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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-005436-18 | EudraCT Number |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MSB0010841 30 mg | Experimental |
| |
| MSB0010841 60 mg | Experimental |
| |
| MSB0010841 120 mg | Experimental |
| |
| MSB0010841 240 mg | Experimental |
| |
| Placebo | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MSB0010841 | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline up to Day 85 |
| 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. | Day 1, 2,8, 15, 16, 22, 29, 30, 36, 43 |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Responsible | Merck KGaA, Darmstadt, Germany | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Please contact the Merck KGaA Communication Center | Darmstadt | Germany |
A total of 41 subjects were randomized in the trial and included in the Safety analysis set.
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| ID | Title | Description |
|---|---|---|
| FG000 | MSB0010841 30 mg | MSB0010841 (Anti-Interleukin [IL]-17A/F Nanobody) was administered at a dose of 30 milligram (mg) as subcutaneous (SC) injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks. |
| FG001 | 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. |
| FG002 | 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. |
| FG003 | 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. |
| FG004 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Safety analysis set included all 41 subjects who received at least 1 dose of investigational medicinal product (IMP) (MSB0010841 or placebo).
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | MSB0010841 60 mg |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Safety analysis set included all 41 subjects who received at least 1 dose of IMP (MSB0010841 or placebo). | Posted | Number | subjects | Baseline up to Day 85 |
|
Baseline up to Day 85
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute vestibular syndrome | Ear and labyrinth disorders | MedDRA 18.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Leukopenia | Blood and lymphatic system disorders | MedDRA 18.0 | Non-systematic Assessment |
As AUCextra was more than 20% of AUC0-inf after first dose, AUCextra and all values derived from λz were regarded as implausible and "AUC0-inf", "MRT0-inf", "t1/2", "λz", "CL/f", and "Vz/f" were not calculated after first dose.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Merck KGaA Communication Center | Merck Healthcare, a business of Merck KGaA, Darmstadt, Germany | +49-6151-72-5200 | service@merckgroup.com |
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| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| MSB0010841 | Drug | MSB0010841 will be 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. |
|
|
| MSB0010841 | Drug | MSB0010841 will be 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. |
|
|
| MSB0010841 | Drug | MSB0010841 will be 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. |
|
|
| Placebo | Drug | 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. |
|
| Day 1, 2, 8, 15, 16, 22, 29, 30, 36, 43 |
| Percentage of Subjects With Anti-MSB0010841 Binding Antibodies (Anti-Drug Antibodies [ADA]) | Data were presented for MSB0010841 combined group and placebo. | Baseline up to Day 85 |
| Levels of Anti-MSB0010841 Antibody Titers | Day 8, 15 (pre-dose), 22, 29 (pre-dose), 36, 43, 63 and 85 |
| Levels of Pre-existing Anti-MSB0010841 Antibody Titers | Pre-dose on Day 1 |
| MSB0010841 Serum Concentration Over Time After First Dose | 0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336 hours post-first dose (Day 1) |
| MSB0010841 Serum Concentration Over Time After Second Dose | 0 hours (pre-dose), 24, 72, 96, 168, 336 hours post-second dose (Day 15) |
| MSB0010841 Serum Concentration Over Time After Third Dose | 0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336, 504, 816, 1056, 1344 hours post-third dose (Day 29) |
| Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUC0-t) Post First Dose of MSB0010841 | 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). | 0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336 hours post-first dose (Day 1) |
| 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. | 0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336, 504, 816, 1056, 1344 hours post-third dose (Day 29) |
| Area Under the 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). | 0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336 hours post-first dose (Day 1) |
| Area Under the Concentration-Time Curve From Time Zero up to Time Tau (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). | 0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336 hours post-third dose (Day 29) |
| Area Under the Concentration-time Curve From Time Zero 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. | 0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336, 504, 816, 1056, 1344 hours post-third dose (Day 29) |
