Trial Outcomes & Findings for Multiple Ascending Dose Trial of MSB0010841 (Anti-IL17A/F Nanobody) in Psoriasis Subjects (NCT NCT02156466)

Last Updated: 2017-01-19

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

41 participants

Primary outcome timeframe

Baseline up to Day 85

Results posted on

2017-01-19

Participant Flow

A total of 41 subjects were randomized in the trial and included in the Safety analysis set.

Participant milestones

Participant milestones
Measure	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.	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.	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.	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.	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.
Overall Study STARTED	8	8	8	9	8
Overall Study COMPLETED	8	8	7	7	8
Overall Study NOT COMPLETED	0	0	1	2	0

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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.	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.	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.	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.
Overall Study Adverse Event	0	0	1	1	0
Overall Study Quantiferon Positivity	0	0	0	1	0

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	MSB0010841 30 mg n=8 Participants 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.	MSB0010841 60 mg n=8 Participants 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.	MSB0010841 120 mg n=8 Participants 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.	MSB0010841 240 mg n=9 Participants 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.	Placebo n=8 Participants 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.	Total n=41 Participants Total of all reporting groups
Age, Continuous	48.6 years STANDARD_DEVIATION 13.24 • n=5 Participants	42.1 years STANDARD_DEVIATION 19.57 • n=7 Participants	43.8 years STANDARD_DEVIATION 13.59 • n=5 Participants	44.8 years STANDARD_DEVIATION 15.65 • n=4 Participants	46.1 years STANDARD_DEVIATION 14.57 • n=21 Participants	45.1 years STANDARD_DEVIATION 14.87 • n=10 Participants
Gender Female	1 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	1 Participants n=4 Participants	2 Participants n=21 Participants	6 Participants n=10 Participants
Gender Male	7 Participants n=5 Participants	8 Participants n=7 Participants	6 Participants n=5 Participants	8 Participants n=4 Participants	6 Participants n=21 Participants	35 Participants n=10 Participants

PRIMARY outcome

Timeframe: Baseline up to Day 85

Population: Safety analysis set included all 41 subjects who received at least 1 dose of IMP (MSB0010841 or placebo).

Outcome measures

Outcome measures
Measure	MSB0010841 30 mg n=8 Participants 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.	MSB0010841 60 mg n=8 Participants 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.	MSB0010841 120 mg n=8 Participants 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.	MSB0010841 240 mg n=9 Participants 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.	Placebo n=8 Participants 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.
Number of Subjects With Treatment Emergent Adverse Events (TEAEs)	6 subjects	5 subjects	5 subjects	6 subjects	6 subjects

