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) ScoreBaseline up to Day 85PASI: 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

ArmCount
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
Total41

Withdrawals & dropouts

PeriodReasonFG000FG001FG002FG003FG004
Overall StudyAdverse Event00110
Overall StudyQuantiferon Positivity00010

Baseline characteristics

CharacteristicMSB0010841 30 mgMSB0010841 240 mgMSB0010841 60 mgMSB0010841 120 mgPlaceboTotal
Age, Continuous48.6 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 Participants1 Participants0 Participants2 Participants2 Participants6 Participants
Gender
Male
7 Participants8 Participants8 Participants6 Participants6 Participants35 Participants

Adverse events

Event typeEG000
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 / 85 / 85 / 86 / 96 / 8
serious
Total, serious adverse events
1 / 80 / 80 / 80 / 90 / 8

Outcome results

Primary

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.

ArmMeasureValue (GEOMETRIC_MEAN)Dispersion
MSB0010841 30 mgAccumulation Ratio of AUC (Racc(AUC))1.61 ratioGeometric Coefficient of Variation 15.9
MSB0010841 60 mgAccumulation Ratio of AUC (Racc(AUC))1.50 ratioGeometric Coefficient of Variation 18.4
MSB0010841 120 mgAccumulation Ratio of AUC (Racc(AUC))1.61 ratioGeometric Coefficient of Variation 27.4
MSB0010841 240 mgAccumulation Ratio of AUC (Racc(AUC))1.83 ratioGeometric Coefficient of Variation 11.5
Primary

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.

ArmMeasureValue (GEOMETRIC_MEAN)Dispersion
MSB0010841 30 mgAccumulation Ratio of Cmax (Racc (Cmax))1.56 ratioGeometric Coefficient of Variation 17.9
MSB0010841 60 mgAccumulation Ratio of Cmax (Racc (Cmax))1.52 ratioGeometric Coefficient of Variation 23.5
MSB0010841 120 mgAccumulation Ratio of Cmax (Racc (Cmax))1.56 ratioGeometric Coefficient of Variation 34.1
MSB0010841 240 mgAccumulation Ratio of Cmax (Racc (Cmax))1.81 ratioGeometric Coefficient of Variation 9.5
Primary

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.

ArmMeasureGroupValue (NUMBER)
MSB0010841 30 mgAmount of Pain at Injection Site Assessed By Visual Analog Scale (VAS)Day 43 (n=0,0,0,0,0)NA mm
MSB0010841 30 mgAmount of Pain at Injection Site Assessed By Visual Analog Scale (VAS)Day 1 (n=3,2,3,2,0)7 mm
MSB0010841 30 mgAmount of Pain at Injection Site Assessed By Visual Analog Scale (VAS)Day 15 (n=2,1,3,0,0)5 mm
MSB0010841 30 mgAmount of Pain at Injection Site Assessed By Visual Analog Scale (VAS)Day 16 (n=0,0,0,0,2)NA mm
MSB0010841 30 mgAmount of Pain at Injection Site Assessed By Visual Analog Scale (VAS)Day 22 (1,0,1,0,0)11 mm
MSB0010841 30 mgAmount of Pain at Injection Site Assessed By Visual Analog Scale (VAS)Day 8 (n=1,1,0,0,0)1 mm
MSB0010841 30 mgAmount of Pain at Injection Site Assessed By Visual Analog Scale (VAS)Day 29 (n=1,1,1,0,0)3 mm
MSB0010841 30 mgAmount of Pain at Injection Site Assessed By Visual Analog Scale (VAS)Day 36 (n=0,0,0,0,0)NA mm
MSB0010841 30 mgAmount of Pain at Injection Site Assessed By Visual Analog Scale (VAS)Day 30 (1,0,1,1,0)2 mm
MSB0010841 30 mgAmount of Pain at Injection Site Assessed By Visual Analog Scale (VAS)Day 2 (n=1,1,1,1,0)1 mm
MSB0010841 60 mgAmount of Pain at Injection Site Assessed By Visual Analog Scale (VAS)Day 2 (n=1,1,1,1,0)1 mm
MSB0010841 60 mgAmount of Pain at Injection Site Assessed By Visual Analog Scale (VAS)Day 43 (n=0,0,0,0,0)NA mm
MSB0010841 60 mgAmount of Pain at Injection Site Assessed By Visual Analog Scale (VAS)Day 29 (n=1,1,1,0,0)2 mm
MSB0010841 60 mgAmount of Pain at Injection Site Assessed By Visual Analog Scale (VAS)Day 8 (n=1,1,0,0,0)1 mm
MSB0010841 60 mgAmount of Pain at Injection Site Assessed By Visual Analog Scale (VAS)Day 1 (n=3,2,3,2,0)4 mm
MSB0010841 60 mgAmount of Pain at Injection Site Assessed By Visual Analog Scale (VAS)Day 15 (n=2,1,3,0,0)3 mm
MSB0010841 60 mgAmount of Pain at Injection Site Assessed By Visual Analog Scale (VAS)Day 22 (1,0,1,0,0)NA mm
MSB0010841 60 mgAmount of Pain at Injection Site Assessed By Visual Analog Scale (VAS)Day 36 (n=0,0,0,0,0)NA mm
MSB0010841 60 mgAmount of Pain at Injection Site Assessed By Visual Analog Scale (VAS)Day 16 (n=0,0,0,0,2)NA mm
MSB0010841 60 mgAmount of Pain at Injection Site Assessed By Visual Analog Scale (VAS)Day 30 (1,0,1,1,0)NA mm
MSB0010841 120 mgAmount of Pain at Injection Site Assessed By Visual Analog Scale (VAS)Day 30 (1,0,1,1,0)1 mm
MSB0010841 120 mgAmount of Pain at Injection Site Assessed By Visual Analog Scale (VAS)Day 16 (n=0,0,0,0,2)NA mm
MSB0010841 120 mgAmount of Pain at Injection Site Assessed By Visual Analog Scale (VAS)Day 36 (n=0,0,0,0,0)NA mm
MSB0010841 120 mgAmount of Pain at Injection Site Assessed By Visual Analog Scale (VAS)Day 43 (n=0,0,0,0,0)NA mm
MSB0010841 120 mgAmount of Pain at Injection Site Assessed By Visual Analog Scale (VAS)Day 2 (n=1,1,1,1,0)1 mm
MSB0010841 120 mgAmount of Pain at Injection Site Assessed By Visual Analog Scale (VAS)Day 1 (n=3,2,3,2,0)7 mm
MSB0010841 120 mgAmount of Pain at Injection Site Assessed By Visual Analog Scale (VAS)Day 8 (n=1,1,0,0,0)NA mm
MSB0010841 120 mgAmount of Pain at Injection Site Assessed By Visual Analog Scale (VAS)Day 15 (n=2,1,3,0,0)7 mm
MSB0010841 120 mgAmount of Pain at Injection Site Assessed By Visual Analog Scale (VAS)Day 22 (1,0,1,0,0)1 mm
MSB0010841 120 mgAmount of Pain at Injection Site Assessed By Visual Analog Scale (VAS)Day 29 (n=1,1,1,0,0)2 mm
MSB0010841 240 mgAmount of Pain at Injection Site Assessed By Visual Analog Scale (VAS)Day 1 (n=3,2,3,2,0)4 mm
MSB0010841 240 mgAmount of Pain at Injection Site Assessed By Visual Analog Scale (VAS)Day 30 (1,0,1,1,0)1 mm
MSB0010841 240 mgAmount of Pain at Injection Site Assessed By Visual Analog Scale (VAS)Day 2 (n=1,1,1,1,0)1 mm
MSB0010841 240 mgAmount of Pain at Injection Site Assessed By Visual Analog Scale (VAS)Day 8 (n=1,1,0,0,0)NA mm
MSB0010841 240 mgAmount of Pain at Injection Site Assessed By Visual Analog Scale (VAS)Day 15 (n=2,1,3,0,0)NA mm
MSB0010841 240 mgAmount of Pain at Injection Site Assessed By Visual Analog Scale (VAS)Day 16 (n=0,0,0,0,2)NA mm
MSB0010841 240 mgAmount of Pain at Injection Site Assessed By Visual Analog Scale (VAS)Day 22 (1,0,1,0,0)NA mm
MSB0010841 240 mgAmount of Pain at Injection Site Assessed By Visual Analog Scale (VAS)Day 43 (n=0,0,0,0,0)NA mm
MSB0010841 240 mgAmount of Pain at Injection Site Assessed By Visual Analog Scale (VAS)Day 29 (n=1,1,1,0,0)NA mm
MSB0010841 240 mgAmount of Pain at Injection Site Assessed By Visual Analog Scale (VAS)Day 36 (n=0,0,0,0,0)NA mm
PlaceboAmount of Pain at Injection Site Assessed By Visual Analog Scale (VAS)Day 36 (n=0,0,0,0,0)NA mm
PlaceboAmount of Pain at Injection Site Assessed By Visual Analog Scale (VAS)Day 15 (n=2,1,3,0,0)NA mm
PlaceboAmount of Pain at Injection Site Assessed By Visual Analog Scale (VAS)Day 2 (n=1,1,1,1,0)NA mm
PlaceboAmount of Pain at Injection Site Assessed By Visual Analog Scale (VAS)Day 30 (1,0,1,1,0)NA mm
PlaceboAmount of Pain at Injection Site Assessed By Visual Analog Scale (VAS)Day 22 (1,0,1,0,0)NA mm
PlaceboAmount of Pain at Injection Site Assessed By Visual Analog Scale (VAS)Day 29 (n=1,1,1,0,0)NA mm
PlaceboAmount of Pain at Injection Site Assessed By Visual Analog Scale (VAS)Day 8 (n=1,1,0,0,0)NA mm
PlaceboAmount of Pain at Injection Site Assessed By Visual Analog Scale (VAS)Day 43 (n=0,0,0,0,0)NA mm
PlaceboAmount of Pain at Injection Site Assessed By Visual Analog Scale (VAS)Day 1 (n=3,2,3,2,0)NA mm
PlaceboAmount of Pain at Injection Site Assessed By Visual Analog Scale (VAS)Day 16 (n=0,0,0,0,2)2 mm
Primary

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.

ArmMeasureValue (GEOMETRIC_MEAN)Dispersion
MSB0010841 30 mgApparent Clearance (CL/f) Post Third Dose of MSB00108410.55 L/dayGeometric Coefficient of Variation 36.3
MSB0010841 60 mgApparent Clearance (CL/f) Post Third Dose of MSB00108410.58 L/dayGeometric Coefficient of Variation 33.9
MSB0010841 120 mgApparent Clearance (CL/f) Post Third Dose of MSB00108410.59 L/dayGeometric Coefficient of Variation 43.6
MSB0010841 240 mgApparent Clearance (CL/f) Post Third Dose of MSB00108410.60 L/dayGeometric Coefficient of Variation 27.1
Primary

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.

ArmMeasureValue (GEOMETRIC_MEAN)Dispersion
MSB0010841 30 mgApparent Terminal Half-life (t1/2) Post Third Dose of MSB001084110.63 dayGeometric Coefficient of Variation 17.3
MSB0010841 60 mgApparent Terminal Half-life (t1/2) Post Third Dose of MSB001084110.50 dayGeometric Coefficient of Variation 18.9
MSB0010841 120 mgApparent Terminal Half-life (t1/2) Post Third Dose of MSB001084112.19 dayGeometric Coefficient of Variation 27.9
MSB0010841 240 mgApparent Terminal Half-life (t1/2) Post Third Dose of MSB001084110.25 dayGeometric Coefficient of Variation 13.1
Primary

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.

ArmMeasureValue (GEOMETRIC_MEAN)Dispersion
MSB0010841 30 mgApparent Volume of Distribution During Terminal Phase (Vz/f) Post Third Dose of MSB00108418.49 LitersGeometric Coefficient of Variation 27
MSB0010841 60 mgApparent Volume of Distribution During Terminal Phase (Vz/f) Post Third Dose of MSB00108418.73 LitersGeometric Coefficient of Variation 38.6
MSB0010841 120 mgApparent Volume of Distribution During Terminal Phase (Vz/f) Post Third Dose of MSB001084110.39 LitersGeometric Coefficient of Variation 21.9
MSB0010841 240 mgApparent Volume of Distribution During Terminal Phase (Vz/f) Post Third Dose of MSB00108418.92 LitersGeometric Coefficient of Variation 18.8
Primary

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.

ArmMeasureValue (GEOMETRIC_MEAN)Dispersion
MSB0010841 30 mgArea Under the Concentration-time Curve From Time Zero to Infinity (AUC 0-inf) Post Third Dose of MSB001084197.6 day*ug/mLGeometric Coefficient of Variation 42.2
MSB0010841 60 mgArea Under the Concentration-time Curve From Time Zero to Infinity (AUC 0-inf) Post Third Dose of MSB0010841174.9 day*ug/mLGeometric Coefficient of Variation 39.9
MSB0010841 120 mgArea Under the Concentration-time Curve From Time Zero to Infinity (AUC 0-inf) Post Third Dose of MSB0010841392.6 day*ug/mLGeometric Coefficient of Variation 68.8
MSB0010841 240 mgArea Under the Concentration-time Curve From Time Zero to Infinity (AUC 0-inf) Post Third Dose of MSB0010841680.9 day*ug/mLGeometric Coefficient of Variation 32.2
Primary

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.

ArmMeasureValue (GEOMETRIC_MEAN)Dispersion
MSB0010841 30 mgArea Under the Concentration-Time Curve From Time Zero up to Time Tau (AUCtau) Post First Dose of MSB001084132.4 day*mcg/mLGeometric Coefficient of Variation 31.2
MSB0010841 60 mgArea Under the Concentration-Time Curve From Time Zero up to Time Tau (AUCtau) Post First Dose of MSB001084168.3 day*mcg/mLGeometric Coefficient of Variation 16.4
MSB0010841 120 mgArea Under the Concentration-Time Curve From Time Zero up to Time Tau (AUCtau) Post First Dose of MSB0010841114.6 day*mcg/mLGeometric Coefficient of Variation 24.2
MSB0010841 240 mgArea Under the Concentration-Time Curve From Time Zero up to Time Tau (AUCtau) Post First Dose of MSB0010841222.2 day*mcg/mLGeometric Coefficient of Variation 19.6
Primary

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.

ArmMeasureValue (GEOMETRIC_MEAN)Dispersion
MSB0010841 30 mgArea Under the Concentration-Time Curve From Time Zero up to Time Tau (AUCtau) Post Third Dose of MSB001084154.2 day*mcg/mLGeometric Coefficient of Variation 36.3
MSB0010841 60 mgArea Under the Concentration-Time Curve From Time Zero up to Time Tau (AUCtau) Post Third Dose of MSB0010841104.1 day*mcg/mLGeometric Coefficient of Variation 33.9
MSB0010841 120 mgArea Under the Concentration-Time Curve From Time Zero up to Time Tau (AUCtau) Post Third Dose of MSB0010841203.2 day*mcg/mLGeometric Coefficient of Variation 43.6
MSB0010841 240 mgArea Under the Concentration-Time Curve From Time Zero up to Time Tau (AUCtau) Post Third Dose of MSB0010841397.6 day*mcg/mLGeometric Coefficient of Variation 27.1
Primary

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.

ArmMeasureValue (GEOMETRIC_MEAN)Dispersion
MSB0010841 30 mgArea Under the Curve From Time Zero to Last Quantifiable Concentration (AUC0-t) Post First Dose of MSB001084133.6 day*microgram per milliliter (day*mcg/mLGeometric Coefficient of Variation 28
MSB0010841 60 mgArea Under the Curve From Time Zero to Last Quantifiable Concentration (AUC0-t) Post First Dose of MSB001084169.3 day*microgram per milliliter (day*mcg/mLGeometric Coefficient of Variation 18.9
MSB0010841 120 mgArea Under the Curve From Time Zero to Last Quantifiable Concentration (AUC0-t) Post First Dose of MSB0010841126.3 day*microgram per milliliter (day*mcg/mLGeometric Coefficient of Variation 28.5
MSB0010841 240 mgArea Under the Curve From Time Zero to Last Quantifiable Concentration (AUC0-t) Post First Dose of MSB0010841216.5 day*microgram per milliliter (day*mcg/mLGeometric Coefficient of Variation 23.4
Primary

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.