| Observed Serum Concentration Immediately Before First Dose (Cpre) of MSB0010841 | The observed serum concentration immediately before the first dose. | Pre-dose (0 hours) on Day 1 |
| Observed Serum Concentration Immediately Before Third Dose (Cpre) of MSB0010841 | The observed serum concentration immediately before the third dose. | Pre-dose (0 hours) on Day 29 |
| 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. | 0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336 hours post-first dose (Day 1) |
| 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. | 0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336, 504, 816, 1056, 1344 hours post-third dose (Day 29) |
| Maximum Concentration Observed (Cmax) Post First Dose of MSB0010841 | 0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336 hours post-first dose (Day 1) |
| Maximum Concentration Observed (Cmax) Post Third Dose of MSB0010841 | 0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336, 504, 816, 1056, 1344 hours post-third dose (Day 29) |
| Average Concentration (Cav) Post First Dose of MSB0010841 | Cav was calculated by AUCtau/tau. Where tau is the dosing interval (336 hours). | 0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336 hours post-first dose (Day 1) |
| Average Concentration (Cav) Post Third Dose of MSB0010841 | Cav was calculated by AUCtau/tau. Where tau is the dosing interval (336 hours). | 0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336, 504, 816, 1056, 1344 hours post-third dose (Day 29) |
| Mean Residence Time (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). | 0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336 hours post-first dose (Day 1) |
| 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). | 0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336 hours post-third dose (Day 29) |
| 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. | 0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336, 504, 816, 1056, 1344 hours post-third dose (Day 29) |
| Time to Reach Maximum Observed Concentration (Tmax) Post First Dose of MSB0010841 | 0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336 hours post-first dose (Day 1) |
| Time to Maximum Observed Concentration (Tmax) Post Second Dose of MSB0010841 | 0 hours (pre-dose), 24, 72, 96, 168, 336 hours post-second dose (Day 15) |
| Time to Reach Maximum Observed Concentration (Tmax) Post Third Dose of MSB0010841 | 0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336, 504, 816, 1056, 1344 hours post-third dose (Day 29) |
| Apparent Terminal Half-life (t1/2) Post Third Dose of MSB0010841 | 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. | 0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336, 504, 816, 1056, 1344 hours post-third dose (Day 29) |
| Terminal Rate Constant (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 | 0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336, 504, 816, 1056, 1344 hours post-third dose (Day 29) |
| 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. | 0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336, 504, 816, 1056, 1344 hours post-third dose (Day 29) |
| 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. | 0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336, 504, 816, 1056, 1344 hours post-third dose (Day 29) |
| 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 | 0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336 hours post-first dose (Day 1) |
| 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 | 0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336, 504, 816, 1056, 1344 hours post-third dose (Day 29) |
| Accumulation Ratio of Cmax (Racc (Cmax)) | Accumulation ratio for Cmax was calculated as Cmax, after third dose / Cmax, after first dose. | 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 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. | 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) |
| Maximum Observed Concentration (Cmax) Post Second Dose of MSB0010841 | 0 hours (pre-dose), 24, 72, 96, 168, 336 hours post-second dose (Day 15) |
| Observed Serum Concentration Immediately Before Second Dose (Cpre) of MSB0010841 | The observed serum concentration immediately before second dose. | Pre-dose (0 hours) on Day 15 |
| Baseline up to Day 85 |
| 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. | Baseline, Day 43 |
| 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. | Day 8, 15, 22, 29, 36, 43, 50, 85 |
| 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. | Baseline, Day 8, 15, 22, 29, 36, 43, 50 and 85 |
| 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). | Baseline up to Day 85 |
| Quantiferon Positivity |
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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.