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	MSB0010841 30 mg n=8 Participants 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.	MSB0010841 60 mg n=8 Participants 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.	MSB0010841 120 mg n=8 Participants 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.	MSB0010841 240 mg n=9 Participants 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.	Placebo n=8 Participants 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.
Number of Subjects With Local Injection Site Reactions (ISRs) Day 1 Bruising: none (n=8,8,8,9,8)	8 subjects	8 subjects	8 subjects	9 subjects	8 subjects
Number of Subjects With Local Injection Site Reactions (ISRs) Day 1 Indurations: none (n=8,8,8,9,8)	8 subjects	8 subjects	7 subjects	9 subjects	8 subjects
Number of Subjects With Local Injection Site Reactions (ISRs) Day 1 Indurations: mild (n=8,8,8,9,8)	0 subjects	0 subjects	1 subjects	0 subjects	0 subjects
Number of Subjects With Local Injection Site Reactions (ISRs) Day 1 Itching: none (n=8,8,8,9,8)	8 subjects	8 subjects	8 subjects	8 subjects	9 subjects
Number of Subjects With Local Injection Site Reactions (ISRs) Day 1 Itching: mild (n=8,8,8,9,8)	0 subjects	0 subjects	0 subjects	1 subjects	0 subjects
Number of Subjects With Local Injection Site Reactions (ISRs) Day 1 Redness: none (n=8,8,8,9,8)	8 subjects	7 subjects	8 subjects	8 subjects	6 subjects
Number of Subjects With Local Injection Site Reactions (ISRs) Day 1 Redness: mild (n=8,8,8,9,8)	0 subjects	1 subjects	0 subjects	1 subjects	2 subjects
Number of Subjects With Local Injection Site Reactions (ISRs) Day 1 Swelling: none (n=8,8,8,9,8)	8 subjects	7 subjects	8 subjects	9 subjects	8 subjects
Number of Subjects With Local Injection Site Reactions (ISRs) Day 1 Swelling: mild (n=8,8,8,9,8)	0 subjects	1 subjects	0 subjects	0 subjects	0 subjects
Number of Subjects With Local Injection Site Reactions (ISRs) Day 2 Bruising: none (n=8,8,8,9,8)	5 subjects	8 subjects	8 subjects	9 subjects	8 subjects
Number of Subjects With Local Injection Site Reactions (ISRs) Day 2 Bruising: mild (n=8,8,8,9,8)	3 subjects	0 subjects	0 subjects	0 subjects	0 subjects
Number of Subjects With Local Injection Site Reactions (ISRs) Day 2 Indurations: none (n=8,8,8,9,8)	8 subjects	8 subjects	8 subjects	9 subjects	8 subjects
Number of Subjects With Local Injection Site Reactions (ISRs) Day 2 Itching: none (n=8,8,8,9,8)	8 subjects	8 subjects	8 subjects	9 subjects	8 subjects
Number of Subjects With Local Injection Site Reactions (ISRs) Day 2 Redness: none (n=8,8,8,9,8)	8 subjects	8 subjects	8 subjects	9 subjects	8 subjects
Number of Subjects With Local Injection Site Reactions (ISRs) Day 2 Swelling: none (n=8,8,8,9,8)	8 subjects	8 subjects	8 subjects	9 subjects	8 subjects
Number of Subjects With Local Injection Site Reactions (ISRs) Day 8 Bruising: none (n=8,8,8,8,8)	8 subjects	8 subjects	8 subjects	8 subjects	8 subjects
Number of Subjects With Local Injection Site Reactions (ISRs) Day 8 Indurations: none (n=8,8,8,8,8)	8 subjects	8 subjects	8 subjects	8 subjects	8 subjects
Number of Subjects With Local Injection Site Reactions (ISRs) Day 8 Itching: none (n=8,8,8,8,8)	8 subjects	8 subjects	8 subjects	8 subjects	8 subjects
Number of Subjects With Local Injection Site Reactions (ISRs) Day 8 Redness: mild (n=8,8,8,8,8)	1 subjects	0 subjects	0 subjects	0 subjects	0 subjects
Number of Subjects With Local Injection Site Reactions (ISRs) Day 8 Swelling: none (n=8,8,8,8,8)	8 subjects	8 subjects	8 subjects	8 subjects	8 subjects
Number of Subjects With Local Injection Site Reactions (ISRs) Day 15 Bruising: none (n=8,8,8,8,8)	8 subjects	8 subjects	8 subjects	8 subjects	8 subjects
Number of Subjects With Local Injection Site Reactions (ISRs) Day 15 Indurations: none (n=8,8,8,8,8)	8 subjects	8 subjects	8 subjects	8 subjects	8 subjects
Number of Subjects With Local Injection Site Reactions (ISRs) Day 15 Itching: none (n=8,8,8,8,8)	8 subjects	8 subjects	8 subjects	8 subjects	8 subjects
Number of Subjects With Local Injection Site Reactions (ISRs) Day 15 Redness: none (n=8,8,8,8,8)	8 subjects	7 subjects	7 subjects	8 subjects	8 subjects
Number of Subjects With Local Injection Site Reactions (ISRs) Day 15 Redness: mild (n=8,8,8,8,8)	0 subjects	1 subjects	0 subjects	0 subjects	0 subjects
Number of Subjects With Local Injection Site Reactions (ISRs) Day 15 Redness: moderate (n=8,8,8,8,8)	0 subjects	0 subjects	1 subjects	0 subjects	0 subjects
Number of Subjects With Local Injection Site Reactions (ISRs) Day 15 Swelling: none (n=8,8,8,8,8)	8 subjects	8 subjects	8 subjects	8 subjects	8 subjects
Number of Subjects With Local Injection Site Reactions (ISRs) Day 16 Bruising: none (n=8,8,8,8,8)	8 subjects	7 subjects	8 subjects	7 subjects	8 subjects
Number of Subjects With Local Injection Site Reactions (ISRs) Day 16 Bruising: mild (n=8,8,8,8,8)	0 subjects	1 subjects	0 subjects	1 subjects	0 subjects
Number of Subjects With Local Injection Site Reactions (ISRs) Day 16 Indurations: none (n=8,8,8,8,8)	8 subjects	8 subjects	8 subjects	8 subjects	8 subjects
Number of Subjects With Local Injection Site Reactions (ISRs) Day 16 Itching: none (n=8,8,8,8,8)	8 subjects	8 subjects	8 subjects	8 subjects	8 subjects
Number of Subjects With Local Injection Site Reactions (ISRs) Day 16 Redness: none (n=8,8,8,8,8)	7 subjects	8 subjects	8 subjects	8 subjects	8 subjects
Number of Subjects With Local Injection Site Reactions (ISRs) Day 16 Redness: mild (n=8,8,8,8,8)	1 subjects	0 subjects	0 subjects	0 subjects	0 subjects
Number of Subjects With Local Injection Site Reactions (ISRs) Day 8 Redness: none (n=8,8,8,8,8)	7 subjects	8 subjects	8 subjects	8 subjects	8 subjects
Number of Subjects With Local Injection Site Reactions (ISRs) Day 16 Swelling: none (n=8,8,8,8,8)	8 subjects	8 subjects	7 subjects	8 subjects	8 subjects
Number of Subjects With Local Injection Site Reactions (ISRs) Day 16 Swelling: mild (n=8,8,8,8,8)	0 subjects	0 subjects	1 subjects	0 subjects	0 subjects
Number of Subjects With Local Injection Site Reactions (ISRs) Day 22 Bruising: none (n=8,8,8,8,8)	8 subjects	8 subjects	8 subjects	7 subjects	8 subjects
Number of Subjects With Local Injection Site Reactions (ISRs) Day 22 Bruising: mild (n=8,8,8,8,8)	0 subjects	0 subjects	0 subjects	1 subjects	0 subjects
Number of Subjects With Local Injection Site Reactions (ISRs) Day 22 Indurations: none (n=8,8,8,8,8)	8 subjects	8 subjects	7 subjects	8 subjects	8 subjects
Number of Subjects With Local Injection Site Reactions (ISRs) Day 22 Indurations: severe (n=8,8,8,8,8)	0 subjects	0 subjects	1 subjects	0 subjects	0 subjects
Number of Subjects With Local Injection Site Reactions (ISRs) Day 22 Itching: none (n=8,8,8,8,8)	7 subjects	8 subjects	8 subjects	8 subjects	8 subjects
Number of Subjects With Local Injection Site Reactions (ISRs) Day 22 Itching: mild (n=8,8,8,8,8)	1 subjects	0 subjects	0 subjects	0 subjects	0 subjects
Number of Subjects With Local Injection Site Reactions (ISRs) Day 22 Redness: none (n=8,8,8,8,8)	8 subjects	8 subjects	7 subjects	8 subjects	8 subjects
Number of Subjects With Local Injection Site Reactions (ISRs) Day 22 Redness: severe (n=8,8,8,8,8)	0 subjects	0 subjects	1 subjects	0 subjects	0 subjects
Number of Subjects With Local Injection Site Reactions (ISRs) Day 22 Swelling: none (n=8,8,8,8,8)	8 subjects	8 subjects	7 subjects	8 subjects	8 subjects
Number of Subjects With Local Injection Site Reactions (ISRs) Day 22 Swelling: severe (n=8,8,8,8,8)	0 subjects	0 subjects	1 subjects	0 subjects	0 subjects
Number of Subjects With Local Injection Site Reactions (ISRs) Day 29 Bruising: none (n=8,8,8,7,8)	8 subjects	8 subjects	8 subjects	7 subjects	8 subjects
Number of Subjects With Local Injection Site Reactions (ISRs) Day 29 Indurations: none (n=8,8,7,7,8)	8 subjects	8 subjects	7 subjects	7 subjects	8 subjects
Number of Subjects With Local Injection Site Reactions (ISRs) Day 29 Itching: none (n=8,8,8,7,8)	8 subjects	8 subjects	8 subjects	7 subjects	8 subjects
Number of Subjects With Local Injection Site Reactions (ISRs) Day 29 Redness: none (n=8,8,8,8,8)	8 subjects	8 subjects	6 subjects	5 subjects	8 subjects
Number of Subjects With Local Injection Site Reactions (ISRs) Day 29 Redness: mild (n=8,8,8,8,8)	0 subjects	0 subjects	2 subjects	2 subjects	0 subjects
Number of Subjects With Local Injection Site Reactions (ISRs) Day 29 Redness: moderate (n=8,8,8,8,8)	0 subjects	0 subjects	0 subjects	1 subjects	0 subjects
Number of Subjects With Local Injection Site Reactions (ISRs) Day 29 Swelling: none (n=8,8,8,7,8)	8 subjects	8 subjects	7 subjects	7 subjects	8 subjects
Number of Subjects With Local Injection Site Reactions (ISRs) Day 29 Swelling: mild (n=8,8,8,7,8)	0 subjects	0 subjects	1 subjects	0 subjects	0 subjects
Number of Subjects With Local Injection Site Reactions (ISRs) Day 30 Bruising: none (n=8,8,8,7,8)	8 subjects	8 subjects	7 subjects	6 subjects	8 subjects
Number of Subjects With Local Injection Site Reactions (ISRs) Day 30 Bruising: mild (n=8,8,8,7,8)	0 subjects	0 subjects	1 subjects	1 subjects	0 subjects
Number of Subjects With Local Injection Site Reactions (ISRs) Day 30 Indurations: none (n=8,8,7,7,8)	8 subjects	8 subjects	7 subjects	7 subjects	8 subjects
Number of Subjects With Local Injection Site Reactions (ISRs) Day 30 Itching: none (n=8,8,7,7,8)	8 subjects	8 subjects	0 subjects	0 subjects	8 subjects
Number of Subjects With Local Injection Site Reactions (ISRs) Day 30 Redness: none (n==8,8,7,7,8)	8 subjects	8 subjects	7 subjects	6 subjects	8 subjects
Number of Subjects With Local Injection Site Reactions (ISRs) Day 30 Redness: moderate (n=8,8,7,7,8)	0 subjects	0 subjects	0 subjects	1 subjects	0 subjects
Number of Subjects With Local Injection Site Reactions (ISRs) Day 30 Swelling: none (n=8,8,7,7,8)	8 subjects	8 subjects	7 subjects	7 subjects	8 subjects
Number of Subjects With Local Injection Site Reactions (ISRs) Day 36 Bruising: none (n=7,8,7,7,8)	7 subjects	8 subjects	7 subjects	6 subjects	8 subjects
Number of Subjects With Local Injection Site Reactions (ISRs) Day 36 Bruising: mild (n=7,8,7,7,8)	0 subjects	0 subjects	0 subjects	1 subjects	0 subjects
Number of Subjects With Local Injection Site Reactions (ISRs) Day 36 Indurations: none (n=8,8,7,7,7)	8 subjects	8 subjects	7 subjects	7 subjects	7 subjects
Number of Subjects With Local Injection Site Reactions (ISRs) Day 36 Itching: none (n=7,8,7,6,8)	7 subjects	8 subjects	7 subjects	6 subjects	8 subjects
Number of Subjects With Local Injection Site Reactions (ISRs) Day 43 Bruising: none (n=8,8,8,8,8)	8 subjects	8 subjects	8 subjects	8 subjects	8 subjects
Number of Subjects With Local Injection Site Reactions (ISRs) Day 43 Indurations: none (n=8,8,8,8,8)	8 subjects	8 subjects	8 subjects	8 subjects	8 subjects
Number of Subjects With Local Injection Site Reactions (ISRs) Day 43 Itching: none (8,8,8,8,8)	8 subjects	8 subjects	8 subjects	8 subjects	8 subjects
Number of Subjects With Local Injection Site Reactions (ISRs) Day 43 Redness: none (n=8,8,8,8,8)	8 subjects	8 subjects	7 subjects	8 subjects	8 subjects
Number of Subjects With Local Injection Site Reactions (ISRs) Day 43 Redness: moderate (n=8,8,8,8,8)	0 subjects	0 subjects	1 subjects	0 subjects	0 subjects
Number of Subjects With Local Injection Site Reactions (ISRs) Day 43 Swelling: none (n=8,8,8,8,8)	8 subjects	8 subjects	8 subjects	8 subjects	8 subjects