ArmMeasureValue (GEOMETRIC_MEAN)Dispersion
MSB0010841 30 mgArea Under the Curve From Time Zero to Last Quantifiable Concentration (AUC0-t) Post Third Dose of MSB001084193.7 day*mcg/mLGeometric Coefficient of Variation 41.4
MSB0010841 60 mgArea Under the Curve From Time Zero to Last Quantifiable Concentration (AUC0-t) Post Third Dose of MSB0010841170.3 day*mcg/mLGeometric Coefficient of Variation 39.5
MSB0010841 120 mgArea Under the Curve From Time Zero to Last Quantifiable Concentration (AUC0-t) Post Third Dose of MSB0010841371.7 day*mcg/mLGeometric Coefficient of Variation 62
MSB0010841 240 mgArea Under the Curve From Time Zero to Last Quantifiable Concentration (AUC0-t) Post Third Dose of MSB0010841663.4 day*mcg/mLGeometric Coefficient of Variation 31.1
Primary

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.

ArmMeasureValue (GEOMETRIC_MEAN)Dispersion
MSB0010841 30 mgAverage Concentration (Cav) Post First Dose of MSB00108412.315 mcg/mLGeometric Coefficient of Variation 31.2
MSB0010841 60 mgAverage Concentration (Cav) Post First Dose of MSB00108414.881 mcg/mLGeometric Coefficient of Variation 16.4
MSB0010841 120 mgAverage Concentration (Cav) Post First Dose of MSB00108418.187 mcg/mLGeometric Coefficient of Variation 24.2
MSB0010841 240 mgAverage Concentration (Cav) Post First Dose of MSB001084115.868 mcg/mLGeometric Coefficient of Variation 19.6
Primary

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.

ArmMeasureValue (GEOMETRIC_MEAN)Dispersion
MSB0010841 30 mgAverage Concentration (Cav) Post Third Dose of MSB00108413.87 mcg/mLGeometric Coefficient of Variation 36.3
MSB0010841 60 mgAverage Concentration (Cav) Post Third Dose of MSB00108417.44 mcg/mLGeometric Coefficient of Variation 33.9
MSB0010841 120 mgAverage Concentration (Cav) Post Third Dose of MSB001084114.51 mcg/mLGeometric Coefficient of Variation 43.6
MSB0010841 240 mgAverage Concentration (Cav) Post Third Dose of MSB001084128.40 mcg/mLGeometric Coefficient of Variation 27.1
Primary

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.

ArmMeasureGroupValue (NUMBER)
MSB0010841 30 mgLevels of Anti-MSB0010841 Antibody TitersDay 36 Subject 11: MSB0010841 120 mg4.38 log10titer
MSB0010841 30 mgLevels of Anti-MSB0010841 Antibody TitersDay 36 Subject 12: MSB0010841 120 mg3.68 log10titer
MSB0010841 30 mgLevels of Anti-MSB0010841 Antibody TitersDay 36 Subject 13: MSB0010841 240 mg2.98 log10titer
MSB0010841 30 mgLevels of Anti-MSB0010841 Antibody TitersDay 43 Subject 1: Placebo2.98 log10titer
MSB0010841 30 mgLevels of Anti-MSB0010841 Antibody TitersDay 43 Subject 2: Placebo3.68 log10titer
MSB0010841 30 mgLevels of Anti-MSB0010841 Antibody TitersDay 43 Subject 8: MSB0010841 120 mg4.38 log10titer
MSB0010841 30 mgLevels of Anti-MSB0010841 Antibody TitersDay 43 Subject 9: MSB0010841 120 mg3.68 log10titer
MSB0010841 30 mgLevels of Anti-MSB0010841 Antibody TitersDay 43 Subject 10: MSB0010841 120 mg4.38 log10titer
MSB0010841 30 mgLevels of Anti-MSB0010841 Antibody TitersDay 43 Subject 11: MSB0010841 120 mg3.68 log10titer
MSB0010841 30 mgLevels of Anti-MSB0010841 Antibody TitersDay 8 Subject 1: Placebo3.68 log10titer
MSB0010841 30 mgLevels of Anti-MSB0010841 Antibody TitersDay 8 Subject 2: Placebo3.68 log10titer
MSB0010841 30 mgLevels of Anti-MSB0010841 Antibody TitersDay 8 Subject 3: Placebo3.68 log10titer
MSB0010841 30 mgLevels of Anti-MSB0010841 Antibody TitersDay 8 Subject 4: MSB0010841 30 mg3.68 log10titer
MSB0010841 30 mgLevels of Anti-MSB0010841 Antibody TitersDay 8 Subject 5: MSB0010841 30 mg0 log10titer
MSB0010841 30 mgLevels of Anti-MSB0010841 Antibody TitersDay 8 Subject 6: MSB0010841 30 mg2.28 log10titer
MSB0010841 30 mgLevels of Anti-MSB0010841 Antibody TitersDay 8 Subject 7: MSB0010841 60 mg0 log10titer
MSB0010841 30 mgLevels of Anti-MSB0010841 Antibody TitersDay 8 Subject 8: MSB0010841 120 mg3.68 log10titer
MSB0010841 30 mgLevels of Anti-MSB0010841 Antibody TitersDay 8 Subject 9: MSB0010841 120 mg4.38 log10titer
MSB0010841 30 mgLevels of Anti-MSB0010841 Antibody TitersDay 8 Subject 10: MSB0010841 120 mg3.68 log10titer
MSB0010841 30 mgLevels of Anti-MSB0010841 Antibody TitersDay 8 Subject 11: MSB0010841 120 mg4.38 log10titer
MSB0010841 30 mgLevels of Anti-MSB0010841 Antibody TitersDay 8 Subject 12: MSB0010841 120 mg2.98 log10titer
MSB0010841 30 mgLevels of Anti-MSB0010841 Antibody TitersDay 8 Subject 13: MSB0010841 240 mg2.98 log10titer
MSB0010841 30 mgLevels of Anti-MSB0010841 Antibody TitersDay 15 (pre-dose) Subject 1: Placebo3.68 log10titer
MSB0010841 30 mgLevels of Anti-MSB0010841 Antibody TitersDay 15 (pre-dose) Subject 2: Placebo3.68 log10titer
MSB0010841 30 mgLevels of Anti-MSB0010841 Antibody TitersDay 15 (pre-dose) Subject 3: Placebo3.68 log10titer
MSB0010841 30 mgLevels of Anti-MSB0010841 Antibody TitersDay 15 (pre-dose) Subject 4: MSB0010841 30 mg3.68 log10titer
MSB0010841 30 mgLevels of Anti-MSB0010841 Antibody TitersDay 15 (pre-dose) Subject 5: MSB0010841 30 mg0 log10titer
MSB0010841 30 mgLevels of Anti-MSB0010841 Antibody TitersDay 15 (pre-dose) Subject 6: MSB0010841 30 mg2.28 log10titer
MSB0010841 30 mgLevels of Anti-MSB0010841 Antibody TitersDay 15 (pre-dose) Subject 7: MSB0010841 60 mg2.98 log10titer
MSB0010841 30 mgLevels of Anti-MSB0010841 Antibody TitersDay 15 (pre-dose) Subject 8: MSB0010841 120 mg5.78 log10titer
MSB0010841 30 mgLevels of Anti-MSB0010841 Antibody TitersDay 15 (pre-dose) Subject 9: MSB0010841 120 mg4.38 log10titer
MSB0010841 30 mgLevels of Anti-MSB0010841 Antibody TitersDay 15 (pre-dose) Subject 10: MSB0010841 120 mg3.68 log10titer
MSB0010841 30 mgLevels of Anti-MSB0010841 Antibody TitersDay 15 (pre-dose) Subject 11: MSB0010841 120 mg4.38 log10titer
MSB0010841 30 mgLevels of Anti-MSB0010841 Antibody TitersDay 15 (pre-dose) Subject 12: MSB0010841 120 mg2.98 log10titer
MSB0010841 30 mgLevels of Anti-MSB0010841 Antibody TitersDay 15 (pre-dose) Subject 13: MSB0010841 240 mg2.98 log10titer
MSB0010841 30 mgLevels of Anti-MSB0010841 Antibody TitersDay 22 Subject 1: Placebo3.68 log10titer
MSB0010841 30 mgLevels of Anti-MSB0010841 Antibody TitersDay 22 Subject 2: Placebo3.68 log10titer
MSB0010841 30 mgLevels of Anti-MSB0010841 Antibody TitersDay 22 Subject 3: Placebo3.68 log10titer
MSB0010841 30 mgLevels of Anti-MSB0010841 Antibody TitersDay 22 Subject 4: MSB0010841 30 mg3.68 log10titer
MSB0010841 30 mgLevels of Anti-MSB0010841 Antibody TitersDay 22 Subject 5: MSB0010841 30 mg2.98 log10titer
MSB0010841 30 mgLevels of Anti-MSB0010841 Antibody TitersDay 22 Subject 6: MSB0010841 30 mg2.98 log10titer
MSB0010841 30 mgLevels of Anti-MSB0010841 Antibody TitersDay 22 Subject 7: MSB0010841 60 mg2.28 log10titer
MSB0010841 30 mgLevels of Anti-MSB0010841 Antibody TitersDay 22 Subject 8: MSB0010841 120 mg2.98 log10titer
MSB0010841 30 mgLevels of Anti-MSB0010841 Antibody TitersDay 22 Subject 9: MSB0010841 120 mg4.38 log10titer
MSB0010841 30 mgLevels of Anti-MSB0010841 Antibody TitersDay 22 Subject 10: MSB0010841 120 mg3.68 log10titer
MSB0010841 30 mgLevels of Anti-MSB0010841 Antibody TitersDay 22 Subject 11: MSB0010841 120 mg4.38 log10titer
MSB0010841 30 mgLevels of Anti-MSB0010841 Antibody TitersDay 22 Subject 12: MSB0010841 120 mg2.98 log10titer
MSB0010841 30 mgLevels of Anti-MSB0010841 Antibody TitersDay 22 Subject 13: MSB0010841 240 mg2.98 log10titer
MSB0010841 30 mgLevels of Anti-MSB0010841 Antibody TitersDay 29 (pre-dose) Subject 1: Placebo3.68 log10titer
MSB0010841 30 mgLevels of Anti-MSB0010841 Antibody TitersDay 29 (pre-dose) Subject 2: Placebo3.68 log10titer
MSB0010841 30 mgLevels of Anti-MSB0010841 Antibody TitersDay 29 (pre-dose) Subject 3: Placebo3.68 log10titer
MSB0010841 30 mgLevels of Anti-MSB0010841 Antibody TitersDay 29 (pre-dose) Subject 4: MSB0010841 30 mg2.98 log10titer
MSB0010841 30 mgLevels of Anti-MSB0010841 Antibody TitersDay 29 (pre-dose) Subject 5: MSB0010841 30 mg0 log10titer
MSB0010841 30 mgLevels of Anti-MSB0010841 Antibody TitersDay 29 (pre-dose) Subject 6: MSB0010841 30 mg2.98 log10titer
MSB0010841 30 mgLevels of Anti-MSB0010841 Antibody TitersDay 29 (pre-dose) Subject 7: MSB0010841 60 mg2.28 log10titer
MSB0010841 30 mgLevels of Anti-MSB0010841 Antibody TitersDay 29 (pre-dose) Subject 8: MSB0010841 120 mg3.68 log10titer
MSB0010841 30 mgLevels of Anti-MSB0010841 Antibody TitersDay 29 (pre-dose) Subject 9: MSB0010841 120 mg3.68 log10titer
MSB0010841 30 mgLevels of Anti-MSB0010841 Antibody TitersDay 29 (pre-dose) Subject 10: MSB0010841 120 mg3.68 log10titer
MSB0010841 30 mgLevels of Anti-MSB0010841 Antibody TitersDay 29 (pre-dose) Subject 11: MSB0010841 120 mg4.38 log10titer
MSB0010841 30 mgLevels of Anti-MSB0010841 Antibody TitersDay 29 (pre-dose) Subject 12: MSB0010841 120 mg2.98 log10titer
MSB0010841 30 mgLevels of Anti-MSB0010841 Antibody TitersDay 29 (pre-dose) Subject 13: MSB0010841 240 mg2.98 log10titer
MSB0010841 30 mgLevels of Anti-MSB0010841 Antibody TitersDay 36 Subject 1: PlaceboNA log10titer
MSB0010841 30 mgLevels of Anti-MSB0010841 Antibody TitersDay 36 Subject 2: Placebo3.68 log10titer
MSB0010841 30 mgLevels of Anti-MSB0010841 Antibody TitersDay 36 Subject 3: Placebo3.68 log10titer
MSB0010841 30 mgLevels of Anti-MSB0010841 Antibody TitersDay 36 Subject 4: MSB0010841 30 mg2.98 log10titer
MSB0010841 30 mgLevels of Anti-MSB0010841 Antibody TitersDay 36 Subject 5: MSB0010841 30 mg0 log10titer
MSB0010841 30 mgLevels of Anti-MSB0010841 Antibody TitersDay 36 Subject 6: MSB0010841 30 mg2.98 log10titer
MSB0010841 30 mgLevels of Anti-MSB0010841 Antibody TitersDay 36 Subject 7: MSB0010841 60 mg2.98 log10titer
MSB0010841 30 mgLevels of Anti-MSB0010841 Antibody TitersDay 36 Subject 8: MSB0010841 120 mgNA log10titer
MSB0010841 30 mgLevels of Anti-MSB0010841 Antibody TitersDay 36 Subject 9: MSB0010841 120 mg3.68 log10titer
MSB0010841 30 mgLevels of Anti-MSB0010841 Antibody TitersDay 36 Subject 10: MSB0010841 120 mg4.38 log10titer
MSB0010841 30 mgLevels of Anti-MSB0010841 Antibody TitersDay 43 Subject 3: Placebo3.68 log10titer
MSB0010841 30 mgLevels of Anti-MSB0010841 Antibody TitersDay 43 Subject 4: MSB0010841 30 mg2.98 log10titer
MSB0010841 30 mgLevels of Anti-MSB0010841 Antibody TitersDay 43 Subject 5: MSB0010841 30 mg0 log10titer
MSB0010841 30 mgLevels of Anti-MSB0010841 Antibody TitersDay 43 Subject 6: MSB0010841 30 mg2.98 log10titer
MSB0010841 30 mgLevels of Anti-MSB0010841 Antibody TitersDay 43 Subject 7: MSB0010841 60 mg2.28 log10titer
MSB0010841 30 mgLevels of Anti-MSB0010841 Antibody TitersDay 43 Subject 12: MSB0010841 120 mg2.98 log10titer
MSB0010841 30 mgLevels of Anti-MSB0010841 Antibody TitersDay 43 Subject 13: MSB0010841 240 mg2.98 log10titer
MSB0010841 30 mgLevels of Anti-MSB0010841 Antibody TitersDay 63 Subject 1: Placebo3.68 log10titer
MSB0010841 30 mgLevels of Anti-MSB0010841 Antibody TitersDay 63 Subject 2: Placebo3.68 log10titer
MSB0010841 30 mgLevels of Anti-MSB0010841 Antibody TitersDay 63 Subject 3: Placebo3.68 log10titer
MSB0010841 30 mgLevels of Anti-MSB0010841 Antibody TitersDay 63 Subject 4: MSB0010841 30 mg4.38 log10titer
MSB0010841 30 mgLevels of Anti-MSB0010841 Antibody TitersDay 63 Subject 5: MSB0010841 30 mg0 log10titer
MSB0010841 30 mgLevels of Anti-MSB0010841 Antibody TitersDay 63 Subject 6: MSB0010841 30 mg2.98 log10titer
MSB0010841 30 mgLevels of Anti-MSB0010841 Antibody TitersDay 63 Subject 7: MSB0010841 60 mg2.28 log10titer
MSB0010841 30 mgLevels of Anti-MSB0010841 Antibody TitersDay 63 Subject 8: MSB0010841 120 mg2.98 log10titer
MSB0010841 30 mgLevels of Anti-MSB0010841 Antibody TitersDay 63 Subject 9: MSB0010841 120 mg3.68 log10titer
MSB0010841 30 mgLevels of Anti-MSB0010841 Antibody TitersDay 63 Subject 10: MSB0010841 120 mg3.68 log10titer
MSB0010841 30 mgLevels of Anti-MSB0010841 Antibody TitersDay 63 Subject 11: MSB0010841 120 mg3.68 log10titer
MSB0010841 30 mgLevels of Anti-MSB0010841 Antibody TitersDay 63 Subject 12: MSB0010841 120 mg3.68 log10titer
MSB0010841 30 mgLevels of Anti-MSB0010841 Antibody TitersDay 63 Subject 13: MSB0010841 240 mg2.98 log10titer
MSB0010841 30 mgLevels of Anti-MSB0010841 Antibody TitersDay 85 Subject 1: Placebo3.68 log10titer
MSB0010841 30 mgLevels of Anti-MSB0010841 Antibody TitersDay 85 Subject 2: Placebo3.68 log10titer
MSB0010841 30 mgLevels of Anti-MSB0010841 Antibody TitersDay 85 Subject 3: Placebo3.68 log10titer
MSB0010841 30 mgLevels of Anti-MSB0010841 Antibody TitersDay 85 Subject 4: MSB0010841 30 mg3.68 log10titer
MSB0010841 30 mgLevels of Anti-MSB0010841 Antibody TitersDay 85 Subject 5: MSB0010841 30 mg0 log10titer
MSB0010841 30 mgLevels of Anti-MSB0010841 Antibody TitersDay 85 Subject 6: MSB0010841 30 mg2.28 log10titer
MSB0010841 30 mgLevels of Anti-MSB0010841 Antibody TitersDay 85 Subject 7: MSB0010841 60 mg2.28 log10titer
MSB0010841 30 mgLevels of Anti-MSB0010841 Antibody TitersDay 85 Subject 8: MSB0010841 120 mg2.98 log10titer
MSB0010841 30 mgLevels of Anti-MSB0010841 Antibody TitersDay 85 Subject 9: MSB0010841 120 mg3.68 log10titer
MSB0010841 30 mgLevels of Anti-MSB0010841 Antibody TitersDay 85 Subject 10: MSB0010841 120 mg3.68 log10titer
MSB0010841 30 mgLevels of Anti-MSB0010841 Antibody TitersDay 85 Subject 11: MSB0010841 120 mg2.98 log10titer
MSB0010841 30 mgLevels of Anti-MSB0010841 Antibody TitersDay 85 Subject 12: MSB0010841 120 mg3.68 log10titer
MSB0010841 30 mgLevels of Anti-MSB0010841 Antibody TitersDay 85 Subject 13: MSB0010841 240 mg2.98 log10titer
Primary