| BG002 | 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. |
| BG003 | 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. |
| BG004 | 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. |
| BG005 | Total | Total of all reporting groups |
| years |
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| Gender | Count of Participants | Participants |
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| OG001 | 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. |
| OG002 | 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. |
| OG003 | 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. |
| OG004 | 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. |
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| 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. | 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. | Posted | Number | subjects | Day 1, 2,8, 15, 16, 22, 29, 30, 36, 43 |
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| 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. | 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. | Posted | Number | mm | Day 1, 2, 8, 15, 16, 22, 29, 30, 36, 43 |
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| Primary | Percentage of Subjects With Anti-MSB0010841 Binding Antibodies (Anti-Drug Antibodies [ADA]) | Data were presented for MSB0010841 combined group and placebo. | Safety analysis set included all 41 subjects who received at least one dose of IMP (MSB0010841 or placebo). | Posted | Number | percentage of subjects | Baseline up to Day 85 |
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| Primary | Levels of Anti-MSB0010841 Antibody Titers | 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. | Posted | Number | log10titer | Day 8, 15 (pre-dose), 22, 29 (pre-dose), 36, 43, 63 and 85 |
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| Primary | Levels of Pre-existing Anti-MSB0010841 Antibody Titers | 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. | Posted | Number | log10titer | Pre-dose on Day 1 |
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| Primary | MSB0010841 Serum Concentration Over Time After First Dose | 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. | Posted | Mean | Standard Deviation | nanogram/milliliter (ng/mL) | 0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336 hours post-first dose (Day 1) |
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| Primary | MSB0010841 Serum Concentration Over Time After Second Dose | 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. | Posted | Mean | Standard Deviation | ng/mL | 0 hours (pre-dose), 24, 72, 96, 168, 336 hours post-second dose (Day 15) |
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| Primary | MSB0010841 Serum Concentration Over Time After Third Dose | 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. | Posted | Mean | Standard Deviation | ng/mL | 0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336, 504, 816, 1056, 1344 hours post-third dose (Day 29) |
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| 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). | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | day*microgram per milliliter (day*mcg/mL | 0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336 hours post-first dose (Day 1) |
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| 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. | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | day*mcg/mL | 0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336, 504, 816, 1056, 1344 hours post-third dose (Day 29) |
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| 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). | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | day*mcg/mL | 0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336 hours post-first dose (Day 1) |
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| 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). | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | day*mcg/mL | 0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336 hours post-third dose (Day 29) |
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| 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. | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | day*ug/mL | 0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336, 504, 816, 1056, 1344 hours post-third dose (Day 29) |
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| Primary | Observed Serum Concentration Immediately Before First Dose (Cpre) of MSB0010841 | The observed serum concentration immediately before the first dose. | 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. | Posted | Mean | Standard Deviation | mcg/mL | Pre-dose (0 hours) on Day 1 |
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| Primary | Observed Serum Concentration Immediately Before Third Dose (Cpre) of MSB0010841 | The observed serum concentration immediately before the third dose. | 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. | Posted | Mean | Standard Deviation | mcg/mL | Pre-dose (0 hours) on Day 29 |
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| 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. | 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. | Posted | Mean | Standard Deviation | mcg/mL | 0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336 hours post-first dose (Day 1) |
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| 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. | 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. | Posted | Mean | Standard Deviation | mcg/mL | 0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336, 504, 816, 1056, 1344 hours post-third dose (Day 29) |
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| Primary | Maximum Concentration Observed (Cmax) Post First Dose of MSB0010841 | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | mcg/mL | 0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336 hours post-first dose (Day 1) |
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| Primary | Maximum Concentration Observed (Cmax) Post Third Dose of MSB0010841 | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | mcg/mL | 0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336, 504, 816, 1056, 1344 hours post-third dose (Day 29) |