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	MSB0010841 30 mg n=8 Participants 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.	MSB0010841 60 mg n=6 Participants 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.	MSB0010841 120 mg n=8 Participants 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.	MSB0010841 240 mg n=4 Participants 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.	Placebo n=8 Participants 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.
Amount of Pain at Injection Site Assessed By Visual Analog Scale (VAS) Day 29 (n=1,1,1,0,0)	3 mm	2 mm	2 mm	NA mm Data could not be calculated as there were no subjects with amount of pain value of \> 0 at the specified time point	NA mm Data could not be calculated as there were no subjects with amount of pain value of \> 0 at the specified time point
Amount of Pain at Injection Site Assessed By Visual Analog Scale (VAS) Day 1 (n=3,2,3,2,0)	7 mm	4 mm	7 mm	4 mm	NA mm Data could not be calculated as there were no subjects with amount of pain value of \> 0 at the specified time point
Amount of Pain at Injection Site Assessed By Visual Analog Scale (VAS) Day 2 (n=1,1,1,1,0)	1 mm	1 mm	1 mm	1 mm	NA mm Data could not be calculated as there were no subjects with amount of pain value of \> 0 at the specified time point
Amount of Pain at Injection Site Assessed By Visual Analog Scale (VAS) Day 8 (n=1,1,0,0,0)	1 mm	1 mm	NA mm Data could not be calculated as there were no subjects with amount of pain value of \> 0 at the specified time point	NA mm Data could not be calculated as there were no subjects with amount of pain value of \> 0 at the specified time point	NA mm Data could not be calculated as there were no subjects with amount of pain value of \> 0 at the specified time point
Amount of Pain at Injection Site Assessed By Visual Analog Scale (VAS) Day 15 (n=2,1,3,0,0)	5 mm	3 mm	7 mm	NA mm Data could not be calculated as there were no subjects with amount of pain value of \> 0 at the specified time point	NA mm Data could not be calculated as there were no subjects with amount of pain value of \> 0 at the specified time point
Amount of Pain at Injection Site Assessed By Visual Analog Scale (VAS) Day 16 (n=0,0,0,0,2)	NA mm Data could not be calculated as there were no subjects with amount of pain value of \> 0 at the specified time point	NA mm Data could not be calculated as there were no subjects with amount of pain value of \> 0 at the specified time point	NA mm Data could not be calculated as there were no subjects with amount of pain value of \> 0 at the specified time point	NA mm Data could not be calculated as there were no subjects with amount of pain value of \> 0 at the specified time point	2 mm
Amount of Pain at Injection Site Assessed By Visual Analog Scale (VAS) Day 22 (1,0,1,0,0)	11 mm	NA mm Data could not be calculated as there were no subjects with amount of pain value of \> 0 at the specified time point	1 mm	NA mm Data could not be calculated as there were no subjects with amount of pain value of \> 0 at the specified time point	NA mm Data could not be calculated as there were no subjects with amount of pain value of \> 0 at the specified time point
Amount of Pain at Injection Site Assessed By Visual Analog Scale (VAS) Day 30 (1,0,1,1,0)	2 mm	NA mm Data could not be calculated as there were no subjects with amount of pain value of \> 0 at the specified time point	1 mm	1 mm	NA mm Data could not be calculated as there were no subjects with amount of pain value of \> 0 at the specified time point
Amount of Pain at Injection Site Assessed By Visual Analog Scale (VAS) Day 36 (n=0,0,0,0,0)	NA mm Data could not be calculated as there were no subjects with amount of pain value of \> 0 at the specified time point	NA mm Data could not be calculated as there were no subjects with amount of pain value of \> 0 at the specified time point	NA mm Data could not be calculated as there were no subjects with amount of pain value of \> 0 at the specified time point	NA mm Data could not be calculated as there were no subjects with amount of pain value of \> 0 at the specified time point	NA mm Data could not be calculated as there were no subjects with amount of pain value of \> 0 at the specified time point
Amount of Pain at Injection Site Assessed By Visual Analog Scale (VAS) Day 43 (n=0,0,0,0,0)	NA mm Data could not be calculated as there were no subjects with amount of pain value of \> 0 at the specified time point	NA mm Data could not be calculated as there were no subjects with amount of pain value of \> 0 at the specified time point	NA mm Data could not be calculated as there were no subjects with amount of pain value of \> 0 at the specified time point	NA mm Data could not be calculated as there were no subjects with amount of pain value of \> 0 at the specified time point	NA mm Data could not be calculated as there were no subjects with amount of pain value of \> 0 at the specified time point

PRIMARY outcome

Timeframe: Baseline up to Day 85

Population: Safety analysis set included all 41 subjects who received at least one dose of IMP (MSB0010841 or placebo).

Data were presented for MSB0010841 combined group and placebo.

Outcome measures

Outcome measures
Measure	MSB0010841 30 mg n=33 Participants 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.	MSB0010841 60 mg n=8 Participants 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.	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.	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.	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.
Percentage of Subjects With Anti-MSB0010841 Binding Antibodies (Anti-Drug Antibodies [ADA])	30.3 percentage of subjects	37.5 percentage of subjects	—	—	—