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.

ArmMeasureGroupValue (NUMBER)
MSB0010841 30 mgLevels of Pre-existing Anti-MSB0010841 Antibody TitersSubject 1: Placebo2.98 log10titer
MSB0010841 30 mgLevels of Pre-existing Anti-MSB0010841 Antibody TitersSubject 2: Placebo3.68 log10titer
MSB0010841 30 mgLevels of Pre-existing Anti-MSB0010841 Antibody TitersSubject 3: Placebo3.68 log10titer
MSB0010841 30 mgLevels of Pre-existing Anti-MSB0010841 Antibody TitersSubject 4: MSB0010841 30 mg2.98 log10titer
MSB0010841 30 mgLevels of Pre-existing Anti-MSB0010841 Antibody TitersSubject 5: MSB0010841 30 mg0 log10titer
MSB0010841 30 mgLevels of Pre-existing Anti-MSB0010841 Antibody TitersSubject 6: MSB0010841 30 mg0 log10titer
MSB0010841 30 mgLevels of Pre-existing Anti-MSB0010841 Antibody TitersSubject 7: MSB0010841 60 mg0 log10titer
MSB0010841 30 mgLevels of Pre-existing Anti-MSB0010841 Antibody TitersSubject 8: MSB0010841 120 mg2.98 log10titer
MSB0010841 30 mgLevels of Pre-existing Anti-MSB0010841 Antibody TitersSubject 9: MSB0010841 120 mg5.08 log10titer
MSB0010841 30 mgLevels of Pre-existing Anti-MSB0010841 Antibody TitersSubject 10: MSB0010841 120 mg3.68 log10titer
MSB0010841 30 mgLevels of Pre-existing Anti-MSB0010841 Antibody TitersSubject 11: MSB0010841 120 mg3.68 log10titer
MSB0010841 30 mgLevels of Pre-existing Anti-MSB0010841 Antibody TitersSubject 12: MSB0010841 120 mg2.98 log10titer
MSB0010841 30 mgLevels of Pre-existing Anti-MSB0010841 Antibody TitersSubject 13: MSB0010841 240 mg0 log10titer
Primary

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.

ArmMeasureValue (GEOMETRIC_MEAN)Dispersion
MSB0010841 30 mgMaximum Concentration Observed (Cmax) Post First Dose of MSB00108413.3 mcg/mLGeometric Coefficient of Variation 28.4
MSB0010841 60 mgMaximum Concentration Observed (Cmax) Post First Dose of MSB00108417.4 mcg/mLGeometric Coefficient of Variation 22.9
MSB0010841 120 mgMaximum Concentration Observed (Cmax) Post First Dose of MSB001084112.5 mcg/mLGeometric Coefficient of Variation 25.6
MSB0010841 240 mgMaximum Concentration Observed (Cmax) Post First Dose of MSB001084120.8 mcg/mLGeometric Coefficient of Variation 30.3
Primary

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.

ArmMeasureValue (GEOMETRIC_MEAN)Dispersion
MSB0010841 30 mgMaximum Concentration Observed (Cmax) Post Third Dose of MSB00108415.14 mcg/mLGeometric Coefficient of Variation 34.5
MSB0010841 60 mgMaximum Concentration Observed (Cmax) Post Third Dose of MSB001084111.32 mcg/mLGeometric Coefficient of Variation 29.7
MSB0010841 120 mgMaximum Concentration Observed (Cmax) Post Third Dose of MSB001084119.74 mcg/mLGeometric Coefficient of Variation 31.3
MSB0010841 240 mgMaximum Concentration Observed (Cmax) Post Third Dose of MSB001084137.93 mcg/mLGeometric Coefficient of Variation 32.2
Primary

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.

ArmMeasureValue (GEOMETRIC_MEAN)Dispersion
MSB0010841 30 mgMaximum Observed Concentration (Cmax) Post Second Dose of MSB00108414.26 mcg/mLGeometric Coefficient of Variation 32.7
MSB0010841 60 mgMaximum Observed Concentration (Cmax) Post Second Dose of MSB00108419.06 mcg/mLGeometric Coefficient of Variation 24.2
MSB0010841 120 mgMaximum Observed Concentration (Cmax) Post Second Dose of MSB001084118.59 mcg/mLGeometric Coefficient of Variation 23.1
MSB0010841 240 mgMaximum Observed Concentration (Cmax) Post Second Dose of MSB001084130.98 mcg/mLGeometric Coefficient of Variation 25.3
Primary

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.

ArmMeasureValue (GEOMETRIC_MEAN)Dispersion
MSB0010841 30 mgMean Residence Time (MRT0-t) Post First Dose of MSB00108416.528 dayGeometric Coefficient of Variation 3.6
MSB0010841 60 mgMean Residence Time (MRT0-t) Post First Dose of MSB00108416.691 dayGeometric Coefficient of Variation 8.1
MSB0010841 120 mgMean Residence Time (MRT0-t) Post First Dose of MSB00108416.638 dayGeometric Coefficient of Variation 5.7
MSB0010841 240 mgMean Residence Time (MRT0-t) Post First Dose of MSB00108416.771 dayGeometric Coefficient of Variation 5.3
Primary

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.

ArmMeasureValue (GEOMETRIC_MEAN)Dispersion
MSB0010841 30 mgMean Residence Time (MRT0-t) Post Third Dose of MSB001084117.57 dayGeometric Coefficient of Variation 11.2
MSB0010841 60 mgMean Residence Time (MRT0-t) Post Third Dose of MSB001084115.68 dayGeometric Coefficient of Variation 16.3
MSB0010841 120 mgMean Residence Time (MRT0-t) Post Third Dose of MSB001084119.26 dayGeometric Coefficient of Variation 32
MSB0010841 240 mgMean Residence Time (MRT0-t) Post Third Dose of MSB001084116.38 dayGeometric Coefficient of Variation 11.3
Primary

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.

ArmMeasureValue (GEOMETRIC_MEAN)Dispersion
MSB0010841 30 mgMean Residence Time of Drug in the Body From Time Zero Extrapolated to Infinity (MRT(0-inf) Post Third Dose of MSB001084117.57 dayGeometric Coefficient of Variation 11.2
MSB0010841 60 mgMean Residence Time of Drug in the Body From Time Zero Extrapolated to Infinity (MRT(0-inf) Post Third Dose of MSB001084115.68 dayGeometric Coefficient of Variation 16.3
MSB0010841 120 mgMean Residence Time of Drug in the Body From Time Zero Extrapolated to Infinity (MRT(0-inf) Post Third Dose of MSB001084119.26 dayGeometric Coefficient of Variation 32
MSB0010841 240 mgMean Residence Time of Drug in the Body From Time Zero Extrapolated to Infinity (MRT(0-inf) Post Third Dose of MSB001084116.38 dayGeometric Coefficient of Variation 11.3
Primary

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.

ArmMeasureValue (MEAN)Dispersion
MSB0010841 30 mgMinimum Concentration Observed (Cmin) During First Dosing Interval of MSB00108410.01 mcg/mLStandard Deviation 0.036
MSB0010841 60 mgMinimum Concentration Observed (Cmin) During First Dosing Interval of MSB00108410.00 mcg/mLStandard Deviation 0
MSB0010841 120 mgMinimum Concentration Observed (Cmin) During First Dosing Interval of MSB00108410.00 mcg/mLStandard Deviation 0
MSB0010841 240 mgMinimum Concentration Observed (Cmin) During First Dosing Interval of MSB00108410.00 mcg/mLStandard Deviation 0
Primary

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.

ArmMeasureValue (MEAN)Dispersion
MSB0010841 30 mgMinimum Concentration Observed (Cmin) During Third Dosing Interval of MSB00108412.30 mcg/mLStandard Deviation 0.6
MSB0010841 60 mgMinimum Concentration Observed (Cmin) During Third Dosing Interval of MSB00108414.34 mcg/mLStandard Deviation 1.4
MSB0010841 120 mgMinimum Concentration Observed (Cmin) During Third Dosing Interval of MSB001084110.03 mcg/mLStandard Deviation 4.95
MSB0010841 240 mgMinimum Concentration Observed (Cmin) During Third Dosing Interval of MSB001084116.17 mcg/mLStandard Deviation 4.84
Primary

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.

ArmMeasureGroupValue (MEAN)Dispersion
MSB0010841 30 mgMSB0010841 Serum Concentration Over Time After First Dose96 hour (n=8,8,8,8)3155.8 nanogram/milliliter (ng/mL)Standard Deviation 879.56
MSB0010841 30 mgMSB0010841 Serum Concentration Over Time After First Dose72 hour (n=8,8,7,8)3190.4 nanogram/milliliter (ng/mL)Standard Deviation 810.18
MSB0010841 30 mgMSB0010841 Serum Concentration Over Time After First Dose336 hour (n=8,8,8,8)1704.3 nanogram/milliliter (ng/mL)Standard Deviation 429.78
MSB0010841 30 mgMSB0010841 Serum Concentration Over Time After First Dose24 hour (n=8,8,8,9)2788.4 nanogram/milliliter (ng/mL)Standard Deviation 895.89
MSB0010841 30 mgMSB0010841 Serum Concentration Over Time After First Dose12 hour (n=8,8,8,9)1793.3 nanogram/milliliter (ng/mL)Standard Deviation 761.23
MSB0010841 30 mgMSB0010841 Serum Concentration Over Time After First Dose6 hour (n=8,8,8,9)907.5 nanogram/milliliter (ng/mL)Standard Deviation 523.16
MSB0010841 30 mgMSB0010841 Serum Concentration Over Time After First Dose168 hour (n=8,8,8,8)2665.5 nanogram/milliliter (ng/mL)Standard Deviation 605.89
MSB0010841 30 mgMSB0010841 Serum Concentration Over Time After First Dose32 hour (n=8,8,8,9)3037.3 nanogram/milliliter (ng/mL)Standard Deviation 820.76
MSB0010841 30 mgMSB0010841 Serum Concentration Over Time After First Dose0 hour (n=8,8,8,9)12.6 nanogram/milliliter (ng/mL)Standard Deviation 35.71
MSB0010841 60 mgMSB0010841 Serum Concentration Over Time After First Dose32 hour (n=8,8,8,9)6028.1 nanogram/milliliter (ng/mL)Standard Deviation 2269.66
MSB0010841 60 mgMSB0010841 Serum Concentration Over Time After First Dose96 hour (n=8,8,8,8)6423.8 nanogram/milliliter (ng/mL)Standard Deviation 1824.46
MSB0010841 60 mgMSB0010841 Serum Concentration Over Time After First Dose72 hour (n=8,8,7,8)6492.9 nanogram/milliliter (ng/mL)Standard Deviation 1472.29
MSB0010841 60 mgMSB0010841 Serum Concentration Over Time After First Dose6 hour (n=8,8,8,9)2097.1 nanogram/milliliter (ng/mL)Standard Deviation 1391.43
MSB0010841 60 mgMSB0010841 Serum Concentration Over Time After First Dose0 hour (n=8,8,8,9)0.0 nanogram/milliliter (ng/mL)Standard Deviation 0
MSB0010841 60 mgMSB0010841 Serum Concentration Over Time After First Dose12 hour (n=8,8,8,9)3339.6 nanogram/milliliter (ng/mL)Standard Deviation 1671.29
MSB0010841 60 mgMSB0010841 Serum Concentration Over Time After First Dose336 hour (n=8,8,8,8)3951.0 nanogram/milliliter (ng/mL)Standard Deviation 1353.92
MSB0010841 60 mgMSB0010841 Serum Concentration Over Time After First Dose168 hour (n=8,8,8,8)5179.5 nanogram/milliliter (ng/mL)Standard Deviation 1126.74
MSB0010841 60 mgMSB0010841 Serum Concentration Over Time After First Dose24 hour (n=8,8,8,9)5047.8 nanogram/milliliter (ng/mL)Standard Deviation 1600.25
MSB0010841 120 mgMSB0010841 Serum Concentration Over Time After First Dose32 hour (n=8,8,8,9)11372.4 nanogram/milliliter (ng/mL)Standard Deviation 3499.37
MSB0010841 120 mgMSB0010841 Serum Concentration Over Time After First Dose0 hour (n=8,8,8,9)0.0 nanogram/milliliter (ng/mL)Standard Deviation 0
MSB0010841 120 mgMSB0010841 Serum Concentration Over Time After First Dose6 hour (n=8,8,8,9)2315.5 nanogram/milliliter (ng/mL)Standard Deviation 787.02
MSB0010841 120 mgMSB0010841 Serum Concentration Over Time After First Dose12 hour (n=8,8,8,9)4983.1 nanogram/milliliter (ng/mL)Standard Deviation 1501.41
MSB0010841 120 mgMSB0010841 Serum Concentration Over Time After First Dose24 hour (n=8,8,8,9)9131.3 nanogram/milliliter (ng/mL)Standard Deviation 2838.02
MSB0010841 120 mgMSB0010841 Serum Concentration Over Time After First Dose72 hour (n=8,8,7,8)11284.1 nanogram/milliliter (ng/mL)Standard Deviation 2562.84
MSB0010841 120 mgMSB0010841 Serum Concentration Over Time After First Dose96 hour (n=8,8,8,8)11790.0 nanogram/milliliter (ng/mL)Standard Deviation 3319.36
MSB0010841 120 mgMSB0010841 Serum Concentration Over Time After First Dose168 hour (n=8,8,8,8)10318.6 nanogram/milliliter (ng/mL)Standard Deviation 2837.81
MSB0010841 120 mgMSB0010841 Serum Concentration Over Time After First Dose336 hour (n=8,8,8,8)6768.4 nanogram/milliliter (ng/mL)Standard Deviation 2846.24
MSB0010841 240 mgMSB0010841 Serum Concentration Over Time After First Dose96 hour (n=8,8,8,8)18732.9 nanogram/milliliter (ng/mL)Standard Deviation 4670.66
MSB0010841 240 mgMSB0010841 Serum Concentration Over Time After First Dose24 hour (n=8,8,8,9)15357.6 nanogram/milliliter (ng/mL)Standard Deviation 5295.18
MSB0010841 240 mgMSB0010841 Serum Concentration Over Time After First Dose12 hour (n=8,8,8,9)9780.3 nanogram/milliliter (ng/mL)Standard Deviation 4698.97
MSB0010841 240 mgMSB0010841 Serum Concentration Over Time After First Dose336 hour (n=8,8,8,8)11605.8 nanogram/milliliter (ng/mL)Standard Deviation 2065.58
MSB0010841 240 mgMSB0010841 Serum Concentration Over Time After First Dose168 hour (n=8,8,8,8)17761.9 nanogram/milliliter (ng/mL)Standard Deviation 3072.48
MSB0010841 240 mgMSB0010841 Serum Concentration Over Time After First Dose6 hour (n=8,8,8,9)4858.8 nanogram/milliliter (ng/mL)Standard Deviation 2326.35
MSB0010841 240 mgMSB0010841 Serum Concentration Over Time After First Dose72 hour (n=8,8,7,8)20536.6 nanogram/milliliter (ng/mL)Standard Deviation 6716.38
MSB0010841 240 mgMSB0010841 Serum Concentration Over Time After First Dose32 hour (n=8,8,8,9)17135.2 nanogram/milliliter (ng/mL)Standard Deviation 6032.66
MSB0010841 240 mgMSB0010841 Serum Concentration Over Time After First Dose0 hour (n=8,8,8,9)0.0 nanogram/milliliter (ng/mL)Standard Deviation 0
Primary

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.