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| Primary | Average Concentration (Cav) Post First Dose of MSB0010841 | Cav was calculated by AUCtau/tau. Where tau is the dosing interval (336 hours). | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | mcg/mL | 0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336 hours post-first dose (Day 1) |
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| Primary | Average Concentration (Cav) Post Third Dose of MSB0010841 | Cav was calculated by AUCtau/tau. Where tau is the dosing interval (336 hours). | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | mcg/mL | 0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336, 504, 816, 1056, 1344 hours post-third dose (Day 29) |
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| 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). | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | day | 0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336 hours post-first dose (Day 1) |
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| 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). | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | day | 0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336 hours post-third dose (Day 29) |
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| 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. | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | day | 0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336, 504, 816, 1056, 1344 hours post-third dose (Day 29) |
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| Primary | Time to Reach Maximum Observed Concentration (Tmax) Post First Dose of MSB0010841 | 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. | Posted | Median | Full Range | hour | 0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336 hours post-first dose (Day 1) |
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| Primary | Time to Maximum Observed Concentration (Tmax) Post Second Dose of MSB0010841 | 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. | Posted | Median | Full Range | hour | 0 hours (pre-dose), 24, 72, 96, 168, 336 hours post-second dose (Day 15) |
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| Primary | Time to Reach Maximum Observed Concentration (Tmax) Post Third Dose of MSB0010841 | 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. | Posted | Median | Full Range | hour | 0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336, 504, 816, 1056, 1344 hours post-third dose (Day 29) |
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| 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. | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | day | 0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336, 504, 816, 1056, 1344 hours post-third dose (Day 29) |
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| 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 | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | 1/hour | 0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336, 504, 816, 1056, 1344 hours post-third dose (Day 29) |
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| 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. | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | L/day | 0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336, 504, 816, 1056, 1344 hours post-third dose (Day 29) |
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| 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. | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | Liters | 0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336, 504, 816, 1056, 1344 hours post-third dose (Day 29) |
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| 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 | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | percentage fluctuation | 0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336 hours post-first dose (Day 1) |
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| 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 | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | percentage fluctuation | 0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336, 504, 816, 1056, 1344 hours post-third dose (Day 29) |
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| Primary | Accumulation Ratio of Cmax (Racc (Cmax)) | Accumulation ratio for Cmax was calculated as Cmax, after third dose / Cmax, after first dose. | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | ratio | 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) |
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| 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. | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | ratio | 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) |
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| Primary | Maximum Observed Concentration (Cmax) Post Second Dose of MSB0010841 | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | mcg/mL | 0 hours (pre-dose), 24, 72, 96, 168, 336 hours post-second dose (Day 15) |
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| Primary | Observed Serum Concentration Immediately Before Second Dose (Cpre) of MSB0010841 | The observed serum concentration immediately before second dose. | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | mcg/mL | Pre-dose (0 hours) on Day 15 |
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| 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. | Safety analysis set included all 41 subjects who received at least 1 dose of IMP (MSB0010841 or placebo). | Posted | Number | percentage of subjects | Baseline up to Day 85 |
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| 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. | Safety analysis set included all 41 subjects who received at least one dose of IMP (MSB0010841 or placebo). | Posted | Mean | Standard Deviation | units on a scale | Baseline, Day 43 |
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| 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. | Safety analysis set included all 41 subjects who received at least one dose of IMP (MSB0010841 or placebo). | Posted | Number | percentage of subjects | Day 8, 15, 22, 29, 36, 43, 50, 85 |