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	MSB0010841 30 mg n=13 Participants 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.	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.	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.	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.	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.
Levels of Anti-MSB0010841 Antibody Titers Day 43 Subject 9: MSB0010841 120 mg	3.68 log10titer	—	—	—	—
Levels of Anti-MSB0010841 Antibody Titers Day 43 Subject 10: MSB0010841 120 mg	4.38 log10titer	—	—	—	—
Levels of Anti-MSB0010841 Antibody Titers Day 43 Subject 11: MSB0010841 120 mg	3.68 log10titer	—	—	—	—
Levels of Anti-MSB0010841 Antibody Titers Day 43 Subject 12: MSB0010841 120 mg	2.98 log10titer	—	—	—	—
Levels of Anti-MSB0010841 Antibody Titers Day 43 Subject 13: MSB0010841 240 mg	2.98 log10titer	—	—	—	—
Levels of Anti-MSB0010841 Antibody Titers Day 63 Subject 1: Placebo	3.68 log10titer	—	—	—	—
Levels of Anti-MSB0010841 Antibody Titers Day 63 Subject 2: Placebo	3.68 log10titer	—	—	—	—
Levels of Anti-MSB0010841 Antibody Titers Day 63 Subject 3: Placebo	3.68 log10titer	—	—	—	—
Levels of Anti-MSB0010841 Antibody Titers Day 63 Subject 4: MSB0010841 30 mg	4.38 log10titer	—	—	—	—
Levels of Anti-MSB0010841 Antibody Titers Day 63 Subject 5: MSB0010841 30 mg	0 log10titer	—	—	—	—
Levels of Anti-MSB0010841 Antibody Titers Day 63 Subject 6: MSB0010841 30 mg	2.98 log10titer	—	—	—	—
Levels of Anti-MSB0010841 Antibody Titers Day 63 Subject 7: MSB0010841 60 mg	2.28 log10titer	—	—	—	—
Levels of Anti-MSB0010841 Antibody Titers Day 63 Subject 8: MSB0010841 120 mg	2.98 log10titer	—	—	—	—
Levels of Anti-MSB0010841 Antibody Titers Day 63 Subject 9: MSB0010841 120 mg	3.68 log10titer	—	—	—	—
Levels of Anti-MSB0010841 Antibody Titers Day 63 Subject 10: MSB0010841 120 mg	3.68 log10titer	—	—	—	—
Levels of Anti-MSB0010841 Antibody Titers Day 63 Subject 11: MSB0010841 120 mg	3.68 log10titer	—	—	—	—
Levels of Anti-MSB0010841 Antibody Titers Day 63 Subject 12: MSB0010841 120 mg	3.68 log10titer	—	—	—	—
Levels of Anti-MSB0010841 Antibody Titers Day 63 Subject 13: MSB0010841 240 mg	2.98 log10titer	—	—	—	—
Levels of Anti-MSB0010841 Antibody Titers Day 85 Subject 1: Placebo	3.68 log10titer	—	—	—	—
Levels of Anti-MSB0010841 Antibody Titers Day 85 Subject 2: Placebo	3.68 log10titer	—	—	—	—
Levels of Anti-MSB0010841 Antibody Titers Day 85 Subject 3: Placebo	3.68 log10titer	—	—	—	—
Levels of Anti-MSB0010841 Antibody Titers Day 85 Subject 4: MSB0010841 30 mg	3.68 log10titer	—	—	—	—
Levels of Anti-MSB0010841 Antibody Titers Day 85 Subject 5: MSB0010841 30 mg	0 log10titer	—	—	—	—
Levels of Anti-MSB0010841 Antibody Titers Day 85 Subject 6: MSB0010841 30 mg	2.28 log10titer	—	—	—	—
Levels of Anti-MSB0010841 Antibody Titers Day 85 Subject 7: MSB0010841 60 mg	2.28 log10titer	—	—	—	—
Levels of Anti-MSB0010841 Antibody Titers Day 85 Subject 8: MSB0010841 120 mg	2.98 log10titer	—	—	—	—
Levels of Anti-MSB0010841 Antibody Titers Day 85 Subject 9: MSB0010841 120 mg	3.68 log10titer	—	—	—	—
Levels of Anti-MSB0010841 Antibody Titers Day 85 Subject 10: MSB0010841 120 mg	3.68 log10titer	—	—	—	—
Levels of Anti-MSB0010841 Antibody Titers Day 85 Subject 11: MSB0010841 120 mg	2.98 log10titer	—	—	—	—
Levels of Anti-MSB0010841 Antibody Titers Day 85 Subject 12: MSB0010841 120 mg	3.68 log10titer	—	—	—	—
Levels of Anti-MSB0010841 Antibody Titers Day 85 Subject 13: MSB0010841 240 mg	2.98 log10titer	—	—	—	—
Levels of Anti-MSB0010841 Antibody Titers Day 22 Subject 11: MSB0010841 120 mg	4.38 log10titer	—	—	—	—
Levels of Anti-MSB0010841 Antibody Titers Day 22 Subject 12: MSB0010841 120 mg	2.98 log10titer	—	—	—	—
Levels of Anti-MSB0010841 Antibody Titers Day 22 Subject 13: MSB0010841 240 mg	2.98 log10titer	—	—	—	—
Levels of Anti-MSB0010841 Antibody Titers Day 29 (pre-dose) Subject 1: Placebo	3.68 log10titer	—	—	—	—
Levels of Anti-MSB0010841 Antibody Titers Day 29 (pre-dose) Subject 2: Placebo	3.68 log10titer	—	—	—	—
Levels of Anti-MSB0010841 Antibody Titers Day 29 (pre-dose) Subject 3: Placebo	3.68 log10titer	—	—	—	—
Levels of Anti-MSB0010841 Antibody Titers Day 29 (pre-dose) Subject 4: MSB0010841 30 mg	2.98 log10titer	—	—	—	—
Levels of Anti-MSB0010841 Antibody Titers Day 29 (pre-dose) Subject 5: MSB0010841 30 mg	0 log10titer	—	—	—	—
Levels of Anti-MSB0010841 Antibody Titers Day 29 (pre-dose) Subject 6: MSB0010841 30 mg	2.98 log10titer	—	—	—	—
Levels of Anti-MSB0010841 Antibody Titers Day 29 (pre-dose) Subject 7: MSB0010841 60 mg	2.28 log10titer	—	—	—	—
Levels of Anti-MSB0010841 Antibody Titers Day 29 (pre-dose) Subject 8: MSB0010841 120 mg	3.68 log10titer	—	—	—	—
Levels of Anti-MSB0010841 Antibody Titers Day 29 (pre-dose) Subject 9: MSB0010841 120 mg	3.68 log10titer	—	—	—	—
Levels of Anti-MSB0010841 Antibody Titers Day 29 (pre-dose) Subject 10: MSB0010841 120 mg	3.68 log10titer	—	—	—	—
Levels of Anti-MSB0010841 Antibody Titers Day 29 (pre-dose) Subject 11: MSB0010841 120 mg	4.38 log10titer	—	—	—	—
Levels of Anti-MSB0010841 Antibody Titers Day 29 (pre-dose) Subject 12: MSB0010841 120 mg	2.98 log10titer	—	—	—	—
Levels of Anti-MSB0010841 Antibody Titers Day 29 (pre-dose) Subject 13: MSB0010841 240 mg	2.98 log10titer	—	—	—	—
Levels of Anti-MSB0010841 Antibody Titers Day 36 Subject 1: Placebo	NA log10titer Data were not assessed as no sample was collected at this time point	—	—	—	—
Levels of Anti-MSB0010841 Antibody Titers Day 36 Subject 2: Placebo	3.68 log10titer	—	—	—	—
Levels of Anti-MSB0010841 Antibody Titers Day 36 Subject 3: Placebo	3.68 log10titer	—	—	—	—
Levels of Anti-MSB0010841 Antibody Titers Day 36 Subject 4: MSB0010841 30 mg	2.98 log10titer	—	—	—	—
Levels of Anti-MSB0010841 Antibody Titers Day 36 Subject 5: MSB0010841 30 mg	0 log10titer	—	—	—	—
Levels of Anti-MSB0010841 Antibody Titers Day 36 Subject 6: MSB0010841 30 mg	2.98 log10titer	—	—	—	—
Levels of Anti-MSB0010841 Antibody Titers Day 36 Subject 7: MSB0010841 60 mg	2.98 log10titer	—	—	—	—
Levels of Anti-MSB0010841 Antibody Titers Day 36 Subject 8: MSB0010841 120 mg	NA log10titer Data were not assessed as no sample was collected at this time point	—	—	—	—
Levels of Anti-MSB0010841 Antibody Titers Day 36 Subject 9: MSB0010841 120 mg	3.68 log10titer	—	—	—	—
Levels of Anti-MSB0010841 Antibody Titers Day 36 Subject 10: MSB0010841 120 mg	4.38 log10titer	—	—	—	—
Levels of Anti-MSB0010841 Antibody Titers Day 36 Subject 11: MSB0010841 120 mg	4.38 log10titer	—	—	—	—
Levels of Anti-MSB0010841 Antibody Titers Day 36 Subject 12: MSB0010841 120 mg	3.68 log10titer	—	—	—	—
Levels of Anti-MSB0010841 Antibody Titers Day 36 Subject 13: MSB0010841 240 mg	2.98 log10titer	—	—	—	—
Levels of Anti-MSB0010841 Antibody Titers Day 43 Subject 1: Placebo	2.98 log10titer	—	—	—	—
Levels of Anti-MSB0010841 Antibody Titers Day 43 Subject 2: Placebo	3.68 log10titer	—	—	—	—
Levels of Anti-MSB0010841 Antibody Titers Day 43 Subject 3: Placebo	3.68 log10titer	—	—	—	—
Levels of Anti-MSB0010841 Antibody Titers Day 43 Subject 4: MSB0010841 30 mg	2.98 log10titer	—	—	—	—
Levels of Anti-MSB0010841 Antibody Titers Day 43 Subject 5: MSB0010841 30 mg	0 log10titer	—	—	—	—
Levels of Anti-MSB0010841 Antibody Titers Day 43 Subject 6: MSB0010841 30 mg	2.98 log10titer	—	—	—	—
Levels of Anti-MSB0010841 Antibody Titers Day 43 Subject 7: MSB0010841 60 mg	2.28 log10titer	—	—	—	—
Levels of Anti-MSB0010841 Antibody Titers Day 43 Subject 8: MSB0010841 120 mg	4.38 log10titer	—	—	—	—
Levels of Anti-MSB0010841 Antibody Titers Day 8 Subject 1: Placebo	3.68 log10titer	—	—	—	—
Levels of Anti-MSB0010841 Antibody Titers Day 8 Subject 2: Placebo	3.68 log10titer	—	—	—	—
Levels of Anti-MSB0010841 Antibody Titers Day 8 Subject 3: Placebo	3.68 log10titer	—	—	—	—
Levels of Anti-MSB0010841 Antibody Titers Day 8 Subject 4: MSB0010841 30 mg	3.68 log10titer	—	—	—	—
Levels of Anti-MSB0010841 Antibody Titers Day 8 Subject 5: MSB0010841 30 mg	0 log10titer	—	—	—	—
Levels of Anti-MSB0010841 Antibody Titers Day 8 Subject 6: MSB0010841 30 mg	2.28 log10titer	—	—	—	—
Levels of Anti-MSB0010841 Antibody Titers Day 8 Subject 7: MSB0010841 60 mg	0 log10titer	—	—	—	—
Levels of Anti-MSB0010841 Antibody Titers Day 8 Subject 8: MSB0010841 120 mg	3.68 log10titer	—	—	—	—
Levels of Anti-MSB0010841 Antibody Titers Day 8 Subject 9: MSB0010841 120 mg	4.38 log10titer	—	—	—	—
Levels of Anti-MSB0010841 Antibody Titers Day 8 Subject 10: MSB0010841 120 mg	3.68 log10titer	—	—	—	—
Levels of Anti-MSB0010841 Antibody Titers Day 8 Subject 11: MSB0010841 120 mg	4.38 log10titer	—	—	—	—
Levels of Anti-MSB0010841 Antibody Titers Day 8 Subject 12: MSB0010841 120 mg	2.98 log10titer	—	—	—	—
Levels of Anti-MSB0010841 Antibody Titers Day 8 Subject 13: MSB0010841 240 mg	2.98 log10titer	—	—	—	—
Levels of Anti-MSB0010841 Antibody Titers Day 15 (pre-dose) Subject 1: Placebo	3.68 log10titer	—	—	—	—
Levels of Anti-MSB0010841 Antibody Titers Day 15 (pre-dose) Subject 2: Placebo	3.68 log10titer	—	—	—	—
Levels of Anti-MSB0010841 Antibody Titers Day 15 (pre-dose) Subject 3: Placebo	3.68 log10titer	—	—	—	—
Levels of Anti-MSB0010841 Antibody Titers Day 15 (pre-dose) Subject 4: MSB0010841 30 mg	3.68 log10titer	—	—	—	—
Levels of Anti-MSB0010841 Antibody Titers Day 15 (pre-dose) Subject 5: MSB0010841 30 mg	0 log10titer	—	—	—	—
Levels of Anti-MSB0010841 Antibody Titers Day 15 (pre-dose) Subject 6: MSB0010841 30 mg	2.28 log10titer	—	—	—	—
Levels of Anti-MSB0010841 Antibody Titers Day 15 (pre-dose) Subject 7: MSB0010841 60 mg	2.98 log10titer	—	—	—	—
Levels of Anti-MSB0010841 Antibody Titers Day 15 (pre-dose) Subject 8: MSB0010841 120 mg	5.78 log10titer	—	—	—	—
Levels of Anti-MSB0010841 Antibody Titers Day 15 (pre-dose) Subject 9: MSB0010841 120 mg	4.38 log10titer	—	—	—	—
Levels of Anti-MSB0010841 Antibody Titers Day 15 (pre-dose) Subject 10: MSB0010841 120 mg	3.68 log10titer	—	—	—	—
Levels of Anti-MSB0010841 Antibody Titers Day 15 (pre-dose) Subject 11: MSB0010841 120 mg	4.38 log10titer	—	—	—	—
Levels of Anti-MSB0010841 Antibody Titers Day 15 (pre-dose) Subject 12: MSB0010841 120 mg	2.98 log10titer	—	—	—	—
Levels of Anti-MSB0010841 Antibody Titers Day 15 (pre-dose) Subject 13: MSB0010841 240 mg	2.98 log10titer	—	—	—	—
Levels of Anti-MSB0010841 Antibody Titers Day 22 Subject 1: Placebo	3.68 log10titer	—	—	—	—
Levels of Anti-MSB0010841 Antibody Titers Day 22 Subject 2: Placebo	3.68 log10titer	—	—	—	—
Levels of Anti-MSB0010841 Antibody Titers Day 22 Subject 3: Placebo	3.68 log10titer	—	—	—	—
Levels of Anti-MSB0010841 Antibody Titers Day 22 Subject 4: MSB0010841 30 mg	3.68 log10titer	—	—	—	—
Levels of Anti-MSB0010841 Antibody Titers Day 22 Subject 5: MSB0010841 30 mg	2.98 log10titer	—	—	—	—
Levels of Anti-MSB0010841 Antibody Titers Day 22 Subject 6: MSB0010841 30 mg	2.98 log10titer	—	—	—	—
Levels of Anti-MSB0010841 Antibody Titers Day 22 Subject 7: MSB0010841 60 mg	2.28 log10titer	—	—	—	—
Levels of Anti-MSB0010841 Antibody Titers Day 22 Subject 8: MSB0010841 120 mg	2.98 log10titer	—	—	—	—
Levels of Anti-MSB0010841 Antibody Titers Day 22 Subject 9: MSB0010841 120 mg	4.38 log10titer	—	—	—	—
Levels of Anti-MSB0010841 Antibody Titers Day 22 Subject 10: MSB0010841 120 mg	3.68 log10titer	—	—	—	—