ArmMeasureGroupValue (MEAN)Dispersion
MSB0010841 30 mgMSB0010841 Serum Concentration Over Time After Second Dose96 hour4020.5 ng/mLStandard Deviation 923.65
MSB0010841 30 mgMSB0010841 Serum Concentration Over Time After Second Dose0 hour1704.3 ng/mLStandard Deviation 429.78
MSB0010841 30 mgMSB0010841 Serum Concentration Over Time After Second Dose72 hour4309.0 ng/mLStandard Deviation 1265.45
MSB0010841 30 mgMSB0010841 Serum Concentration Over Time After Second Dose168 hour3517.8 ng/mLStandard Deviation 877.96
MSB0010841 30 mgMSB0010841 Serum Concentration Over Time After Second Dose336 hour2306.5 ng/mLStandard Deviation 588.5
MSB0010841 30 mgMSB0010841 Serum Concentration Over Time After Second Dose24 hour3808.0 ng/mLStandard Deviation 980.68
MSB0010841 60 mgMSB0010841 Serum Concentration Over Time After Second Dose336 hour4492.9 ng/mLStandard Deviation 1398.63
MSB0010841 60 mgMSB0010841 Serum Concentration Over Time After Second Dose168 hour7180.4 ng/mLStandard Deviation 1705.24
MSB0010841 60 mgMSB0010841 Serum Concentration Over Time After Second Dose0 hour3951.0 ng/mLStandard Deviation 1353.92
MSB0010841 60 mgMSB0010841 Serum Concentration Over Time After Second Dose96 hour8514.4 ng/mLStandard Deviation 1849.44
MSB0010841 60 mgMSB0010841 Serum Concentration Over Time After Second Dose72 hour9095.5 ng/mLStandard Deviation 2115.16
MSB0010841 60 mgMSB0010841 Serum Concentration Over Time After Second Dose24 hour7268.9 ng/mLStandard Deviation 3771.98
MSB0010841 120 mgMSB0010841 Serum Concentration Over Time After Second Dose168 hour14806.6 ng/mLStandard Deviation 5632.99
MSB0010841 120 mgMSB0010841 Serum Concentration Over Time After Second Dose96 hour17081.4 ng/mLStandard Deviation 5056.17
MSB0010841 120 mgMSB0010841 Serum Concentration Over Time After Second Dose336 hour10468.9 ng/mLStandard Deviation 4376.75
MSB0010841 120 mgMSB0010841 Serum Concentration Over Time After Second Dose0 hour6768.4 ng/mLStandard Deviation 2846.24
MSB0010841 120 mgMSB0010841 Serum Concentration Over Time After Second Dose24 hour15120.6 ng/mLStandard Deviation 3393.84
MSB0010841 120 mgMSB0010841 Serum Concentration Over Time After Second Dose72 hour17454.4 ng/mLStandard Deviation 4152.32
MSB0010841 240 mgMSB0010841 Serum Concentration Over Time After Second Dose168 hour22972.5 ng/mLStandard Deviation 11219.87
MSB0010841 240 mgMSB0010841 Serum Concentration Over Time After Second Dose72 hour29902.4 ng/mLStandard Deviation 7523.13
MSB0010841 240 mgMSB0010841 Serum Concentration Over Time After Second Dose24 hour27664.8 ng/mLStandard Deviation 9231.41
MSB0010841 240 mgMSB0010841 Serum Concentration Over Time After Second Dose96 hour29223.5 ng/mLStandard Deviation 8336.26
MSB0010841 240 mgMSB0010841 Serum Concentration Over Time After Second Dose0 hour11605.8 ng/mLStandard Deviation 2065.58
MSB0010841 240 mgMSB0010841 Serum Concentration Over Time After Second Dose336 hour16454.5 ng/mLStandard Deviation 4548.85
Primary

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.

ArmMeasureGroupValue (MEAN)Dispersion
MSB0010841 30 mgMSB0010841 Serum Concentration Over Time After Third Dose6 hour3483.9 ng/mLStandard Deviation 1566.88
MSB0010841 30 mgMSB0010841 Serum Concentration Over Time After Third Dose32 hour4934.5 ng/mLStandard Deviation 1256.47
MSB0010841 30 mgMSB0010841 Serum Concentration Over Time After Third Dose24 hour4533.3 ng/mLStandard Deviation 1178.14
MSB0010841 30 mgMSB0010841 Serum Concentration Over Time After Third Dose816 hour933.1 ng/mLStandard Deviation 376.76
MSB0010841 30 mgMSB0010841 Serum Concentration Over Time After Third Dose1344 hour244.8 ng/mLStandard Deviation 162.24
MSB0010841 30 mgMSB0010841 Serum Concentration Over Time After Third Dose12 hour3557.9 ng/mLStandard Deviation 1004.43
MSB0010841 30 mgMSB0010841 Serum Concentration Over Time After Third Dose168 hour4368.1 ng/mLStandard Deviation 1201.56
MSB0010841 30 mgMSB0010841 Serum Concentration Over Time After Third Dose0 hour2306.5 ng/mLStandard Deviation 588.5
MSB0010841 30 mgMSB0010841 Serum Concentration Over Time After Third Dose336 hour2680.5 ng/mLStandard Deviation 859.35
MSB0010841 30 mgMSB0010841 Serum Concentration Over Time After Third Dose1056 hour464.5 ng/mLStandard Deviation 257.13
MSB0010841 30 mgMSB0010841 Serum Concentration Over Time After Third Dose96 hour4994.9 ng/mLStandard Deviation 1448.53
MSB0010841 30 mgMSB0010841 Serum Concentration Over Time After Third Dose72 hour4936.0 ng/mLStandard Deviation 1387.5
MSB0010841 30 mgMSB0010841 Serum Concentration Over Time After Third Dose504 hour1802.0 ng/mLStandard Deviation 505.42
MSB0010841 60 mgMSB0010841 Serum Concentration Over Time After Third Dose96 hour9047.6 ng/mLStandard Deviation 2760.25
MSB0010841 60 mgMSB0010841 Serum Concentration Over Time After Third Dose0 hour4492.9 ng/mLStandard Deviation 1398.63
MSB0010841 60 mgMSB0010841 Serum Concentration Over Time After Third Dose6 hour6200.1 ng/mLStandard Deviation 1391.38
MSB0010841 60 mgMSB0010841 Serum Concentration Over Time After Third Dose336 hour5602.1 ng/mLStandard Deviation 3057.34
MSB0010841 60 mgMSB0010841 Serum Concentration Over Time After Third Dose504 hour3109.1 ng/mLStandard Deviation 1519.66
MSB0010841 60 mgMSB0010841 Serum Concentration Over Time After Third Dose816 hour1378.1 ng/mLStandard Deviation 834.66
MSB0010841 60 mgMSB0010841 Serum Concentration Over Time After Third Dose72 hour10345.6 ng/mLStandard Deviation 4586.24
MSB0010841 60 mgMSB0010841 Serum Concentration Over Time After Third Dose12 hour8615.5 ng/mLStandard Deviation 3093.46
MSB0010841 60 mgMSB0010841 Serum Concentration Over Time After Third Dose24 hour9969.9 ng/mLStandard Deviation 2494.6
MSB0010841 60 mgMSB0010841 Serum Concentration Over Time After Third Dose32 hour10762.5 ng/mLStandard Deviation 2377.88
MSB0010841 60 mgMSB0010841 Serum Concentration Over Time After Third Dose168 hour7715.4 ng/mLStandard Deviation 3019.93
MSB0010841 60 mgMSB0010841 Serum Concentration Over Time After Third Dose1056 hour658.5 ng/mLStandard Deviation 391.39
MSB0010841 60 mgMSB0010841 Serum Concentration Over Time After Third Dose1344 hour326.3 ng/mLStandard Deviation 230.87
MSB0010841 120 mgMSB0010841 Serum Concentration Over Time After Third Dose12 hour13361.0 ng/mLStandard Deviation 5959.26
MSB0010841 120 mgMSB0010841 Serum Concentration Over Time After Third Dose24 hour17523.1 ng/mLStandard Deviation 6140.31
MSB0010841 120 mgMSB0010841 Serum Concentration Over Time After Third Dose504 hour8610.6 ng/mLStandard Deviation 5991.68
MSB0010841 120 mgMSB0010841 Serum Concentration Over Time After Third Dose0 hour10417.7 ng/mLStandard Deviation 4724.84
MSB0010841 120 mgMSB0010841 Serum Concentration Over Time After Third Dose32 hour18634.9 ng/mLStandard Deviation 5713.14
MSB0010841 120 mgMSB0010841 Serum Concentration Over Time After Third Dose72 hour19813.1 ng/mLStandard Deviation 6381.27
MSB0010841 120 mgMSB0010841 Serum Concentration Over Time After Third Dose336 hour12257.6 ng/mLStandard Deviation 7468.85
MSB0010841 120 mgMSB0010841 Serum Concentration Over Time After Third Dose168 hour15585.3 ng/mLStandard Deviation 5625.65
MSB0010841 120 mgMSB0010841 Serum Concentration Over Time After Third Dose96 hour18260.1 ng/mLStandard Deviation 6602.9
MSB0010841 120 mgMSB0010841 Serum Concentration Over Time After Third Dose1344 hour1611.3 ng/mLStandard Deviation 2199.92
MSB0010841 120 mgMSB0010841 Serum Concentration Over Time After Third Dose6 hour12725.0 ng/mLStandard Deviation 5573.11
MSB0010841 120 mgMSB0010841 Serum Concentration Over Time After Third Dose816 hour4309.3 ng/mLStandard Deviation 4044.88
MSB0010841 120 mgMSB0010841 Serum Concentration Over Time After Third Dose1056 hour2599.7 ng/mLStandard Deviation 2937.08
MSB0010841 240 mgMSB0010841 Serum Concentration Over Time After Third Dose6 hour20452.3 ng/mLStandard Deviation 6683.19
MSB0010841 240 mgMSB0010841 Serum Concentration Over Time After Third Dose504 hour12472.4 ng/mLStandard Deviation 4176
MSB0010841 240 mgMSB0010841 Serum Concentration Over Time After Third Dose1056 hour2475.9 ng/mLStandard Deviation 1391.08
MSB0010841 240 mgMSB0010841 Serum Concentration Over Time After Third Dose12 hour26051.4 ng/mLStandard Deviation 8770.65
MSB0010841 240 mgMSB0010841 Serum Concentration Over Time After Third Dose24 hour33651.7 ng/mLStandard Deviation 11590.56
MSB0010841 240 mgMSB0010841 Serum Concentration Over Time After Third Dose96 hour33909.3 ng/mLStandard Deviation 10219.54
MSB0010841 240 mgMSB0010841 Serum Concentration Over Time After Third Dose168 hour31375.9 ng/mLStandard Deviation 6826.5
MSB0010841 240 mgMSB0010841 Serum Concentration Over Time After Third Dose1344 hour1345.7 ng/mLStandard Deviation 879.15
MSB0010841 240 mgMSB0010841 Serum Concentration Over Time After Third Dose32 hour38278.4 ng/mLStandard Deviation 13391.4
MSB0010841 240 mgMSB0010841 Serum Concentration Over Time After Third Dose336 hour20011.9 ng/mLStandard Deviation 6248.98
MSB0010841 240 mgMSB0010841 Serum Concentration Over Time After Third Dose0 hour16173.6 ng/mLStandard Deviation 4837.78
MSB0010841 240 mgMSB0010841 Serum Concentration Over Time After Third Dose72 hour37166.4 ng/mLStandard Deviation 10103.58
MSB0010841 240 mgMSB0010841 Serum Concentration Over Time After Third Dose816 hour5064.6 ng/mLStandard Deviation 2070.93
Primary

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.