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| 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. | 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. | Posted | Mean | Standard Deviation | percent change | Baseline, Day 8, 15, 22, 29, 36, 43, 50 and 85 |
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| 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). | Safety analysis set included all 41 subjects who received at least 1 dose of IMP (MSB0010841 or placebo). | Posted | Number | percentage of subjects | Baseline up to Day 85 |
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| 1 |
| 8 |
| 5 |
| 8 |
| EG001 | 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. | 0 | 8 | 5 | 8 |
| EG002 | 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. | 0 | 8 | 5 | 8 |
| EG003 | 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. | 0 | 9 | 6 | 9 |
| EG004 | 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. | 0 | 8 | 6 | 8 |
| Lacrimation increased | Eye disorders | MedDRA 18.0 | Non-systematic Assessment |
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| Hypoaesthesia oral | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
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| Toothache | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
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| Asthenia | General disorders | MedDRA 18.0 | Non-systematic Assessment |
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| Influenza like illness | General disorders | MedDRA 18.0 | Non-systematic Assessment |
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| Injection site erythema | General disorders | MedDRA 18.0 | Non-systematic Assessment |
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| Injection site reaction | General disorders | MedDRA 18.0 | Non-systematic Assessment |
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| Injection site swelling | General disorders | MedDRA 18.0 | Non-systematic Assessment |
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| Injection site urticaria | General disorders | MedDRA 18.0 | Non-systematic Assessment |
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| Fatigue | General disorders | MedDRA 18.0 | Non-systematic Assessment |
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| Peripheral swelling | General disorders | MedDRA 18.0 | Non-systematic Assessment |
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| Biliary colic | Hepatobiliary disorders | MedDRA 18.0 | Non-systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
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| Bacterial vaginosis | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
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| Cystitis | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
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| Otitis media | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
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| Paronychia | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | MedDRA 18.0 | Non-systematic Assessment |
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| Limb injury | Injury, poisoning and procedural complications | MedDRA 18.0 | Non-systematic Assessment |
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| Sunburn | Injury, poisoning and procedural complications | MedDRA 18.0 | Non-systematic Assessment |
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| Fibrin D dimer increased | Investigations | MedDRA 18.0 | Non-systematic Assessment |
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| Blood cholesterol increased | Investigations | MedDRA 18.0 | Non-systematic Assessment |
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| Blood creatine phosphokinase increased | Investigations | MedDRA 18.0 | Non-systematic Assessment |
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| Gamma-glutamyltransferase increased | Investigations | MedDRA 18.0 | Non-systematic Assessment |
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| Glucose urine present | Investigations | MedDRA 18.0 | Non-systematic Assessment |
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| Hepatic enzyme increased | Investigations | MedDRA 18.0 | Non-systematic Assessment |
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| Blood creatine phosphokinase MB increased | Investigations | MedDRA 18.0 | Non-systematic Assessment |
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| Blood glucose increased | Investigations | MedDRA 18.0 | Non-systematic Assessment |
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| Blood iron decreased | Investigations | MedDRA 18.0 | Non-systematic Assessment |
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| C-reactive protein increased | Investigations | MedDRA 18.0 | Non-systematic Assessment |
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| Haemoglobin decreased | Investigations | MedDRA 18.0 | Non-systematic Assessment |
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| Protein urine present | Investigations | MedDRA 18.0 | Non-systematic Assessment |
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| Urine ketone body present | Investigations | MedDRA 18.0 | Non-systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Non-systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Non-systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 18.0 | Non-systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA 18.0 | Non-systematic Assessment |
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| Syncope | Nervous system disorders | MedDRA 18.0 | Non-systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA 18.0 | Non-systematic Assessment |
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| Sleep disorder | Psychiatric disorders | MedDRA 18.0 | Non-systematic Assessment |
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| Depression | Psychiatric disorders | MedDRA 18.0 | Non-systematic Assessment |
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| Haematuria | Renal and urinary disorders | MedDRA 18.0 | Non-systematic Assessment |
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| Leukocyturia | Renal and urinary disorders | MedDRA 18.0 | Non-systematic Assessment |
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| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Non-systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Non-systematic Assessment |