PRIMARY outcome

Timeframe: Pre-dose on Day 1

Outcome measures

Outcome measures
Measure	MSB0010841 30 mg n=13 Participants 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.	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.	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.	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.	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.
Levels of Pre-existing Anti-MSB0010841 Antibody Titers Subject 1: Placebo	2.98 log10titer	—	—	—	—
Levels of Pre-existing Anti-MSB0010841 Antibody Titers Subject 2: Placebo	3.68 log10titer	—	—	—	—
Levels of Pre-existing Anti-MSB0010841 Antibody Titers Subject 3: Placebo	3.68 log10titer	—	—	—	—
Levels of Pre-existing Anti-MSB0010841 Antibody Titers Subject 4: MSB0010841 30 mg	2.98 log10titer	—	—	—	—
Levels of Pre-existing Anti-MSB0010841 Antibody Titers Subject 5: MSB0010841 30 mg	0 log10titer	—	—	—	—
Levels of Pre-existing Anti-MSB0010841 Antibody Titers Subject 6: MSB0010841 30 mg	0 log10titer	—	—	—	—
Levels of Pre-existing Anti-MSB0010841 Antibody Titers Subject 7: MSB0010841 60 mg	0 log10titer	—	—	—	—
Levels of Pre-existing Anti-MSB0010841 Antibody Titers Subject 8: MSB0010841 120 mg	2.98 log10titer	—	—	—	—
Levels of Pre-existing Anti-MSB0010841 Antibody Titers Subject 9: MSB0010841 120 mg	5.08 log10titer	—	—	—	—
Levels of Pre-existing Anti-MSB0010841 Antibody Titers Subject 10: MSB0010841 120 mg	3.68 log10titer	—	—	—	—
Levels of Pre-existing Anti-MSB0010841 Antibody Titers Subject 11: MSB0010841 120 mg	3.68 log10titer	—	—	—	—
Levels of Pre-existing Anti-MSB0010841 Antibody Titers Subject 12: MSB0010841 120 mg	2.98 log10titer	—	—	—	—
Levels of Pre-existing Anti-MSB0010841 Antibody Titers Subject 13: MSB0010841 240 mg	0 log10titer	—	—	—	—

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	MSB0010841 30 mg n=8 Participants 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.	MSB0010841 60 mg n=8 Participants 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.	MSB0010841 120 mg n=8 Participants 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.	MSB0010841 240 mg n=9 Participants 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.	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.
MSB0010841 Serum Concentration Over Time After First Dose 0 hour (n=8,8,8,9)	12.6 nanogram/milliliter (ng/mL) Standard Deviation 35.71	0.0 nanogram/milliliter (ng/mL) Standard Deviation 0.00	0.0 nanogram/milliliter (ng/mL) Standard Deviation 0.00	0.0 nanogram/milliliter (ng/mL) Standard Deviation 0.00	—
MSB0010841 Serum Concentration Over Time After First Dose 6 hour (n=8,8,8,9)	907.5 nanogram/milliliter (ng/mL) Standard Deviation 523.16	2097.1 nanogram/milliliter (ng/mL) Standard Deviation 1391.43	2315.5 nanogram/milliliter (ng/mL) Standard Deviation 787.02	4858.8 nanogram/milliliter (ng/mL) Standard Deviation 2326.35	—
MSB0010841 Serum Concentration Over Time After First Dose 12 hour (n=8,8,8,9)	1793.3 nanogram/milliliter (ng/mL) Standard Deviation 761.23	3339.6 nanogram/milliliter (ng/mL) Standard Deviation 1671.29	4983.1 nanogram/milliliter (ng/mL) Standard Deviation 1501.41	9780.3 nanogram/milliliter (ng/mL) Standard Deviation 4698.97	—
MSB0010841 Serum Concentration Over Time After First Dose 24 hour (n=8,8,8,9)	2788.4 nanogram/milliliter (ng/mL) Standard Deviation 895.89	5047.8 nanogram/milliliter (ng/mL) Standard Deviation 1600.25	9131.3 nanogram/milliliter (ng/mL) Standard Deviation 2838.02	15357.6 nanogram/milliliter (ng/mL) Standard Deviation 5295.18	—
MSB0010841 Serum Concentration Over Time After First Dose 32 hour (n=8,8,8,9)	3037.3 nanogram/milliliter (ng/mL) Standard Deviation 820.76	6028.1 nanogram/milliliter (ng/mL) Standard Deviation 2269.66	11372.4 nanogram/milliliter (ng/mL) Standard Deviation 3499.37	17135.2 nanogram/milliliter (ng/mL) Standard Deviation 6032.66	—
MSB0010841 Serum Concentration Over Time After First Dose 72 hour (n=8,8,7,8)	3190.4 nanogram/milliliter (ng/mL) Standard Deviation 810.18	6492.9 nanogram/milliliter (ng/mL) Standard Deviation 1472.29	11284.1 nanogram/milliliter (ng/mL) Standard Deviation 2562.84	20536.6 nanogram/milliliter (ng/mL) Standard Deviation 6716.38	—
MSB0010841 Serum Concentration Over Time After First Dose 96 hour (n=8,8,8,8)	3155.8 nanogram/milliliter (ng/mL) Standard Deviation 879.56	6423.8 nanogram/milliliter (ng/mL) Standard Deviation 1824.46	11790.0 nanogram/milliliter (ng/mL) Standard Deviation 3319.36	18732.9 nanogram/milliliter (ng/mL) Standard Deviation 4670.66	—
MSB0010841 Serum Concentration Over Time After First Dose 168 hour (n=8,8,8,8)	2665.5 nanogram/milliliter (ng/mL) Standard Deviation 605.89	5179.5 nanogram/milliliter (ng/mL) Standard Deviation 1126.74	10318.6 nanogram/milliliter (ng/mL) Standard Deviation 2837.81	17761.9 nanogram/milliliter (ng/mL) Standard Deviation 3072.48	—
MSB0010841 Serum Concentration Over Time After First Dose 336 hour (n=8,8,8,8)	1704.3 nanogram/milliliter (ng/mL) Standard Deviation 429.78	3951.0 nanogram/milliliter (ng/mL) Standard Deviation 1353.92	6768.4 nanogram/milliliter (ng/mL) Standard Deviation 2846.24	11605.8 nanogram/milliliter (ng/mL) Standard Deviation 2065.58	—