ArmMeasureGroupValue (NUMBER)
MSB0010841 30 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 22 Indurations: none (n=8,8,8,8,8)8 subjects
MSB0010841 30 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 1 Redness: mild (n=8,8,8,9,8)0 subjects
MSB0010841 30 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 1 Redness: none (n=8,8,8,9,8)8 subjects
MSB0010841 30 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 1 Itching: mild (n=8,8,8,9,8)0 subjects
MSB0010841 30 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 30 Redness: none (n==8,8,7,7,8)8 subjects
MSB0010841 30 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 22 Bruising: mild (n=8,8,8,8,8)0 subjects
MSB0010841 30 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 15 Swelling: none (n=8,8,8,8,8)8 subjects
MSB0010841 30 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 15 Redness: moderate (n=8,8,8,8,8)0 subjects
MSB0010841 30 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 43 Indurations: none (n=8,8,8,8,8)8 subjects
MSB0010841 30 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 30 Redness: moderate (n=8,8,7,7,8)0 subjects
MSB0010841 30 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 15 Indurations: none (n=8,8,8,8,8)8 subjects
MSB0010841 30 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 43 Bruising: none (n=8,8,8,8,8)8 subjects
MSB0010841 30 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 36 Itching: none (n=7,8,7,6,8)7 subjects
MSB0010841 30 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 36 Indurations: none (n=8,8,7,7,7)8 subjects
MSB0010841 30 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 30 Swelling: none (n=8,8,7,7,8)8 subjects
MSB0010841 30 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 29 Itching: none (n=8,8,8,7,8)8 subjects
MSB0010841 30 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 36 Bruising: mild (n=7,8,7,7,8)0 subjects
MSB0010841 30 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 36 Bruising: none (n=7,8,7,7,8)7 subjects
MSB0010841 30 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 22 Redness: severe (n=8,8,8,8,8)0 subjects
MSB0010841 30 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 22 Bruising: none (n=8,8,8,8,8)8 subjects
MSB0010841 30 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 29 Bruising: none (n=8,8,8,7,8)8 subjects
MSB0010841 30 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 16 Swelling: mild (n=8,8,8,8,8)0 subjects
MSB0010841 30 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 16 Swelling: none (n=8,8,8,8,8)8 subjects
MSB0010841 30 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 1 Itching: none (n=8,8,8,9,8)8 subjects
MSB0010841 30 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 15 Redness: mild (n=8,8,8,8,8)0 subjects
MSB0010841 30 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 1 Indurations: none (n=8,8,8,9,8)8 subjects
MSB0010841 30 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 1 Indurations: mild (n=8,8,8,9,8)0 subjects
MSB0010841 30 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 22 Redness: none (n=8,8,8,8,8)8 subjects
MSB0010841 30 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 29 Redness: none (n=8,8,8,8,8)8 subjects
MSB0010841 30 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 22 Itching: mild (n=8,8,8,8,8)1 subjects
MSB0010841 30 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 1 Bruising: none (n=8,8,8,9,8)8 subjects
MSB0010841 30 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 43 Swelling: none (n=8,8,8,8,8)8 subjects
MSB0010841 30 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 43 Redness: moderate (n=8,8,8,8,8)0 subjects
MSB0010841 30 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 43 Redness: none (n=8,8,8,8,8)8 subjects
MSB0010841 30 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 29 Redness: mild (n=8,8,8,8,8)0 subjects
MSB0010841 30 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 22 Swelling: severe (n=8,8,8,8,8)0 subjects
MSB0010841 30 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 16 Redness: mild (n=8,8,8,8,8)1 subjects
MSB0010841 30 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 16 Redness: none (n=8,8,8,8,8)7 subjects
MSB0010841 30 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 16 Itching: none (n=8,8,8,8,8)8 subjects
MSB0010841 30 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 29 Redness: moderate (n=8,8,8,8,8)0 subjects
MSB0010841 30 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 22 Itching: none (n=8,8,8,8,8)7 subjects
MSB0010841 30 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 16 Indurations: none (n=8,8,8,8,8)8 subjects
MSB0010841 30 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 16 Bruising: mild (n=8,8,8,8,8)0 subjects
MSB0010841 30 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 43 Itching: none (8,8,8,8,8)8 subjects
MSB0010841 30 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 16 Bruising: none (n=8,8,8,8,8)8 subjects
MSB0010841 30 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 29 Swelling: none (n=8,8,8,7,8)8 subjects
MSB0010841 30 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 15 Itching: none (n=8,8,8,8,8)8 subjects
MSB0010841 30 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 15 Bruising: none (n=8,8,8,8,8)8 subjects
MSB0010841 30 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 8 Swelling: none (n=8,8,8,8,8)8 subjects
MSB0010841 30 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 8 Redness: mild (n=8,8,8,8,8)1 subjects
MSB0010841 30 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 29 Swelling: mild (n=8,8,8,7,8)0 subjects
MSB0010841 30 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 22 Indurations: severe (n=8,8,8,8,8)0 subjects
MSB0010841 30 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 8 Redness: none (n=8,8,8,8,8)7 subjects
MSB0010841 30 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 8 Itching: none (n=8,8,8,8,8)8 subjects
MSB0010841 30 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 8 Indurations: none (n=8,8,8,8,8)8 subjects
MSB0010841 30 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 30 Bruising: none (n=8,8,8,7,8)8 subjects
MSB0010841 30 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 29 Indurations: none (n=8,8,7,7,8)8 subjects
MSB0010841 30 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 8 Bruising: none (n=8,8,8,8,8)8 subjects
MSB0010841 30 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 2 Swelling: none (n=8,8,8,9,8)8 subjects
MSB0010841 30 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 2 Redness: none (n=8,8,8,9,8)8 subjects
MSB0010841 30 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 30 Bruising: mild (n=8,8,8,7,8)0 subjects
MSB0010841 30 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 15 Redness: none (n=8,8,8,8,8)8 subjects
MSB0010841 30 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 2 Itching: none (n=8,8,8,9,8)8 subjects
MSB0010841 30 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 2 Indurations: none (n=8,8,8,9,8)8 subjects
MSB0010841 30 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 2 Bruising: mild (n=8,8,8,9,8)3 subjects
MSB0010841 30 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 30 Indurations: none (n=8,8,7,7,8)8 subjects
MSB0010841 30 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 22 Swelling: none (n=8,8,8,8,8)8 subjects
MSB0010841 30 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 2 Bruising: none (n=8,8,8,9,8)5 subjects
MSB0010841 30 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 1 Swelling: mild (n=8,8,8,9,8)0 subjects
MSB0010841 30 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 1 Swelling: none (n=8,8,8,9,8)8 subjects
MSB0010841 30 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 30 Itching: none (n=8,8,7,7,8)8 subjects
MSB0010841 60 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 16 Bruising: none (n=8,8,8,8,8)7 subjects
MSB0010841 60 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 29 Bruising: none (n=8,8,8,7,8)8 subjects
MSB0010841 60 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 29 Indurations: none (n=8,8,7,7,8)8 subjects
MSB0010841 60 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 29 Itching: none (n=8,8,8,7,8)8 subjects
MSB0010841 60 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 15 Redness: none (n=8,8,8,8,8)7 subjects
MSB0010841 60 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 15 Redness: mild (n=8,8,8,8,8)1 subjects
MSB0010841 60 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 29 Redness: none (n=8,8,8,8,8)8 subjects
MSB0010841 60 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 29 Redness: mild (n=8,8,8,8,8)0 subjects
MSB0010841 60 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 29 Redness: moderate (n=8,8,8,8,8)0 subjects
MSB0010841 60 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 29 Swelling: none (n=8,8,8,7,8)8 subjects
MSB0010841 60 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 29 Swelling: mild (n=8,8,8,7,8)0 subjects
MSB0010841 60 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 30 Bruising: none (n=8,8,8,7,8)8 subjects
MSB0010841 60 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 30 Bruising: mild (n=8,8,8,7,8)0 subjects
MSB0010841 60 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 30 Indurations: none (n=8,8,7,7,8)8 subjects
MSB0010841 60 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 30 Itching: none (n=8,8,7,7,8)8 subjects
MSB0010841 60 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 30 Redness: none (n==8,8,7,7,8)8 subjects
MSB0010841 60 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 30 Redness: moderate (n=8,8,7,7,8)0 subjects
MSB0010841 60 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 30 Swelling: none (n=8,8,7,7,8)8 subjects
MSB0010841 60 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 36 Bruising: none (n=7,8,7,7,8)8 subjects
MSB0010841 60 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 36 Bruising: mild (n=7,8,7,7,8)0 subjects
MSB0010841 60 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 36 Indurations: none (n=8,8,7,7,7)8 subjects
MSB0010841 60 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 36 Itching: none (n=7,8,7,6,8)8 subjects
MSB0010841 60 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 43 Bruising: none (n=8,8,8,8,8)8 subjects
MSB0010841 60 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 43 Indurations: none (n=8,8,8,8,8)8 subjects
MSB0010841 60 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 15 Redness: moderate (n=8,8,8,8,8)0 subjects
MSB0010841 60 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 15 Swelling: none (n=8,8,8,8,8)8 subjects
MSB0010841 60 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 1 Itching: mild (n=8,8,8,9,8)0 subjects
MSB0010841 60 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 1 Redness: none (n=8,8,8,9,8)7 subjects
MSB0010841 60 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 1 Redness: mild (n=8,8,8,9,8)1 subjects
MSB0010841 60 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 1 Swelling: none (n=8,8,8,9,8)7 subjects
MSB0010841 60 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 1 Swelling: mild (n=8,8,8,9,8)1 subjects
MSB0010841 60 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 2 Bruising: none (n=8,8,8,9,8)8 subjects
MSB0010841 60 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 2 Bruising: mild (n=8,8,8,9,8)0 subjects
MSB0010841 60 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 2 Indurations: none (n=8,8,8,9,8)8 subjects
MSB0010841 60 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 2 Itching: none (n=8,8,8,9,8)8 subjects
MSB0010841 60 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 2 Redness: none (n=8,8,8,9,8)8 subjects
MSB0010841 60 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 2 Swelling: none (n=8,8,8,9,8)8 subjects
MSB0010841 60 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 8 Bruising: none (n=8,8,8,8,8)8 subjects
MSB0010841 60 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 8 Indurations: none (n=8,8,8,8,8)8 subjects
MSB0010841 60 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 8 Itching: none (n=8,8,8,8,8)8 subjects
MSB0010841 60 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 8 Redness: none (n=8,8,8,8,8)8 subjects
MSB0010841 60 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 8 Redness: mild (n=8,8,8,8,8)0 subjects
MSB0010841 60 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 8 Swelling: none (n=8,8,8,8,8)8 subjects
MSB0010841 60 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 16 Bruising: mild (n=8,8,8,8,8)1 subjects
MSB0010841 60 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 16 Indurations: none (n=8,8,8,8,8)8 subjects
MSB0010841 60 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 16 Itching: none (n=8,8,8,8,8)8 subjects
MSB0010841 60 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 16 Redness: none (n=8,8,8,8,8)8 subjects
MSB0010841 60 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 16 Redness: mild (n=8,8,8,8,8)0 subjects
MSB0010841 60 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 43 Itching: none (8,8,8,8,8)8 subjects
MSB0010841 60 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 43 Redness: none (n=8,8,8,8,8)8 subjects
MSB0010841 60 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 43 Redness: moderate (n=8,8,8,8,8)0 subjects
MSB0010841 60 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 43 Swelling: none (n=8,8,8,8,8)8 subjects
MSB0010841 60 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 1 Indurations: mild (n=8,8,8,9,8)0 subjects
MSB0010841 60 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 1 Bruising: none (n=8,8,8,9,8)8 subjects
MSB0010841 60 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 1 Indurations: none (n=8,8,8,9,8)8 subjects
MSB0010841 60 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 1 Itching: none (n=8,8,8,9,8)8 subjects
MSB0010841 60 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 16 Swelling: none (n=8,8,8,8,8)8 subjects
MSB0010841 60 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 16 Swelling: mild (n=8,8,8,8,8)0 subjects
MSB0010841 60 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 22 Bruising: none (n=8,8,8,8,8)8 subjects
MSB0010841 60 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 15 Bruising: none (n=8,8,8,8,8)8 subjects
MSB0010841 60 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 22 Bruising: mild (n=8,8,8,8,8)0 subjects
MSB0010841 60 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 22 Indurations: none (n=8,8,8,8,8)8 subjects
MSB0010841 60 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 15 Indurations: none (n=8,8,8,8,8)8 subjects
MSB0010841 60 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 22 Indurations: severe (n=8,8,8,8,8)0 subjects
MSB0010841 60 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 15 Itching: none (n=8,8,8,8,8)8 subjects
MSB0010841 60 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 22 Itching: none (n=8,8,8,8,8)8 subjects
MSB0010841 60 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 22 Itching: mild (n=8,8,8,8,8)0 subjects
MSB0010841 60 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 22 Redness: none (n=8,8,8,8,8)8 subjects
MSB0010841 60 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 22 Redness: severe (n=8,8,8,8,8)0 subjects
MSB0010841 60 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 22 Swelling: none (n=8,8,8,8,8)8 subjects
MSB0010841 60 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 22 Swelling: severe (n=8,8,8,8,8)0 subjects
MSB0010841 120 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 8 Swelling: none (n=8,8,8,8,8)8 subjects
MSB0010841 120 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 15 Redness: moderate (n=8,8,8,8,8)1 subjects
MSB0010841 120 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 22 Redness: none (n=8,8,8,8,8)7 subjects
MSB0010841 120 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 29 Swelling: none (n=8,8,8,7,8)7 subjects
MSB0010841 120 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 1 Indurations: mild (n=8,8,8,9,8)1 subjects
MSB0010841 120 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 1 Itching: mild (n=8,8,8,9,8)0 subjects
MSB0010841 120 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 1 Bruising: none (n=8,8,8,9,8)8 subjects
MSB0010841 120 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 15 Itching: none (n=8,8,8,8,8)8 subjects
MSB0010841 120 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 43 Indurations: none (n=8,8,8,8,8)8 subjects
MSB0010841 120 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 16 Bruising: none (n=8,8,8,8,8)8 subjects
MSB0010841 120 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 2 Indurations: none (n=8,8,8,9,8)8 subjects
MSB0010841 120 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 1 Indurations: none (n=8,8,8,9,8)7 subjects
MSB0010841 120 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 29 Redness: moderate (n=8,8,8,8,8)0 subjects
MSB0010841 120 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 30 Itching: none (n=8,8,7,7,8)0 subjects
MSB0010841 120 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 16 Bruising: mild (n=8,8,8,8,8)0 subjects
MSB0010841 120 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 22 Bruising: mild (n=8,8,8,8,8)0 subjects
MSB0010841 120 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 29 Redness: none (n=8,8,8,8,8)6 subjects
MSB0010841 120 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 30 Bruising: mild (n=8,8,8,7,8)1 subjects
MSB0010841 120 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 22 Itching: none (n=8,8,8,8,8)8 subjects
MSB0010841 120 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 16 Indurations: none (n=8,8,8,8,8)8 subjects
MSB0010841 120 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 22 Swelling: severe (n=8,8,8,8,8)1 subjects
MSB0010841 120 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 43 Swelling: none (n=8,8,8,8,8)8 subjects
MSB0010841 120 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 43 Redness: moderate (n=8,8,8,8,8)1 subjects
MSB0010841 120 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 2 Itching: none (n=8,8,8,9,8)8 subjects
MSB0010841 120 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 16 Itching: none (n=8,8,8,8,8)8 subjects
MSB0010841 120 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 22 Indurations: none (n=8,8,8,8,8)7 subjects
MSB0010841 120 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 15 Redness: mild (n=8,8,8,8,8)0 subjects
MSB0010841 120 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 43 Bruising: none (n=8,8,8,8,8)8 subjects
MSB0010841 120 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 43 Redness: none (n=8,8,8,8,8)7 subjects
MSB0010841 120 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 16 Redness: none (n=8,8,8,8,8)8 subjects
MSB0010841 120 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 30 Redness: moderate (n=8,8,7,7,8)0 subjects
MSB0010841 120 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 22 Itching: mild (n=8,8,8,8,8)0 subjects
MSB0010841 120 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 29 Redness: mild (n=8,8,8,8,8)2 subjects
MSB0010841 120 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 1 Swelling: mild (n=8,8,8,9,8)0 subjects
MSB0010841 120 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 16 Redness: mild (n=8,8,8,8,8)0 subjects
MSB0010841 120 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 43 Itching: none (8,8,8,8,8)8 subjects
MSB0010841 120 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 2 Redness: none (n=8,8,8,9,8)8 subjects