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| Catarrh | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Non-systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Non-systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Non-systematic Assessment |
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| Pruritus generalised | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Non-systematic Assessment |
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| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Non-systematic Assessment |
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| Erythema | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Non-systematic Assessment |
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| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Non-systematic Assessment |
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| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Non-systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA 18.0 | Non-systematic Assessment |
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Not provided
Not provided
| Day 1 Indurations: none (n=8,8,8,9,8) |
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| Day 1 Indurations: mild (n=8,8,8,9,8) |
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| Day 1 Itching: none (n=8,8,8,9,8) |
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| Day 1 Itching: mild (n=8,8,8,9,8) |
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| Day 1 Redness: none (n=8,8,8,9,8) |
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| Day 1 Redness: mild (n=8,8,8,9,8) |
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| Day 1 Swelling: none (n=8,8,8,9,8) |
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| Day 1 Swelling: mild (n=8,8,8,9,8) |
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| Day 2 Bruising: none (n=8,8,8,9,8) |
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| Day 2 Bruising: mild (n=8,8,8,9,8) |
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| Day 2 Indurations: none (n=8,8,8,9,8) |
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| Day 2 Itching: none (n=8,8,8,9,8) |
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| Day 2 Redness: none (n=8,8,8,9,8) |
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| Day 2 Swelling: none (n=8,8,8,9,8) |
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| Day 8 Bruising: none (n=8,8,8,8,8) |
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| Day 8 Indurations: none (n=8,8,8,8,8) |
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| Day 8 Itching: none (n=8,8,8,8,8) |
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| Day 8 Redness: none (n=8,8,8,8,8) |
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| Day 8 Redness: mild (n=8,8,8,8,8) |
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| Day 8 Swelling: none (n=8,8,8,8,8) |
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| Day 15 Bruising: none (n=8,8,8,8,8) |
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| Day 15 Indurations: none (n=8,8,8,8,8) |
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| Day 15 Itching: none (n=8,8,8,8,8) |
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| Day 15 Redness: none (n=8,8,8,8,8) |
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| Day 15 Redness: mild (n=8,8,8,8,8) |
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| Day 15 Redness: moderate (n=8,8,8,8,8) |
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| Day 15 Swelling: none (n=8,8,8,8,8) |
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| Day 16 Bruising: none (n=8,8,8,8,8) |
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| Day 16 Bruising: mild (n=8,8,8,8,8) |
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| Day 16 Indurations: none (n=8,8,8,8,8) |
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| Day 16 Itching: none (n=8,8,8,8,8) |
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| Day 16 Redness: none (n=8,8,8,8,8) |
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| Day 16 Redness: mild (n=8,8,8,8,8) |
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| Day 16 Swelling: none (n=8,8,8,8,8) |
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| Day 16 Swelling: mild (n=8,8,8,8,8) |
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| Day 22 Bruising: none (n=8,8,8,8,8) |
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| Day 22 Bruising: mild (n=8,8,8,8,8) |
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| Day 22 Indurations: none (n=8,8,8,8,8) |
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| Day 22 Indurations: severe (n=8,8,8,8,8) |
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| Day 22 Itching: none (n=8,8,8,8,8) |
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| Day 22 Itching: mild (n=8,8,8,8,8) |
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| Day 22 Redness: none (n=8,8,8,8,8) |
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| Day 22 Redness: severe (n=8,8,8,8,8) |
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| Day 22 Swelling: none (n=8,8,8,8,8) |
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| Day 22 Swelling: severe (n=8,8,8,8,8) |
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| Day 29 Bruising: none (n=8,8,8,7,8) |
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| Day 29 Indurations: none (n=8,8,7,7,8) |
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| Day 29 Itching: none (n=8,8,8,7,8) |
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| Day 29 Redness: none (n=8,8,8,8,8) |
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| Day 29 Redness: mild (n=8,8,8,8,8) |
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| Day 29 Redness: moderate (n=8,8,8,8,8) |
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| Day 29 Swelling: none (n=8,8,8,7,8) |
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| Day 29 Swelling: mild (n=8,8,8,7,8) |
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| Day 30 Bruising: none (n=8,8,8,7,8) |
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| Day 30 Bruising: mild (n=8,8,8,7,8) |
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| Day 30 Indurations: none (n=8,8,7,7,8) |
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| Day 30 Itching: none (n=8,8,7,7,8) |