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	MSB0010841 30 mg n=8 Participants 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.	MSB0010841 60 mg n=8 Participants 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.	MSB0010841 120 mg n=8 Participants 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.	MSB0010841 240 mg n=8 Participants 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.	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.
MSB0010841 Serum Concentration Over Time After Second Dose 72 hour	4309.0 ng/mL Standard Deviation 1265.45	9095.5 ng/mL Standard Deviation 2115.16	17454.4 ng/mL Standard Deviation 4152.32	29902.4 ng/mL Standard Deviation 7523.13	—
MSB0010841 Serum Concentration Over Time After Second Dose 96 hour	4020.5 ng/mL Standard Deviation 923.65	8514.4 ng/mL Standard Deviation 1849.44	17081.4 ng/mL Standard Deviation 5056.17	29223.5 ng/mL Standard Deviation 8336.26	—
MSB0010841 Serum Concentration Over Time After Second Dose 168 hour	3517.8 ng/mL Standard Deviation 877.96	7180.4 ng/mL Standard Deviation 1705.24	14806.6 ng/mL Standard Deviation 5632.99	22972.5 ng/mL Standard Deviation 11219.87	—
MSB0010841 Serum Concentration Over Time After Second Dose 336 hour	2306.5 ng/mL Standard Deviation 588.50	4492.9 ng/mL Standard Deviation 1398.63	10468.9 ng/mL Standard Deviation 4376.75	16454.5 ng/mL Standard Deviation 4548.85	—
MSB0010841 Serum Concentration Over Time After Second Dose 0 hour	1704.3 ng/mL Standard Deviation 429.78	3951.0 ng/mL Standard Deviation 1353.92	6768.4 ng/mL Standard Deviation 2846.24	11605.8 ng/mL Standard Deviation 2065.58	—
MSB0010841 Serum Concentration Over Time After Second Dose 24 hour	3808.0 ng/mL Standard Deviation 980.68	7268.9 ng/mL Standard Deviation 3771.98	15120.6 ng/mL Standard Deviation 3393.84	27664.8 ng/mL Standard Deviation 9231.41	—

PRIMARY outcome

Timeframe: 0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336, 504, 816, 1056, 1344 hours post-third dose (Day 29)

Outcome measures

Outcome measures
Measure	MSB0010841 30 mg n=8 Participants 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.	MSB0010841 60 mg n=8 Participants 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.	MSB0010841 120 mg n=7 Participants 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.	MSB0010841 240 mg n=7 Participants 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.	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.
MSB0010841 Serum Concentration Over Time After Third Dose 0 hour	2306.5 ng/mL Standard Deviation 588.50	4492.9 ng/mL Standard Deviation 1398.63	10417.7 ng/mL Standard Deviation 4724.84	16173.6 ng/mL Standard Deviation 4837.78	—
MSB0010841 Serum Concentration Over Time After Third Dose 6 hour	3483.9 ng/mL Standard Deviation 1566.88	6200.1 ng/mL Standard Deviation 1391.38	12725.0 ng/mL Standard Deviation 5573.11	20452.3 ng/mL Standard Deviation 6683.19	—
MSB0010841 Serum Concentration Over Time After Third Dose 12 hour	3557.9 ng/mL Standard Deviation 1004.43	8615.5 ng/mL Standard Deviation 3093.46	13361.0 ng/mL Standard Deviation 5959.26	26051.4 ng/mL Standard Deviation 8770.65	—
MSB0010841 Serum Concentration Over Time After Third Dose 1344 hour	244.8 ng/mL Standard Deviation 162.24	326.3 ng/mL Standard Deviation 230.87	1611.3 ng/mL Standard Deviation 2199.92	1345.7 ng/mL Standard Deviation 879.15	—
MSB0010841 Serum Concentration Over Time After Third Dose 24 hour	4533.3 ng/mL Standard Deviation 1178.14	9969.9 ng/mL Standard Deviation 2494.60	17523.1 ng/mL Standard Deviation 6140.31	33651.7 ng/mL Standard Deviation 11590.56	—
MSB0010841 Serum Concentration Over Time After Third Dose 32 hour	4934.5 ng/mL Standard Deviation 1256.47	10762.5 ng/mL Standard Deviation 2377.88	18634.9 ng/mL Standard Deviation 5713.14	38278.4 ng/mL Standard Deviation 13391.40	—
MSB0010841 Serum Concentration Over Time After Third Dose 72 hour	4936.0 ng/mL Standard Deviation 1387.50	10345.6 ng/mL Standard Deviation 4586.24	19813.1 ng/mL Standard Deviation 6381.27	37166.4 ng/mL Standard Deviation 10103.58	—
MSB0010841 Serum Concentration Over Time After Third Dose 96 hour	4994.9 ng/mL Standard Deviation 1448.53	9047.6 ng/mL Standard Deviation 2760.25	18260.1 ng/mL Standard Deviation 6602.90	33909.3 ng/mL Standard Deviation 10219.54	—
MSB0010841 Serum Concentration Over Time After Third Dose 168 hour	4368.1 ng/mL Standard Deviation 1201.56	7715.4 ng/mL Standard Deviation 3019.93	15585.3 ng/mL Standard Deviation 5625.65	31375.9 ng/mL Standard Deviation 6826.50	—
MSB0010841 Serum Concentration Over Time After Third Dose 336 hour	2680.5 ng/mL Standard Deviation 859.35	5602.1 ng/mL Standard Deviation 3057.34	12257.6 ng/mL Standard Deviation 7468.85	20011.9 ng/mL Standard Deviation 6248.98	—
MSB0010841 Serum Concentration Over Time After Third Dose 504 hour	1802.0 ng/mL Standard Deviation 505.42	3109.1 ng/mL Standard Deviation 1519.66	8610.6 ng/mL Standard Deviation 5991.68	12472.4 ng/mL Standard Deviation 4176.00	—
MSB0010841 Serum Concentration Over Time After Third Dose 816 hour	933.1 ng/mL Standard Deviation 376.76	1378.1 ng/mL Standard Deviation 834.66	4309.3 ng/mL Standard Deviation 4044.88	5064.6 ng/mL Standard Deviation 2070.93	—
MSB0010841 Serum Concentration Over Time After Third Dose 1056 hour	464.5 ng/mL Standard Deviation 257.13	658.5 ng/mL Standard Deviation 391.39	2599.7 ng/mL Standard Deviation 2937.08	2475.9 ng/mL Standard Deviation 1391.08	—

PRIMARY outcome

Timeframe: 0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336 hours post-first dose (Day 1)

Area under the serum concentration-time curve (AUC) from time zero to the last sampling time point at which the concentration is at or above lower limit of quantification (LLOQ).