MSB0010841 120 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 1 Redness: none (n=8,8,8,9,8)8 subjects
MSB0010841 120 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 36 Itching: none (n=7,8,7,6,8)7 subjects
MSB0010841 120 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 29 Indurations: none (n=8,8,7,7,8)7 subjects
MSB0010841 120 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 36 Indurations: none (n=8,8,7,7,7)7 subjects
MSB0010841 120 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 2 Swelling: none (n=8,8,8,9,8)8 subjects
MSB0010841 120 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 30 Indurations: none (n=8,8,7,7,8)7 subjects
MSB0010841 120 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 36 Bruising: mild (n=7,8,7,7,8)0 subjects
MSB0010841 120 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 30 Bruising: none (n=8,8,8,7,8)7 subjects
MSB0010841 120 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 15 Indurations: none (n=8,8,8,8,8)8 subjects
MSB0010841 120 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 8 Bruising: none (n=8,8,8,8,8)8 subjects
MSB0010841 120 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 2 Bruising: none (n=8,8,8,9,8)8 subjects
MSB0010841 120 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 30 Swelling: none (n=8,8,7,7,8)7 subjects
MSB0010841 120 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 36 Bruising: none (n=7,8,7,7,8)7 subjects
MSB0010841 120 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 22 Swelling: none (n=8,8,8,8,8)7 subjects
MSB0010841 120 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 8 Indurations: none (n=8,8,8,8,8)8 subjects
MSB0010841 120 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 15 Bruising: none (n=8,8,8,8,8)8 subjects
MSB0010841 120 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 22 Redness: severe (n=8,8,8,8,8)1 subjects
MSB0010841 120 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 1 Swelling: none (n=8,8,8,9,8)8 subjects
MSB0010841 120 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 22 Indurations: severe (n=8,8,8,8,8)1 subjects
MSB0010841 120 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 8 Itching: none (n=8,8,8,8,8)8 subjects
MSB0010841 120 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 1 Itching: none (n=8,8,8,9,8)8 subjects
MSB0010841 120 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 22 Bruising: none (n=8,8,8,8,8)8 subjects
MSB0010841 120 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 29 Swelling: mild (n=8,8,8,7,8)1 subjects
MSB0010841 120 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 15 Swelling: none (n=8,8,8,8,8)8 subjects
MSB0010841 120 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 8 Redness: none (n=8,8,8,8,8)8 subjects
MSB0010841 120 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 30 Redness: none (n==8,8,7,7,8)7 subjects
MSB0010841 120 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 29 Itching: none (n=8,8,8,7,8)8 subjects
MSB0010841 120 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 16 Swelling: mild (n=8,8,8,8,8)1 subjects
MSB0010841 120 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 15 Redness: none (n=8,8,8,8,8)7 subjects
MSB0010841 120 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 8 Redness: mild (n=8,8,8,8,8)0 subjects
MSB0010841 120 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 2 Bruising: mild (n=8,8,8,9,8)0 subjects
MSB0010841 120 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 16 Swelling: none (n=8,8,8,8,8)7 subjects
MSB0010841 120 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 1 Redness: mild (n=8,8,8,9,8)0 subjects
MSB0010841 120 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 29 Bruising: none (n=8,8,8,7,8)8 subjects
MSB0010841 240 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 8 Indurations: none (n=8,8,8,8,8)8 subjects
MSB0010841 240 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 1 Redness: mild (n=8,8,8,9,8)1 subjects
MSB0010841 240 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 1 Swelling: none (n=8,8,8,9,8)9 subjects
MSB0010841 240 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 30 Indurations: none (n=8,8,7,7,8)7 subjects
MSB0010841 240 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 1 Swelling: mild (n=8,8,8,9,8)0 subjects
MSB0010841 240 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 22 Indurations: none (n=8,8,8,8,8)8 subjects
MSB0010841 240 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 2 Bruising: none (n=8,8,8,9,8)9 subjects
MSB0010841 240 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 2 Bruising: mild (n=8,8,8,9,8)0 subjects
MSB0010841 240 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 30 Bruising: mild (n=8,8,8,7,8)1 subjects
MSB0010841 240 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 2 Indurations: none (n=8,8,8,9,8)9 subjects
MSB0010841 240 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 2 Itching: none (n=8,8,8,9,8)9 subjects
MSB0010841 240 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 15 Indurations: none (n=8,8,8,8,8)8 subjects
MSB0010841 240 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 2 Redness: none (n=8,8,8,9,8)9 subjects
MSB0010841 240 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 30 Bruising: none (n=8,8,8,7,8)6 subjects
MSB0010841 240 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 2 Swelling: none (n=8,8,8,9,8)9 subjects
MSB0010841 240 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 29 Bruising: none (n=8,8,8,7,8)7 subjects
MSB0010841 240 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 8 Bruising: none (n=8,8,8,8,8)8 subjects
MSB0010841 240 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 29 Swelling: mild (n=8,8,8,7,8)0 subjects
MSB0010841 240 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 8 Itching: none (n=8,8,8,8,8)8 subjects
MSB0010841 240 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 22 Indurations: severe (n=8,8,8,8,8)0 subjects
MSB0010841 240 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 8 Redness: none (n=8,8,8,8,8)8 subjects
MSB0010841 240 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 8 Redness: mild (n=8,8,8,8,8)0 subjects
MSB0010841 240 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 29 Swelling: none (n=8,8,8,7,8)7 subjects
MSB0010841 240 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 8 Swelling: none (n=8,8,8,8,8)8 subjects
MSB0010841 240 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 15 Swelling: none (n=8,8,8,8,8)8 subjects
MSB0010841 240 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 29 Redness: moderate (n=8,8,8,8,8)1 subjects
MSB0010841 240 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 16 Bruising: none (n=8,8,8,8,8)7 subjects
MSB0010841 240 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 22 Swelling: none (n=8,8,8,8,8)8 subjects
MSB0010841 240 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 16 Bruising: mild (n=8,8,8,8,8)1 subjects
MSB0010841 240 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 15 Redness: mild (n=8,8,8,8,8)0 subjects
MSB0010841 240 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 16 Indurations: none (n=8,8,8,8,8)8 subjects
MSB0010841 240 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 22 Itching: none (n=8,8,8,8,8)8 subjects
MSB0010841 240 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 16 Itching: none (n=8,8,8,8,8)8 subjects
MSB0010841 240 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 29 Redness: mild (n=8,8,8,8,8)2 subjects
MSB0010841 240 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 16 Redness: none (n=8,8,8,8,8)8 subjects
MSB0010841 240 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 15 Itching: none (n=8,8,8,8,8)8 subjects
MSB0010841 240 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 43 Itching: none (8,8,8,8,8)8 subjects
MSB0010841 240 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 22 Itching: mild (n=8,8,8,8,8)0 subjects
MSB0010841 240 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 43 Redness: moderate (n=8,8,8,8,8)0 subjects
MSB0010841 240 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 29 Redness: none (n=8,8,8,8,8)5 subjects
MSB0010841 240 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 43 Swelling: none (n=8,8,8,8,8)8 subjects
MSB0010841 240 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 1 Indurations: none (n=8,8,8,9,8)9 subjects
MSB0010841 240 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 43 Redness: none (n=8,8,8,8,8)8 subjects
MSB0010841 240 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 1 Bruising: none (n=8,8,8,9,8)9 subjects
MSB0010841 240 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 1 Indurations: mild (n=8,8,8,9,8)0 subjects
MSB0010841 240 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 29 Itching: none (n=8,8,8,7,8)7 subjects
MSB0010841 240 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 16 Redness: mild (n=8,8,8,8,8)0 subjects
MSB0010841 240 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 22 Redness: none (n=8,8,8,8,8)8 subjects
MSB0010841 240 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 15 Redness: none (n=8,8,8,8,8)8 subjects
MSB0010841 240 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 16 Swelling: none (n=8,8,8,8,8)8 subjects
MSB0010841 240 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 16 Swelling: mild (n=8,8,8,8,8)0 subjects
MSB0010841 240 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 22 Swelling: severe (n=8,8,8,8,8)0 subjects
MSB0010841 240 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 15 Bruising: none (n=8,8,8,8,8)8 subjects
MSB0010841 240 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 30 Swelling: none (n=8,8,7,7,8)7 subjects
MSB0010841 240 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 36 Bruising: none (n=7,8,7,7,8)6 subjects
MSB0010841 240 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 22 Bruising: none (n=8,8,8,8,8)7 subjects
MSB0010841 240 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 36 Bruising: mild (n=7,8,7,7,8)1 subjects
MSB0010841 240 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 36 Indurations: none (n=8,8,7,7,7)7 subjects
MSB0010841 240 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 30 Redness: moderate (n=8,8,7,7,8)1 subjects
MSB0010841 240 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 29 Indurations: none (n=8,8,7,7,8)7 subjects
MSB0010841 240 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 36 Itching: none (n=7,8,7,6,8)6 subjects
MSB0010841 240 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 22 Redness: severe (n=8,8,8,8,8)0 subjects
MSB0010841 240 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 43 Bruising: none (n=8,8,8,8,8)8 subjects
MSB0010841 240 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 43 Indurations: none (n=8,8,8,8,8)8 subjects
MSB0010841 240 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 30 Redness: none (n==8,8,7,7,8)6 subjects
MSB0010841 240 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 22 Bruising: mild (n=8,8,8,8,8)1 subjects
MSB0010841 240 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 15 Redness: moderate (n=8,8,8,8,8)0 subjects
MSB0010841 240 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 1 Itching: none (n=8,8,8,9,8)8 subjects
MSB0010841 240 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 1 Itching: mild (n=8,8,8,9,8)1 subjects
MSB0010841 240 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 30 Itching: none (n=8,8,7,7,8)0 subjects
MSB0010841 240 mgNumber of Subjects With Local Injection Site Reactions (ISRs)Day 1 Redness: none (n=8,8,8,9,8)8 subjects
PlaceboNumber of Subjects With Local Injection Site Reactions (ISRs)Day 1 Redness: mild (n=8,8,8,9,8)2 subjects
PlaceboNumber of Subjects With Local Injection Site Reactions (ISRs)Day 16 Redness: mild (n=8,8,8,8,8)0 subjects
PlaceboNumber of Subjects With Local Injection Site Reactions (ISRs)Day 15 Redness: mild (n=8,8,8,8,8)0 subjects
PlaceboNumber of Subjects With Local Injection Site Reactions (ISRs)Day 22 Redness: none (n=8,8,8,8,8)8 subjects
PlaceboNumber of Subjects With Local Injection Site Reactions (ISRs)Day 1 Itching: mild (n=8,8,8,9,8)0 subjects
PlaceboNumber of Subjects With Local Injection Site Reactions (ISRs)Day 16 Swelling: none (n=8,8,8,8,8)8 subjects
PlaceboNumber of Subjects With Local Injection Site Reactions (ISRs)Day 22 Indurations: severe (n=8,8,8,8,8)0 subjects
PlaceboNumber of Subjects With Local Injection Site Reactions (ISRs)Day 22 Swelling: severe (n=8,8,8,8,8)0 subjects
PlaceboNumber of Subjects With Local Injection Site Reactions (ISRs)Day 29 Swelling: none (n=8,8,8,7,8)8 subjects
PlaceboNumber of Subjects With Local Injection Site Reactions (ISRs)Day 1 Redness: none (n=8,8,8,9,8)6 subjects
PlaceboNumber of Subjects With Local Injection Site Reactions (ISRs)Day 16 Swelling: mild (n=8,8,8,8,8)0 subjects
PlaceboNumber of Subjects With Local Injection Site Reactions (ISRs)Day 8 Redness: none (n=8,8,8,8,8)8 subjects
PlaceboNumber of Subjects With Local Injection Site Reactions (ISRs)Day 2 Bruising: mild (n=8,8,8,9,8)0 subjects
PlaceboNumber of Subjects With Local Injection Site Reactions (ISRs)Day 8 Itching: none (n=8,8,8,8,8)8 subjects
PlaceboNumber of Subjects With Local Injection Site Reactions (ISRs)Day 8 Indurations: none (n=8,8,8,8,8)8 subjects
PlaceboNumber of Subjects With Local Injection Site Reactions (ISRs)Day 15 Itching: none (n=8,8,8,8,8)8 subjects
PlaceboNumber of Subjects With Local Injection Site Reactions (ISRs)Day 22 Redness: severe (n=8,8,8,8,8)0 subjects
PlaceboNumber of Subjects With Local Injection Site Reactions (ISRs)Day 15 Bruising: none (n=8,8,8,8,8)8 subjects
PlaceboNumber of Subjects With Local Injection Site Reactions (ISRs)Day 30 Swelling: none (n=8,8,7,7,8)8 subjects
PlaceboNumber of Subjects With Local Injection Site Reactions (ISRs)Day 15 Redness: moderate (n=8,8,8,8,8)0 subjects
PlaceboNumber of Subjects With Local Injection Site Reactions (ISRs)Day 29 Indurations: none (n=8,8,7,7,8)8 subjects
PlaceboNumber of Subjects With Local Injection Site Reactions (ISRs)Day 29 Swelling: mild (n=8,8,8,7,8)0 subjects
PlaceboNumber of Subjects With Local Injection Site Reactions (ISRs)Day 22 Indurations: none (n=8,8,8,8,8)8 subjects
PlaceboNumber of Subjects With Local Injection Site Reactions (ISRs)Day 36 Bruising: none (n=7,8,7,7,8)8 subjects
PlaceboNumber of Subjects With Local Injection Site Reactions (ISRs)Day 8 Bruising: none (n=8,8,8,8,8)8 subjects
PlaceboNumber of Subjects With Local Injection Site Reactions (ISRs)Day 22 Bruising: mild (n=8,8,8,8,8)0 subjects
PlaceboNumber of Subjects With Local Injection Site Reactions (ISRs)Day 2 Swelling: none (n=8,8,8,9,8)8 subjects
PlaceboNumber of Subjects With Local Injection Site Reactions (ISRs)Day 30 Bruising: mild (n=8,8,8,7,8)0 subjects
PlaceboNumber of Subjects With Local Injection Site Reactions (ISRs)Day 36 Bruising: mild (n=7,8,7,7,8)0 subjects
PlaceboNumber of Subjects With Local Injection Site Reactions (ISRs)Day 30 Redness: moderate (n=8,8,7,7,8)0 subjects
PlaceboNumber of Subjects With Local Injection Site Reactions (ISRs)Day 22 Bruising: none (n=8,8,8,8,8)8 subjects
PlaceboNumber of Subjects With Local Injection Site Reactions (ISRs)Day 15 Indurations: none (n=8,8,8,8,8)8 subjects
PlaceboNumber of Subjects With Local Injection Site Reactions (ISRs)Day 2 Bruising: none (n=8,8,8,9,8)8 subjects
PlaceboNumber of Subjects With Local Injection Site Reactions (ISRs)Day 36 Indurations: none (n=8,8,7,7,7)7 subjects
PlaceboNumber of Subjects With Local Injection Site Reactions (ISRs)Day 30 Indurations: none (n=8,8,7,7,8)8 subjects
PlaceboNumber of Subjects With Local Injection Site Reactions (ISRs)Day 1 Itching: none (n=8,8,8,9,8)9 subjects
PlaceboNumber of Subjects With Local Injection Site Reactions (ISRs)Day 22 Swelling: none (n=8,8,8,8,8)8 subjects
PlaceboNumber of Subjects With Local Injection Site Reactions (ISRs)Day 2 Redness: none (n=8,8,8,9,8)8 subjects
PlaceboNumber of Subjects With Local Injection Site Reactions (ISRs)Day 43 Itching: none (8,8,8,8,8)8 subjects
PlaceboNumber of Subjects With Local Injection Site Reactions (ISRs)Day 29 Redness: none (n=8,8,8,8,8)8 subjects
PlaceboNumber of Subjects With Local Injection Site Reactions (ISRs)Day 16 Redness: none (n=8,8,8,8,8)8 subjects
PlaceboNumber of Subjects With Local Injection Site Reactions (ISRs)Day 22 Itching: none (n=8,8,8,8,8)8 subjects
PlaceboNumber of Subjects With Local Injection Site Reactions (ISRs)Day 43 Redness: none (n=8,8,8,8,8)8 subjects
PlaceboNumber of Subjects With Local Injection Site Reactions (ISRs)Day 16 Itching: none (n=8,8,8,8,8)8 subjects
PlaceboNumber of Subjects With Local Injection Site Reactions (ISRs)Day 30 Itching: none (n=8,8,7,7,8)8 subjects
PlaceboNumber of Subjects With Local Injection Site Reactions (ISRs)Day 29 Redness: mild (n=8,8,8,8,8)0 subjects
PlaceboNumber of Subjects With Local Injection Site Reactions (ISRs)Day 36 Itching: none (n=7,8,7,6,8)8 subjects
PlaceboNumber of Subjects With Local Injection Site Reactions (ISRs)Day 43 Redness: moderate (n=8,8,8,8,8)0 subjects
PlaceboNumber of Subjects With Local Injection Site Reactions (ISRs)Day 30 Bruising: none (n=8,8,8,7,8)8 subjects
PlaceboNumber of Subjects With Local Injection Site Reactions (ISRs)Day 22 Itching: mild (n=8,8,8,8,8)0 subjects
PlaceboNumber of Subjects With Local Injection Site Reactions (ISRs)Day 16 Indurations: none (n=8,8,8,8,8)8 subjects
PlaceboNumber of Subjects With Local Injection Site Reactions (ISRs)Day 1 Swelling: mild (n=8,8,8,9,8)0 subjects
PlaceboNumber of Subjects With Local Injection Site Reactions (ISRs)Day 43 Swelling: none (n=8,8,8,8,8)8 subjects
PlaceboNumber of Subjects With Local Injection Site Reactions (ISRs)Day 16 Bruising: mild (n=8,8,8,8,8)0 subjects
PlaceboNumber of Subjects With Local Injection Site Reactions (ISRs)Day 16 Bruising: none (n=8,8,8,8,8)8 subjects
PlaceboNumber of Subjects With Local Injection Site Reactions (ISRs)Day 2 Itching: none (n=8,8,8,9,8)8 subjects
PlaceboNumber of Subjects With Local Injection Site Reactions (ISRs)Day 1 Indurations: none (n=8,8,8,9,8)8 subjects
PlaceboNumber of Subjects With Local Injection Site Reactions (ISRs)Day 29 Itching: none (n=8,8,8,7,8)8 subjects
PlaceboNumber of Subjects With Local Injection Site Reactions (ISRs)Day 29 Redness: moderate (n=8,8,8,8,8)0 subjects
PlaceboNumber of Subjects With Local Injection Site Reactions (ISRs)Day 1 Swelling: none (n=8,8,8,9,8)8 subjects
PlaceboNumber of Subjects With Local Injection Site Reactions (ISRs)Day 15 Swelling: none (n=8,8,8,8,8)8 subjects
PlaceboNumber of Subjects With Local Injection Site Reactions (ISRs)Day 43 Bruising: none (n=8,8,8,8,8)8 subjects
PlaceboNumber of Subjects With Local Injection Site Reactions (ISRs)Day 43 Indurations: none (n=8,8,8,8,8)8 subjects
PlaceboNumber of Subjects With Local Injection Site Reactions (ISRs)Day 30 Redness: none (n==8,8,7,7,8)8 subjects
PlaceboNumber of Subjects With Local Injection Site Reactions (ISRs)Day 1 Bruising: none (n=8,8,8,9,8)8 subjects
PlaceboNumber of Subjects With Local Injection Site Reactions (ISRs)Day 2 Indurations: none (n=8,8,8,9,8)8 subjects
PlaceboNumber of Subjects With Local Injection Site Reactions (ISRs)Day 8 Swelling: none (n=8,8,8,8,8)8 subjects
PlaceboNumber of Subjects With Local Injection Site Reactions (ISRs)Day 29 Bruising: none (n=8,8,8,7,8)8 subjects
PlaceboNumber of Subjects With Local Injection Site Reactions (ISRs)Day 8 Redness: mild (n=8,8,8,8,8)0 subjects
PlaceboNumber of Subjects With Local Injection Site Reactions (ISRs)Day 1 Indurations: mild (n=8,8,8,9,8)0 subjects
PlaceboNumber of Subjects With Local Injection Site Reactions (ISRs)Day 15 Redness: none (n=8,8,8,8,8)8 subjects
Primary