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| Day 30 Redness: none (n==8,8,7,7,8) |
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| Day 30 Redness: moderate (n=8,8,7,7,8) |
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| Day 30 Swelling: none (n=8,8,7,7,8) |
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| Day 36 Bruising: none (n=7,8,7,7,8) |
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| Day 36 Bruising: mild (n=7,8,7,7,8) |
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| Day 36 Indurations: none (n=8,8,7,7,7) |
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| Day 36 Itching: none (n=7,8,7,6,8) |
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| Day 43 Bruising: none (n=8,8,8,8,8) |
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| Day 43 Indurations: none (n=8,8,8,8,8) |
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| Day 43 Itching: none (8,8,8,8,8) |
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| Day 43 Redness: none (n=8,8,8,8,8) |
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| Day 43 Redness: moderate (n=8,8,8,8,8) |
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| Day 43 Swelling: none (n=8,8,8,8,8) |
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| Day 2 (n=1,1,1,1,0) |
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| Day 8 (n=1,1,0,0,0) |
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| Day 15 (n=2,1,3,0,0) |
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| Day 16 (n=0,0,0,0,2) |
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| Day 22 (1,0,1,0,0) |
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| Day 29 (n=1,1,1,0,0) |
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| Day 30 (1,0,1,1,0) |
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| Day 36 (n=0,0,0,0,0) |
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| Day 43 (n=0,0,0,0,0) |
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| Title | Measurements |
|---|
|
| Day 8 Subject 4: MSB0010841 30 mg |
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| Day 8 Subject 5: MSB0010841 30 mg |
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| Day 8 Subject 6: MSB0010841 30 mg |
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| Day 8 Subject 7: MSB0010841 60 mg |
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| Day 8 Subject 8: MSB0010841 120 mg |
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| Day 8 Subject 9: MSB0010841 120 mg |
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| Day 8 Subject 10: MSB0010841 120 mg |
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| Day 8 Subject 11: MSB0010841 120 mg |
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| Day 8 Subject 12: MSB0010841 120 mg |
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| Day 8 Subject 13: MSB0010841 240 mg |
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| Day 15 (pre-dose) Subject 1: Placebo |
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| Day 15 (pre-dose) Subject 2: Placebo |
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| Day 15 (pre-dose) Subject 3: Placebo |
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| Day 15 (pre-dose) Subject 4: MSB0010841 30 mg |
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| Day 15 (pre-dose) Subject 5: MSB0010841 30 mg |
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| Day 15 (pre-dose) Subject 6: MSB0010841 30 mg |
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| Day 15 (pre-dose) Subject 7: MSB0010841 60 mg |
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| Day 15 (pre-dose) Subject 8: MSB0010841 120 mg |
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| Day 15 (pre-dose) Subject 9: MSB0010841 120 mg |
|
| Day 15 (pre-dose) Subject 10: MSB0010841 120 mg |
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| Day 15 (pre-dose) Subject 11: MSB0010841 120 mg |
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| Day 15 (pre-dose) Subject 12: MSB0010841 120 mg |
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| Day 15 (pre-dose) Subject 13: MSB0010841 240 mg |
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| Day 22 Subject 1: Placebo |
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| Day 22 Subject 2: Placebo |
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| Day 22 Subject 3: Placebo |
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| Day 22 Subject 4: MSB0010841 30 mg |
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| Day 22 Subject 5: MSB0010841 30 mg |
|
| Day 22 Subject 6: MSB0010841 30 mg |
|
| Day 22 Subject 7: MSB0010841 60 mg |
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| Day 22 Subject 8: MSB0010841 120 mg |
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| Day 22 Subject 9: MSB0010841 120 mg |
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| Day 22 Subject 10: MSB0010841 120 mg |
|
| Day 22 Subject 11: MSB0010841 120 mg |
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| Day 22 Subject 12: MSB0010841 120 mg |
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| Day 22 Subject 13: MSB0010841 240 mg |
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| Day 29 (pre-dose) Subject 1: Placebo |
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| Day 29 (pre-dose) Subject 2: Placebo |
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| Day 29 (pre-dose) Subject 3: Placebo |
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| Day 29 (pre-dose) Subject 4: MSB0010841 30 mg |
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| Day 29 (pre-dose) Subject 5: MSB0010841 30 mg |
|
| Day 29 (pre-dose) Subject 6: MSB0010841 30 mg |
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| Day 29 (pre-dose) Subject 7: MSB0010841 60 mg |
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| Day 29 (pre-dose) Subject 8: MSB0010841 120 mg |
|
| Day 29 (pre-dose) Subject 9: MSB0010841 120 mg |
|
| Day 29 (pre-dose) Subject 10: MSB0010841 120 mg |
|
| Day 29 (pre-dose) Subject 11: MSB0010841 120 mg |
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| Day 29 (pre-dose) Subject 12: MSB0010841 120 mg |
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| Day 29 (pre-dose) Subject 13: MSB0010841 240 mg |
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| Day 36 Subject 1: Placebo |
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| Day 36 Subject 2: Placebo |