Outcome measures

Outcome measures
Measure	MSB0010841 30 mg n=8 Participants 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.	MSB0010841 60 mg n=8 Participants 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.	MSB0010841 120 mg n=8 Participants 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.	MSB0010841 240 mg n=8 Participants 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.	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.
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUC0-t) Post First Dose of MSB0010841	33.6 daymicrogram per milliliter (daymcg/mL Geometric Coefficient of Variation 28.0	69.3 daymicrogram per milliliter (daymcg/mL Geometric Coefficient of Variation 18.9	126.3 daymicrogram per milliliter (daymcg/mL Geometric Coefficient of Variation 28.5	216.5 daymicrogram per milliliter (daymcg/mL Geometric Coefficient of Variation 23.4	—

PRIMARY outcome

Timeframe: 0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336, 504, 816, 1056, 1344 hours post-third dose (Day 29)

Area under the serum concentration-time curve (AUC) from time zero to the last sampling time point at which the concentration is at or above LLOQ.

Outcome measures

Outcome measures
Measure	MSB0010841 30 mg n=8 Participants 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.	MSB0010841 60 mg n=8 Participants 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.	MSB0010841 120 mg n=7 Participants 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.	MSB0010841 240 mg n=7 Participants 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.	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.
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUC0-t) Post Third Dose of MSB0010841	93.7 day*mcg/mL Geometric Coefficient of Variation 41.4	170.3 day*mcg/mL Geometric Coefficient of Variation 39.5	371.7 day*mcg/mL Geometric Coefficient of Variation 62.0	663.4 day*mcg/mL Geometric Coefficient of Variation 31.1	—

PRIMARY outcome

Timeframe: 0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336 hours post-first dose (Day 1)

Area under the concentration-time curve from time zero up to time Tau, where Tau is the dosing interval (336 hours).

Outcome measures

Outcome measures
Measure	MSB0010841 30 mg n=5 Participants 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.	MSB0010841 60 mg n=6 Participants 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.	MSB0010841 120 mg n=6 Participants 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.	MSB0010841 240 mg n=5 Participants 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.	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.
Area Under the Concentration-Time Curve From Time Zero up to Time Tau (AUCtau) Post First Dose of MSB0010841	32.4 day*mcg/mL Geometric Coefficient of Variation 31.2	68.3 day*mcg/mL Geometric Coefficient of Variation 16.4	114.6 day*mcg/mL Geometric Coefficient of Variation 24.2	222.2 day*mcg/mL Geometric Coefficient of Variation 19.6	—

PRIMARY outcome

Timeframe: 0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336 hours post-third dose (Day 29)

Area under the concentration-time curve from time zero up to time Tau, where Tau is the dosing interval (336 hours).

Outcome measures

Outcome measures
Measure	MSB0010841 30 mg n=8 Participants 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.	MSB0010841 60 mg n=8 Participants 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.	MSB0010841 120 mg n=7 Participants 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.	MSB0010841 240 mg n=7 Participants 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.	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.
Area Under the Concentration-Time Curve From Time Zero up to Time Tau (AUCtau) Post Third Dose of MSB0010841	54.2 day*mcg/mL Geometric Coefficient of Variation 36.3	104.1 day*mcg/mL Geometric Coefficient of Variation 33.9	203.2 day*mcg/mL Geometric Coefficient of Variation 43.6	397.6 day*mcg/mL Geometric Coefficient of Variation 27.1	—

PRIMARY outcome

Timeframe: 0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336, 504, 816, 1056, 1344 hours post-third dose (Day 29)

Area under the serum concentration-time curve from time zero to infinity (AUC0-inf). AUC0-infcalculated as AUC0-t + AUCextra. AUCextra represents the extrapolated part of AUC0-inf calculated by Clast calc/λz, where Clast calc is the calculated concentration at the last sampling time point at which the measured concentration is at or above LLOQ and λz is the terminal rate constant determined from the terminal slope of the log transformed concentration curve using linear regression on terminal data points of the curve.

Outcome measures

Outcome measures
Measure	MSB0010841 30 mg n=8 Participants 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.	MSB0010841 60 mg n=8 Participants 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.	MSB0010841 120 mg n=8 Participants 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.	MSB0010841 240 mg n=8 Participants 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.	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.
Area Under the Concentration-time Curve From Time Zero to Infinity (AUC 0-inf) Post Third Dose of MSB0010841	97.6 day*ug/mL Geometric Coefficient of Variation 42.2	174.9 day*ug/mL Geometric Coefficient of Variation 39.9	392.6 day*ug/mL Geometric Coefficient of Variation 68.8	680.9 day*ug/mL Geometric Coefficient of Variation 32.2	—

PRIMARY outcome

Timeframe: Pre-dose (0 hours) on Day 1

The observed serum concentration immediately before the first dose.

Outcome measures

Outcome measures
Measure	MSB0010841 30 mg n=8 Participants 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.	MSB0010841 60 mg n=8 Participants 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.	MSB0010841 120 mg n=8 Participants 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.	MSB0010841 240 mg n=8 Participants 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.	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.
Observed Serum Concentration Immediately Before First Dose (Cpre) of MSB0010841	0.01 mcg/mL Standard Deviation 0.036	0.00 mcg/mL Standard Deviation 0.000	0.00 mcg/mL Standard Deviation 0.000	0.00 mcg/mL Standard Deviation 0.000	—

PRIMARY outcome

Timeframe: Pre-dose (0 hours) on Day 29

The observed serum concentration immediately before the third dose.

Outcome measures

Outcome measures
Measure	MSB0010841 30 mg n=8 Participants 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.	MSB0010841 60 mg n=8 Participants 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.	MSB0010841 120 mg n=7 Participants 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.	MSB0010841 240 mg n=7 Participants 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.	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.
Observed Serum Concentration Immediately Before Third Dose (Cpre) of MSB0010841	2.31 mcg/mL Standard Deviation 0.59	4.49 mcg/mL Standard Deviation 1.40	10.42 mcg/mL Standard Deviation 4.72	16.17 mcg/mL Standard Deviation 4.84	—

PRIMARY outcome

Timeframe: 0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336 hours post-first dose (Day 1)

The observed minimum serum concentration determined directly from the serum concentration-time profile of each subject.

Outcome measures

Outcome measures
Measure	MSB0010841 30 mg n=8 Participants 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.	MSB0010841 60 mg n=8 Participants 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.	MSB0010841 120 mg n=8 Participants 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.	MSB0010841 240 mg n=8 Participants 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.	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.
Minimum Concentration Observed (Cmin) During First Dosing Interval of MSB0010841	0.01 mcg/mL Standard Deviation 0.036	0.00 mcg/mL Standard Deviation 0.000	0.00 mcg/mL Standard Deviation 0.000	0.00 mcg/mL Standard Deviation 0.000	—

PRIMARY outcome

Timeframe: 0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336, 504, 816, 1056, 1344 hours post-third dose (Day 29)

The observed minimum serum concentration determined directly from the serum concentration-time profile of each subject.

Outcome measures

Outcome measures
Measure	MSB0010841 30 mg n=8 Participants 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.	MSB0010841 60 mg n=8 Participants 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.	MSB0010841 120 mg n=7 Participants 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.	MSB0010841 240 mg n=7 Participants 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.	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.
Minimum Concentration Observed (Cmin) During Third Dosing Interval of MSB0010841	2.30 mcg/mL Standard Deviation 0.60	4.34 mcg/mL Standard Deviation 1.40	10.03 mcg/mL Standard Deviation 4.95	16.17 mcg/mL Standard Deviation 4.84	—

PRIMARY outcome

Timeframe: 0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336 hours post-first dose (Day 1)

Outcome measures

Outcome measures
Measure	MSB0010841 30 mg n=8 Participants 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.	MSB0010841 60 mg n=8 Participants 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.	MSB0010841 120 mg n=8 Participants 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.	MSB0010841 240 mg n=8 Participants 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.	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.
Maximum Concentration Observed (Cmax) Post First Dose of MSB0010841	3.3 mcg/mL Geometric Coefficient of Variation 28.4	7.4 mcg/mL Geometric Coefficient of Variation 22.9	12.5 mcg/mL Geometric Coefficient of Variation 25.6	20.8 mcg/mL Geometric Coefficient of Variation 30.3	—

PRIMARY outcome

Timeframe: 0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336, 504, 816, 1056, 1344 hours post-third dose (Day 29)

Outcome measures

Outcome measures
Measure	MSB0010841 30 mg n=8 Participants 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.	MSB0010841 60 mg n=8 Participants 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.	MSB0010841 120 mg n=7 Participants 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.	MSB0010841 240 mg n=7 Participants 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.	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.
Maximum Concentration Observed (Cmax) Post Third Dose of MSB0010841	5.14 mcg/mL Geometric Coefficient of Variation 34.5	11.32 mcg/mL Geometric Coefficient of Variation 29.7	19.74 mcg/mL Geometric Coefficient of Variation 31.3	37.93 mcg/mL Geometric Coefficient of Variation 32.2	—

PRIMARY outcome

Timeframe: 0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336 hours post-first dose (Day 1)

Cav was calculated by AUCtau/tau. Where tau is the dosing interval (336 hours).