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).

ArmMeasureValue (NUMBER)
MSB0010841 30 mgNumber of Subjects With Treatment Emergent Adverse Events (TEAEs)6 subjects
MSB0010841 60 mgNumber of Subjects With Treatment Emergent Adverse Events (TEAEs)5 subjects
MSB0010841 120 mgNumber of Subjects With Treatment Emergent Adverse Events (TEAEs)5 subjects
MSB0010841 240 mgNumber of Subjects With Treatment Emergent Adverse Events (TEAEs)6 subjects
PlaceboNumber of Subjects With Treatment Emergent Adverse Events (TEAEs)6 subjects
Primary

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.

ArmMeasureValue (MEAN)Dispersion
MSB0010841 30 mgObserved Serum Concentration Immediately Before First Dose (Cpre) of MSB00108410.01 mcg/mLStandard Deviation 0.036
MSB0010841 60 mgObserved Serum Concentration Immediately Before First Dose (Cpre) of MSB00108410.00 mcg/mLStandard Deviation 0
MSB0010841 120 mgObserved Serum Concentration Immediately Before First Dose (Cpre) of MSB00108410.00 mcg/mLStandard Deviation 0
MSB0010841 240 mgObserved Serum Concentration Immediately Before First Dose (Cpre) of MSB00108410.00 mcg/mLStandard Deviation 0
Primary

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.

ArmMeasureValue (GEOMETRIC_MEAN)Dispersion
MSB0010841 30 mgObserved Serum Concentration Immediately Before Second Dose (Cpre) of MSB00108411.65 mcg/mLGeometric Coefficient of Variation 30.2
MSB0010841 60 mgObserved Serum Concentration Immediately Before Second Dose (Cpre) of MSB00108413.74 mcg/mLGeometric Coefficient of Variation 37.9
MSB0010841 120 mgObserved Serum Concentration Immediately Before Second Dose (Cpre) of MSB00108416.34 mcg/mLGeometric Coefficient of Variation 38.3
MSB0010841 240 mgObserved Serum Concentration Immediately Before Second Dose (Cpre) of MSB001084111.44 mcg/mLGeometric Coefficient of Variation 18.1
Primary

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.

ArmMeasureValue (MEAN)Dispersion
MSB0010841 30 mgObserved Serum Concentration Immediately Before Third Dose (Cpre) of MSB00108412.31 mcg/mLStandard Deviation 0.59
MSB0010841 60 mgObserved Serum Concentration Immediately Before Third Dose (Cpre) of MSB00108414.49 mcg/mLStandard Deviation 1.4
MSB0010841 120 mgObserved Serum Concentration Immediately Before Third Dose (Cpre) of MSB001084110.42 mcg/mLStandard Deviation 4.72
MSB0010841 240 mgObserved Serum Concentration Immediately Before Third Dose (Cpre) of MSB001084116.17 mcg/mLStandard Deviation 4.84
Primary

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).

ArmMeasureValue (NUMBER)
MSB0010841 30 mgPercentage of Subjects With Anti-MSB0010841 Binding Antibodies (Anti-Drug Antibodies [ADA])30.3 percentage of subjects
MSB0010841 60 mgPercentage of Subjects With Anti-MSB0010841 Binding Antibodies (Anti-Drug Antibodies [ADA])37.5 percentage of subjects
Primary

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.

ArmMeasureValue (GEOMETRIC_MEAN)Dispersion
MSB0010841 30 mgPercentage Peak-Trough Fluctuation (PTF) Post First Dose of MSB0010841140.28 percentage fluctuationGeometric Coefficient of Variation 3.9
MSB0010841 60 mgPercentage Peak-Trough Fluctuation (PTF) Post First Dose of MSB0010841152.47 percentage fluctuationGeometric Coefficient of Variation 20.4
MSB0010841 120 mgPercentage Peak-Trough Fluctuation (PTF) Post First Dose of MSB0010841144.37 percentage fluctuationGeometric Coefficient of Variation 13
MSB0010841 240 mgPercentage Peak-Trough Fluctuation (PTF) Post First Dose of MSB0010841135.89 percentage fluctuationGeometric Coefficient of Variation 12.3
Primary

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.

ArmMeasureValue (GEOMETRIC_MEAN)Dispersion
MSB0010841 30 mgPercentage Peak-Trough Fluctuation (PTF) Post Third Dose of MSB001084175.26 percentage fluctuationGeometric Coefficient of Variation 8.5
MSB0010841 60 mgPercentage Peak-Trough Fluctuation (PTF) Post Third Dose of MSB001084195.65 percentage fluctuationGeometric Coefficient of Variation 18.9
MSB0010841 120 mgPercentage Peak-Trough Fluctuation (PTF) Post Third Dose of MSB001084171.17 percentage fluctuationGeometric Coefficient of Variation 33.1
MSB0010841 240 mgPercentage Peak-Trough Fluctuation (PTF) Post Third Dose of MSB001084176.03 percentage fluctuationGeometric Coefficient of Variation 28.6
Primary

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.

ArmMeasureValue (GEOMETRIC_MEAN)Dispersion
MSB0010841 30 mgTerminal Rate Constant (λz) Post Third Dose of MSB00108410.00 1/hourGeometric Coefficient of Variation 17.3
MSB0010841 60 mgTerminal Rate Constant (λz) Post Third Dose of MSB00108410.00 1/hourGeometric Coefficient of Variation 18.9
MSB0010841 120 mgTerminal Rate Constant (λz) Post Third Dose of MSB00108410.00 1/hourGeometric Coefficient of Variation 27.9
MSB0010841 240 mgTerminal Rate Constant (λz) Post Third Dose of MSB00108410.00 1/hourGeometric Coefficient of Variation 13.1
Primary

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.

ArmMeasureValue (MEDIAN)
MSB0010841 30 mgTime to Maximum Observed Concentration (Tmax) Post Second Dose of MSB001084184.2 hour
MSB0010841 60 mgTime to Maximum Observed Concentration (Tmax) Post Second Dose of MSB001084172.0 hour
MSB0010841 120 mgTime to Maximum Observed Concentration (Tmax) Post Second Dose of MSB001084183.4 hour
MSB0010841 240 mgTime to Maximum Observed Concentration (Tmax) Post Second Dose of MSB001084172.0 hour
Primary

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.

ArmMeasureValue (MEDIAN)
MSB0010841 30 mgTime to Reach Maximum Observed Concentration (Tmax) Post First Dose of MSB001084172.39 hour
MSB0010841 60 mgTime to Reach Maximum Observed Concentration (Tmax) Post First Dose of MSB001084171.68 hour
MSB0010841 120 mgTime to Reach Maximum Observed Concentration (Tmax) Post First Dose of MSB001084152.00 hour
MSB0010841 240 mgTime to Reach Maximum Observed Concentration (Tmax) Post First Dose of MSB001084172.23 hour
Primary

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.

ArmMeasureValue (MEDIAN)
MSB0010841 30 mgTime to Reach Maximum Observed Concentration (Tmax) Post Third Dose of MSB001084131.5 hour
MSB0010841 60 mgTime to Reach Maximum Observed Concentration (Tmax) Post Third Dose of MSB001084131.0 hour
MSB0010841 120 mgTime to Reach Maximum Observed Concentration (Tmax) Post Third Dose of MSB001084172.0 hour
MSB0010841 240 mgTime to Reach Maximum Observed Concentration (Tmax) Post Third Dose of MSB001084172.0 hour
Secondary

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).

ArmMeasureGroupValue (MEAN)Dispersion
MSB0010841 30 mgMean Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Day 43Baseline16.91 units on a scaleStandard Deviation 5.75
MSB0010841 30 mgMean Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Day 43Change at Day 43-13.93 units on a scaleStandard Deviation 4.76
MSB0010841 60 mgMean Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Day 43Baseline19.76 units on a scaleStandard Deviation 4.79
MSB0010841 60 mgMean Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Day 43Change at Day 43-17.99 units on a scaleStandard Deviation 5.52
MSB0010841 120 mgMean Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Day 43Baseline23.35 units on a scaleStandard Deviation 6.6
MSB0010841 120 mgMean Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Day 43Change at Day 43-21.70 units on a scaleStandard Deviation 8.52
MSB0010841 240 mgMean Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Day 43Change at Day 43-16.68 units on a scaleStandard Deviation 8.38
MSB0010841 240 mgMean Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Day 43Baseline18.38 units on a scaleStandard Deviation 6.07
PlaceboMean Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Day 43Baseline25.49 units on a scaleStandard Deviation 5.58
PlaceboMean Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Day 43Change at Day 43-5.43 units on a scaleStandard Deviation 7.04
Secondary

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.