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| Day 36 Subject 3: Placebo |
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| Day 36 Subject 4: MSB0010841 30 mg |
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| Day 36 Subject 5: MSB0010841 30 mg |
|
| Day 36 Subject 6: MSB0010841 30 mg |
|
| Day 36 Subject 7: MSB0010841 60 mg |
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| Day 36 Subject 8: MSB0010841 120 mg |
|
| Day 36 Subject 9: MSB0010841 120 mg |
|
| Day 36 Subject 10: MSB0010841 120 mg |
|
| Day 36 Subject 11: MSB0010841 120 mg |
|
| Day 36 Subject 12: MSB0010841 120 mg |
|
| Day 36 Subject 13: MSB0010841 240 mg |
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| Day 43 Subject 1: Placebo |
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| Day 43 Subject 2: Placebo |
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| Day 43 Subject 3: Placebo |
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| Day 43 Subject 4: MSB0010841 30 mg |
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| Day 43 Subject 5: MSB0010841 30 mg |
|
| Day 43 Subject 6: MSB0010841 30 mg |
|
| Day 43 Subject 7: MSB0010841 60 mg |
|
| Day 43 Subject 8: MSB0010841 120 mg |
|
| Day 43 Subject 9: MSB0010841 120 mg |
|
| Day 43 Subject 10: MSB0010841 120 mg |
|
| Day 43 Subject 11: MSB0010841 120 mg |
|
| Day 43 Subject 12: MSB0010841 120 mg |
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| Day 43 Subject 13: MSB0010841 240 mg |
|
| Day 63 Subject 1: Placebo |
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| Day 63 Subject 2: Placebo |
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| Day 63 Subject 3: Placebo |
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| Day 63 Subject 4: MSB0010841 30 mg |
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| Day 63 Subject 5: MSB0010841 30 mg |
|
| Day 63 Subject 6: MSB0010841 30 mg |
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| Day 63 Subject 7: MSB0010841 60 mg |
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| Day 63 Subject 8: MSB0010841 120 mg |
|
| Day 63 Subject 9: MSB0010841 120 mg |
|
| Day 63 Subject 10: MSB0010841 120 mg |
|
| Day 63 Subject 11: MSB0010841 120 mg |
|
| Day 63 Subject 12: MSB0010841 120 mg |
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| Day 63 Subject 13: MSB0010841 240 mg |
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| Day 85 Subject 1: Placebo |
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| Day 85 Subject 2: Placebo |
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| Day 85 Subject 3: Placebo |
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| Day 85 Subject 4: MSB0010841 30 mg |
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| Day 85 Subject 5: MSB0010841 30 mg |
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| Day 85 Subject 6: MSB0010841 30 mg |
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| Day 85 Subject 7: MSB0010841 60 mg |
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| Day 85 Subject 8: MSB0010841 120 mg |
|
| Day 85 Subject 9: MSB0010841 120 mg |
|
| Day 85 Subject 10: MSB0010841 120 mg |
|
| Day 85 Subject 11: MSB0010841 120 mg |
|
| Day 85 Subject 12: MSB0010841 120 mg |
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| Day 85 Subject 13: MSB0010841 240 mg |
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| Measurements |
|---|
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| Subject 4: MSB0010841 30 mg |
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| Subject 5: MSB0010841 30 mg |
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| Subject 6: MSB0010841 30 mg |
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| Subject 7: MSB0010841 60 mg |
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| Subject 8: MSB0010841 120 mg |
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| Subject 9: MSB0010841 120 mg |
|
| Subject 10: MSB0010841 120 mg |
|
| Subject 11: MSB0010841 120 mg |
|
| Subject 12: MSB0010841 120 mg |
|
| Subject 13: MSB0010841 240 mg |
|
| 6 hour (n=8,8,8,9) |
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| 12 hour (n=8,8,8,9) |
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| 24 hour (n=8,8,8,9) |
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| 32 hour (n=8,8,8,9) |
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| 72 hour (n=8,8,7,8) |
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| 96 hour (n=8,8,8,8) |
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| 168 hour (n=8,8,8,8) |
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| 336 hour (n=8,8,8,8) |
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| 24 hour |
|
| 72 hour |
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| 96 hour |
|
| 168 hour |
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| 336 hour |
|
| 6 hour |
|
| 12 hour |
|
| 24 hour |
|
| 32 hour |
|
| 72 hour |
|
| 96 hour |
|
| 168 hour |
|
| 336 hour |
|
| 504 hour |
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| 816 hour |
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| 1056 hour |
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| 1344 hour |
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| PASI-75 |
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| Change at Day 43 |
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| Day 15 |
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| Day 22 |
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| Day 29 |
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| Day 36 |
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| Day 43 |
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| Day 50 |
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| Day 85 |
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| Change at Day 15 (n=8,8,8,8,8) |
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| Change at Day 22 (n=8,8,8,8,8) |
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| Change at Day 29 (n=8,8,8,8,8) |
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| Change at Day 36 (8,8,7,7,7) |
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| Change at Day 43 (8,8,8,9,8) |
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| Change at Day 50 (n=8,8,8,9,8) |
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| Change at Day 85 (8,8,8,9,8) |
|