ArmMeasureGroupValue (MEAN)Dispersion
MSB0010841 30 mgMean Percent Change From Baseline in the Body Surface Area (BSA) Affected by Psoriasis at Day 8, 15, 22, 29, 36, 43, 50 and 85Change at Day 43 (8,8,8,9,8)-52.6 percent changeStandard Deviation 32.91
MSB0010841 30 mgMean Percent Change From Baseline in the Body Surface Area (BSA) Affected by Psoriasis at Day 8, 15, 22, 29, 36, 43, 50 and 85Change at Day 22 (n=8,8,8,8,8)-11.6 percent changeStandard Deviation 24.9
MSB0010841 30 mgMean Percent Change From Baseline in the Body Surface Area (BSA) Affected by Psoriasis at Day 8, 15, 22, 29, 36, 43, 50 and 85Change at Day 8 (n=8,8,8,8,8)0.4 percent changeStandard Deviation 1.14
MSB0010841 30 mgMean Percent Change From Baseline in the Body Surface Area (BSA) Affected by Psoriasis at Day 8, 15, 22, 29, 36, 43, 50 and 85Change at Day 85 (8,8,8,9,8)-60.4 percent changeStandard Deviation 33.51
MSB0010841 30 mgMean Percent Change From Baseline in the Body Surface Area (BSA) Affected by Psoriasis at Day 8, 15, 22, 29, 36, 43, 50 and 85Change at Day 36 (8,8,7,7,7)-31.4 percent changeStandard Deviation 22.96
MSB0010841 30 mgMean Percent Change From Baseline in the Body Surface Area (BSA) Affected by Psoriasis at Day 8, 15, 22, 29, 36, 43, 50 and 85Change at Day 29 (n=8,8,8,8,8)-22.6 percent changeStandard Deviation 26.35
MSB0010841 30 mgMean Percent Change From Baseline in the Body Surface Area (BSA) Affected by Psoriasis at Day 8, 15, 22, 29, 36, 43, 50 and 85Change at Day 50 (n=8,8,8,9,8)-56.2 percent changeStandard Deviation 34.71
MSB0010841 30 mgMean Percent Change From Baseline in the Body Surface Area (BSA) Affected by Psoriasis at Day 8, 15, 22, 29, 36, 43, 50 and 85Change at Day 15 (n=8,8,8,8,8)0.4 percent changeStandard Deviation 1.14
MSB0010841 60 mgMean Percent Change From Baseline in the Body Surface Area (BSA) Affected by Psoriasis at Day 8, 15, 22, 29, 36, 43, 50 and 85Change at Day 36 (8,8,7,7,7)-52.7 percent changeStandard Deviation 37.57
MSB0010841 60 mgMean Percent Change From Baseline in the Body Surface Area (BSA) Affected by Psoriasis at Day 8, 15, 22, 29, 36, 43, 50 and 85Change at Day 43 (8,8,8,9,8)-65.2 percent changeStandard Deviation 28.61
MSB0010841 60 mgMean Percent Change From Baseline in the Body Surface Area (BSA) Affected by Psoriasis at Day 8, 15, 22, 29, 36, 43, 50 and 85Change at Day 85 (8,8,8,9,8)-61.3 percent changeStandard Deviation 33.89
MSB0010841 60 mgMean Percent Change From Baseline in the Body Surface Area (BSA) Affected by Psoriasis at Day 8, 15, 22, 29, 36, 43, 50 and 85Change at Day 15 (n=8,8,8,8,8)-33.1 percent changeStandard Deviation 35.97
MSB0010841 60 mgMean Percent Change From Baseline in the Body Surface Area (BSA) Affected by Psoriasis at Day 8, 15, 22, 29, 36, 43, 50 and 85Change at Day 22 (n=8,8,8,8,8)-40.2 percent changeStandard Deviation 40.68
MSB0010841 60 mgMean Percent Change From Baseline in the Body Surface Area (BSA) Affected by Psoriasis at Day 8, 15, 22, 29, 36, 43, 50 and 85Change at Day 8 (n=8,8,8,8,8)-30.0 percent changeStandard Deviation 31.23
MSB0010841 60 mgMean Percent Change From Baseline in the Body Surface Area (BSA) Affected by Psoriasis at Day 8, 15, 22, 29, 36, 43, 50 and 85Change at Day 29 (n=8,8,8,8,8)-44.1 percent changeStandard Deviation 42.53
MSB0010841 60 mgMean Percent Change From Baseline in the Body Surface Area (BSA) Affected by Psoriasis at Day 8, 15, 22, 29, 36, 43, 50 and 85Change at Day 50 (n=8,8,8,9,8)-69.4 percent changeStandard Deviation 25.85
MSB0010841 120 mgMean Percent Change From Baseline in the Body Surface Area (BSA) Affected by Psoriasis at Day 8, 15, 22, 29, 36, 43, 50 and 85Change at Day 50 (n=8,8,8,9,8)-79.1 percent changeStandard Deviation 32.3
MSB0010841 120 mgMean Percent Change From Baseline in the Body Surface Area (BSA) Affected by Psoriasis at Day 8, 15, 22, 29, 36, 43, 50 and 85Change at Day 43 (8,8,8,9,8)-75.4 percent changeStandard Deviation 37.35
MSB0010841 120 mgMean Percent Change From Baseline in the Body Surface Area (BSA) Affected by Psoriasis at Day 8, 15, 22, 29, 36, 43, 50 and 85Change at Day 85 (8,8,8,9,8)-82.1 percent changeStandard Deviation 31.05
MSB0010841 120 mgMean Percent Change From Baseline in the Body Surface Area (BSA) Affected by Psoriasis at Day 8, 15, 22, 29, 36, 43, 50 and 85Change at Day 29 (n=8,8,8,8,8)-55.9 percent changeStandard Deviation 36.56
MSB0010841 120 mgMean Percent Change From Baseline in the Body Surface Area (BSA) Affected by Psoriasis at Day 8, 15, 22, 29, 36, 43, 50 and 85Change at Day 15 (n=8,8,8,8,8)-20.5 percent changeStandard Deviation 10.98
MSB0010841 120 mgMean Percent Change From Baseline in the Body Surface Area (BSA) Affected by Psoriasis at Day 8, 15, 22, 29, 36, 43, 50 and 85Change at Day 8 (n=8,8,8,8,8)-13.7 percent changeStandard Deviation 15.13
MSB0010841 120 mgMean Percent Change From Baseline in the Body Surface Area (BSA) Affected by Psoriasis at Day 8, 15, 22, 29, 36, 43, 50 and 85Change at Day 22 (n=8,8,8,8,8)-42.6 percent changeStandard Deviation 27.15
MSB0010841 120 mgMean Percent Change From Baseline in the Body Surface Area (BSA) Affected by Psoriasis at Day 8, 15, 22, 29, 36, 43, 50 and 85Change at Day 36 (8,8,7,7,7)-64.6 percent changeStandard Deviation 37.65
MSB0010841 240 mgMean Percent Change From Baseline in the Body Surface Area (BSA) Affected by Psoriasis at Day 8, 15, 22, 29, 36, 43, 50 and 85Change at Day 50 (n=8,8,8,9,8)-82.2 percent changeStandard Deviation 36.64
MSB0010841 240 mgMean Percent Change From Baseline in the Body Surface Area (BSA) Affected by Psoriasis at Day 8, 15, 22, 29, 36, 43, 50 and 85Change at Day 8 (n=8,8,8,8,8)-12.5 percent changeStandard Deviation 23.81
MSB0010841 240 mgMean Percent Change From Baseline in the Body Surface Area (BSA) Affected by Psoriasis at Day 8, 15, 22, 29, 36, 43, 50 and 85Change at Day 15 (n=8,8,8,8,8)-51.1 percent changeStandard Deviation 43.17
MSB0010841 240 mgMean Percent Change From Baseline in the Body Surface Area (BSA) Affected by Psoriasis at Day 8, 15, 22, 29, 36, 43, 50 and 85Change at Day 22 (n=8,8,8,8,8)-68.5 percent changeStandard Deviation 38.71
MSB0010841 240 mgMean Percent Change From Baseline in the Body Surface Area (BSA) Affected by Psoriasis at Day 8, 15, 22, 29, 36, 43, 50 and 85Change at Day 29 (n=8,8,8,8,8)-82.9 percent changeStandard Deviation 34.46
MSB0010841 240 mgMean Percent Change From Baseline in the Body Surface Area (BSA) Affected by Psoriasis at Day 8, 15, 22, 29, 36, 43, 50 and 85Change at Day 36 (8,8,7,7,7)-83.5 percent changeStandard Deviation 31.6
MSB0010841 240 mgMean Percent Change From Baseline in the Body Surface Area (BSA) Affected by Psoriasis at Day 8, 15, 22, 29, 36, 43, 50 and 85Change at Day 43 (8,8,8,9,8)-82.2 percent changeStandard Deviation 36.64
MSB0010841 240 mgMean Percent Change From Baseline in the Body Surface Area (BSA) Affected by Psoriasis at Day 8, 15, 22, 29, 36, 43, 50 and 85Change at Day 85 (8,8,8,9,8)-95.5 percent changeStandard Deviation 11.02
PlaceboMean Percent Change From Baseline in the Body Surface Area (BSA) Affected by Psoriasis at Day 8, 15, 22, 29, 36, 43, 50 and 85Change at Day 36 (8,8,7,7,7)-0.5 percent changeStandard Deviation 27.92
PlaceboMean Percent Change From Baseline in the Body Surface Area (BSA) Affected by Psoriasis at Day 8, 15, 22, 29, 36, 43, 50 and 85Change at Day 29 (n=8,8,8,8,8)-0.1 percent changeStandard Deviation 26.13
PlaceboMean Percent Change From Baseline in the Body Surface Area (BSA) Affected by Psoriasis at Day 8, 15, 22, 29, 36, 43, 50 and 85Change at Day 22 (n=8,8,8,8,8)-5.1 percent changeStandard Deviation 12.69
PlaceboMean Percent Change From Baseline in the Body Surface Area (BSA) Affected by Psoriasis at Day 8, 15, 22, 29, 36, 43, 50 and 85Change at Day 15 (n=8,8,8,8,8)-4.2 percent changeStandard Deviation 12.21
PlaceboMean Percent Change From Baseline in the Body Surface Area (BSA) Affected by Psoriasis at Day 8, 15, 22, 29, 36, 43, 50 and 85Change at Day 8 (n=8,8,8,8,8)2.9 percent changeStandard Deviation 23.32
PlaceboMean Percent Change From Baseline in the Body Surface Area (BSA) Affected by Psoriasis at Day 8, 15, 22, 29, 36, 43, 50 and 85Change at Day 50 (n=8,8,8,9,8)-10.0 percent changeStandard Deviation 17.87
PlaceboMean Percent Change From Baseline in the Body Surface Area (BSA) Affected by Psoriasis at Day 8, 15, 22, 29, 36, 43, 50 and 85Change at Day 85 (8,8,8,9,8)-13.0 percent changeStandard Deviation 20.13
PlaceboMean Percent Change From Baseline in the Body Surface Area (BSA) Affected by Psoriasis at Day 8, 15, 22, 29, 36, 43, 50 and 85Change at Day 43 (8,8,8,9,8)-1.5 percent changeStandard Deviation 27.05
Secondary

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).

ArmMeasureGroupValue (NUMBER)
MSB0010841 30 mgPercentage of Subjects With 50% or 75% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) ScorePASI-50100 percentage of subjects
MSB0010841 30 mgPercentage of Subjects With 50% or 75% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) ScorePASI-7588 percentage of subjects
MSB0010841 60 mgPercentage of Subjects With 50% or 75% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) ScorePASI-75100 percentage of subjects
MSB0010841 60 mgPercentage of Subjects With 50% or 75% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) ScorePASI-50100 percentage of subjects
MSB0010841 120 mgPercentage of Subjects With 50% or 75% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) ScorePASI-75100 percentage of subjects
MSB0010841 120 mgPercentage of Subjects With 50% or 75% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) ScorePASI-50100 percentage of subjects
MSB0010841 240 mgPercentage of Subjects With 50% or 75% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) ScorePASI-50100 percentage of subjects
MSB0010841 240 mgPercentage of Subjects With 50% or 75% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) ScorePASI-75100 percentage of subjects
PlaceboPercentage of Subjects With 50% or 75% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) ScorePASI-750 percentage of subjects
PlaceboPercentage of Subjects With 50% or 75% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) ScorePASI-5050 percentage of subjects
Secondary

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).

ArmMeasureValue (NUMBER)
MSB0010841 30 mgPercentage of Subjects With Exacerbation of Psoriasis0 percentage of subjects
MSB0010841 60 mgPercentage of Subjects With Exacerbation of Psoriasis0 percentage of subjects
MSB0010841 120 mgPercentage of Subjects With Exacerbation of Psoriasis0 percentage of subjects
MSB0010841 240 mgPercentage of Subjects With Exacerbation of Psoriasis0 percentage of subjects
PlaceboPercentage of Subjects With Exacerbation of Psoriasis12.5 percentage of subjects
Secondary

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).

ArmMeasureGroupValue (NUMBER)
MSB0010841 30 mgPercentage of Subjects With Static Physician's Global Assessment (sPGA) Score of Minimal or Clear and With at Least 2 Level Reduction From BaselineDay 1525 percentage of subjects
MSB0010841 30 mgPercentage of Subjects With Static Physician's Global Assessment (sPGA) Score of Minimal or Clear and With at Least 2 Level Reduction From BaselineDay 80 percentage of subjects
MSB0010841 30 mgPercentage of Subjects With Static Physician's Global Assessment (sPGA) Score of Minimal or Clear and With at Least 2 Level Reduction From BaselineDay 2250 percentage of subjects
MSB0010841 30 mgPercentage of Subjects With Static Physician's Global Assessment (sPGA) Score of Minimal or Clear and With at Least 2 Level Reduction From BaselineDay 8588 percentage of subjects
MSB0010841 30 mgPercentage of Subjects With Static Physician's Global Assessment (sPGA) Score of Minimal or Clear and With at Least 2 Level Reduction From BaselineDay 5075 percentage of subjects
MSB0010841 30 mgPercentage of Subjects With Static Physician's Global Assessment (sPGA) Score of Minimal or Clear and With at Least 2 Level Reduction From BaselineDay 3663 percentage of subjects
MSB0010841 30 mgPercentage of Subjects With Static Physician's Global Assessment (sPGA) Score of Minimal or Clear and With at Least 2 Level Reduction From BaselineDay 2963 percentage of subjects
MSB0010841 30 mgPercentage of Subjects With Static Physician's Global Assessment (sPGA) Score of Minimal or Clear and With at Least 2 Level Reduction From BaselineDay 4375 percentage of subjects
MSB0010841 60 mgPercentage of Subjects With Static Physician's Global Assessment (sPGA) Score of Minimal or Clear and With at Least 2 Level Reduction From BaselineDay 5088 percentage of subjects
MSB0010841 60 mgPercentage of Subjects With Static Physician's Global Assessment (sPGA) Score of Minimal or Clear and With at Least 2 Level Reduction From BaselineDay 8588 percentage of subjects
MSB0010841 60 mgPercentage of Subjects With Static Physician's Global Assessment (sPGA) Score of Minimal or Clear and With at Least 2 Level Reduction From BaselineDay 1525 percentage of subjects
MSB0010841 60 mgPercentage of Subjects With Static Physician's Global Assessment (sPGA) Score of Minimal or Clear and With at Least 2 Level Reduction From BaselineDay 2250 percentage of subjects
MSB0010841 60 mgPercentage of Subjects With Static Physician's Global Assessment (sPGA) Score of Minimal or Clear and With at Least 2 Level Reduction From BaselineDay 2963 percentage of subjects
MSB0010841 60 mgPercentage of Subjects With Static Physician's Global Assessment (sPGA) Score of Minimal or Clear and With at Least 2 Level Reduction From BaselineDay 3688 percentage of subjects
MSB0010841 60 mgPercentage of Subjects With Static Physician's Global Assessment (sPGA) Score of Minimal or Clear and With at Least 2 Level Reduction From BaselineDay 4388 percentage of subjects
MSB0010841 60 mgPercentage of Subjects With Static Physician's Global Assessment (sPGA) Score of Minimal or Clear and With at Least 2 Level Reduction From BaselineDay 838 percentage of subjects
MSB0010841 120 mgPercentage of Subjects With Static Physician's Global Assessment (sPGA) Score of Minimal or Clear and With at Least 2 Level Reduction From BaselineDay 3675 percentage of subjects
MSB0010841 120 mgPercentage of Subjects With Static Physician's Global Assessment (sPGA) Score of Minimal or Clear and With at Least 2 Level Reduction From BaselineDay 4375 percentage of subjects
MSB0010841 120 mgPercentage of Subjects With Static Physician's Global Assessment (sPGA) Score of Minimal or Clear and With at Least 2 Level Reduction From BaselineDay 813 percentage of subjects
MSB0010841 120 mgPercentage of Subjects With Static Physician's Global Assessment (sPGA) Score of Minimal or Clear and With at Least 2 Level Reduction From BaselineDay 2988 percentage of subjects
MSB0010841 120 mgPercentage of Subjects With Static Physician's Global Assessment (sPGA) Score of Minimal or Clear and With at Least 2 Level Reduction From BaselineDay 2250 percentage of subjects
MSB0010841 120 mgPercentage of Subjects With Static Physician's Global Assessment (sPGA) Score of Minimal or Clear and With at Least 2 Level Reduction From BaselineDay 1513 percentage of subjects
MSB0010841 120 mgPercentage of Subjects With Static Physician's Global Assessment (sPGA) Score of Minimal or Clear and With at Least 2 Level Reduction From BaselineDay 8588 percentage of subjects
MSB0010841 120 mgPercentage of Subjects With Static Physician's Global Assessment (sPGA) Score of Minimal or Clear and With at Least 2 Level Reduction From BaselineDay 50100 percentage of subjects
MSB0010841 240 mgPercentage of Subjects With Static Physician's Global Assessment (sPGA) Score of Minimal or Clear and With at Least 2 Level Reduction From BaselineDay 2267 percentage of subjects
MSB0010841 240 mgPercentage of Subjects With Static Physician's Global Assessment (sPGA) Score of Minimal or Clear and With at Least 2 Level Reduction From BaselineDay 85100 percentage of subjects
MSB0010841 240 mgPercentage of Subjects With Static Physician's Global Assessment (sPGA) Score of Minimal or Clear and With at Least 2 Level Reduction From BaselineDay 2978 percentage of subjects
MSB0010841 240 mgPercentage of Subjects With Static Physician's Global Assessment (sPGA) Score of Minimal or Clear and With at Least 2 Level Reduction From BaselineDay 4367 percentage of subjects
MSB0010841 240 mgPercentage of Subjects With Static Physician's Global Assessment (sPGA) Score of Minimal or Clear and With at Least 2 Level Reduction From BaselineDay 3667 percentage of subjects
MSB0010841 240 mgPercentage of Subjects With Static Physician's Global Assessment (sPGA) Score of Minimal or Clear and With at Least 2 Level Reduction From BaselineDay 1556 percentage of subjects
MSB0010841 240 mgPercentage of Subjects With Static Physician's Global Assessment (sPGA) Score of Minimal or Clear and With at Least 2 Level Reduction From BaselineDay 5089 percentage of subjects
MSB0010841 240 mgPercentage of Subjects With Static Physician's Global Assessment (sPGA) Score of Minimal or Clear and With at Least 2 Level Reduction From BaselineDay 811 percentage of subjects
PlaceboPercentage of Subjects With Static Physician's Global Assessment (sPGA) Score of Minimal or Clear and With at Least 2 Level Reduction From BaselineDay 850 percentage of subjects
PlaceboPercentage of Subjects With Static Physician's Global Assessment (sPGA) Score of Minimal or Clear and With at Least 2 Level Reduction From BaselineDay 150 percentage of subjects
PlaceboPercentage of Subjects With Static Physician's Global Assessment (sPGA) Score of Minimal or Clear and With at Least 2 Level Reduction From BaselineDay 220 percentage of subjects
PlaceboPercentage of Subjects With Static Physician's Global Assessment (sPGA) Score of Minimal or Clear and With at Least 2 Level Reduction From BaselineDay 290 percentage of subjects
PlaceboPercentage of Subjects With Static Physician's Global Assessment (sPGA) Score of Minimal or Clear and With at Least 2 Level Reduction From BaselineDay 360 percentage of subjects
PlaceboPercentage of Subjects With Static Physician's Global Assessment (sPGA) Score of Minimal or Clear and With at Least 2 Level Reduction From BaselineDay 430 percentage of subjects
PlaceboPercentage of Subjects With Static Physician's Global Assessment (sPGA) Score of Minimal or Clear and With at Least 2 Level Reduction From BaselineDay 500 percentage of subjects
PlaceboPercentage of Subjects With Static Physician's Global Assessment (sPGA) Score of Minimal or Clear and With at Least 2 Level Reduction From BaselineDay 80 percentage of subjects

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026