Outcome measures

Outcome measures
Measure	MSB0010841 30 mg n=5 Participants 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.	MSB0010841 60 mg n=6 Participants 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.	MSB0010841 120 mg n=6 Participants 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.	MSB0010841 240 mg n=5 Participants 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.	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.
Average Concentration (Cav) Post First Dose of MSB0010841	2.315 mcg/mL Geometric Coefficient of Variation 31.2	4.881 mcg/mL Geometric Coefficient of Variation 16.4	8.187 mcg/mL Geometric Coefficient of Variation 24.2	15.868 mcg/mL Geometric Coefficient of Variation 19.6	—

PRIMARY outcome

Timeframe: 0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336, 504, 816, 1056, 1344 hours post-third dose (Day 29)

Cav was calculated by AUCtau/tau. Where tau is the dosing interval (336 hours).

Outcome measures

Outcome measures
Measure	MSB0010841 30 mg n=8 Participants 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.	MSB0010841 60 mg n=8 Participants 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.	MSB0010841 120 mg n=7 Participants 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.	MSB0010841 240 mg n=7 Participants 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.	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.
Average Concentration (Cav) Post Third Dose of MSB0010841	3.87 mcg/mL Geometric Coefficient of Variation 36.3	7.44 mcg/mL Geometric Coefficient of Variation 33.9	14.51 mcg/mL Geometric Coefficient of Variation 43.6	28.40 mcg/mL Geometric Coefficient of Variation 27.1	—

PRIMARY outcome

Timeframe: 0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336 hours post-first dose (Day 1)

MRT is the average time at which the number of absorbed molecules reside in the body, after single-dose administration, and calculated as AUMC(0-t)/AUC(0-t) where AUMC(0-t) is area under the plasma concentration-time first moment curve from time zero to time t (336 hours) and AUC(0-t) is the area under the plasma concentration-time curve from time zero to tome t (336 hours).

Outcome measures

Outcome measures
Measure	MSB0010841 30 mg n=8 Participants 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.	MSB0010841 60 mg n=8 Participants 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.	MSB0010841 120 mg n=8 Participants 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.	MSB0010841 240 mg n=8 Participants 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.	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.
Mean Residence Time (MRT0-t) Post First Dose of MSB0010841	6.528 day Geometric Coefficient of Variation 3.6	6.691 day Geometric Coefficient of Variation 8.1	6.638 day Geometric Coefficient of Variation 5.7	6.771 day Geometric Coefficient of Variation 5.3	—

PRIMARY outcome

Timeframe: 0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336 hours post-third dose (Day 29)

Outcome measures

Outcome measures
Measure	MSB0010841 30 mg n=8 Participants 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.	MSB0010841 60 mg n=8 Participants 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.	MSB0010841 120 mg n=8 Participants 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.	MSB0010841 240 mg n=8 Participants 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.	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.
Mean Residence Time (MRT0-t) Post Third Dose of MSB0010841	17.57 day Geometric Coefficient of Variation 11.2	15.68 day Geometric Coefficient of Variation 16.3	19.26 day Geometric Coefficient of Variation 32.0	16.38 day Geometric Coefficient of Variation 11.3	—

PRIMARY outcome

Timeframe: 0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336, 504, 816, 1056, 1344 hours post-third dose (Day 29)

Mean residence time of drug in the body from time zero extrapolated to infinity, based on the last predicted concentration at tlast.

Outcome measures

Outcome measures
Measure	MSB0010841 30 mg n=8 Participants 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.	MSB0010841 60 mg n=8 Participants 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.	MSB0010841 120 mg n=7 Participants 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.	MSB0010841 240 mg n=7 Participants 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.	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.
Mean Residence Time of Drug in the Body From Time Zero Extrapolated to Infinity (MRT(0-inf) Post Third Dose of MSB0010841	17.57 day Geometric Coefficient of Variation 11.2	15.68 day Geometric Coefficient of Variation 16.3	19.26 day Geometric Coefficient of Variation 32.0	16.38 day Geometric Coefficient of Variation 11.3	—

PRIMARY outcome

Timeframe: 0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336 hours post-first dose (Day 1)

Outcome measures

Outcome measures
Measure	MSB0010841 30 mg n=8 Participants 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.	MSB0010841 60 mg n=8 Participants 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.	MSB0010841 120 mg n=8 Participants 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.	MSB0010841 240 mg n=8 Participants 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.	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.
Time to Reach Maximum Observed Concentration (Tmax) Post First Dose of MSB0010841	72.39 hour Interval 23.9 to 97.4	71.68 hour Interval 24.0 to 335.8	52.00 hour Interval 32.0 to 96.2	72.23 hour Interval 72.0 to 168.0	—

PRIMARY outcome

Timeframe: 0 hours (pre-dose), 24, 72, 96, 168, 336 hours post-second dose (Day 15)

Outcome measures

Outcome measures
Measure	MSB0010841 30 mg n=8 Participants 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.	MSB0010841 60 mg n=8 Participants 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.	MSB0010841 120 mg n=8 Participants 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.	MSB0010841 240 mg n=8 Participants 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.	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.
Time to Maximum Observed Concentration (Tmax) Post Second Dose of MSB0010841	84.2 hour Interval 72.0 to 97.5	72.0 hour Interval 24.1 to 96.6	83.4 hour Interval 71.8 to 168.0	72.0 hour Interval 24.0 to 168.0	—

PRIMARY outcome

Timeframe: 0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336, 504, 816, 1056, 1344 hours post-third dose (Day 29)

Outcome measures

Outcome measures
Measure	MSB0010841 30 mg n=8 Participants 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.	MSB0010841 60 mg n=8 Participants 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.	MSB0010841 120 mg n=7 Participants 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.	MSB0010841 240 mg n=7 Participants 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.	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.
Time to Reach Maximum Observed Concentration (Tmax) Post Third Dose of MSB0010841	31.5 hour Interval 6.0 to 95.8	31.0 hour Interval 12.0 to 72.4	72.0 hour Interval 31.8 to 72.5	72.0 hour Interval 31.1 to 168.0	—

PRIMARY outcome

Timeframe: 0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336, 504, 816, 1056, 1344 hours post-third dose (Day 29)

Terminal half-life is the time measured for the concentration to decrease by one half. Terminal half-life is calculated by dividing the natural logarithm to the base e (Log e) multiplied by (\*) 2/ λz, where 'λz' is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.

Outcome measures

Outcome measures
Measure	MSB0010841 30 mg n=8 Participants 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.	MSB0010841 60 mg n=8 Participants 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.	MSB0010841 120 mg n=8 Participants 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.	MSB0010841 240 mg n=8 Participants 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.	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.
Apparent Terminal Half-life (t1/2) Post Third Dose of MSB0010841	10.63 day Geometric Coefficient of Variation 17.3	10.50 day Geometric Coefficient of Variation 18.9	12.19 day Geometric Coefficient of Variation 27.9	10.25 day Geometric Coefficient of Variation 13.1	—

PRIMARY outcome

Timeframe: 0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336, 504, 816, 1056, 1344 hours post-third dose (Day 29)

Terminal rate constant was determined from the terminal slope of the logtransformed concentration curve using linear regression on terminal data points of the curve

Outcome measures

Outcome measures
Measure	MSB0010841 30 mg n=8 Participants 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.	MSB0010841 60 mg n=8 Participants 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.	MSB0010841 120 mg n=8 Participants 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.	MSB0010841 240 mg n=8 Participants 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.	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.
Terminal Rate Constant (λz) Post Third Dose of MSB0010841	0.00 1/hour Geometric Coefficient of Variation 17.3	0.00 1/hour Geometric Coefficient of Variation 18.9	0.00 1/hour Geometric Coefficient of Variation 27.9	0.00 1/hour Geometric Coefficient of Variation 13.1	—

PRIMARY outcome

Timeframe: 0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336, 504, 816, 1056, 1344 hours post-third dose (Day 29)

Clearance of a drug was a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Apparent clearance after oral dose (CL/f) is influenced by the fraction absorbed.

Outcome measures

Outcome measures
Measure	MSB0010841 30 mg n=8 Participants 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.	MSB0010841 60 mg n=8 Participants 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.	MSB0010841 120 mg n=7 Participants 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.	MSB0010841 240 mg n=7 Participants 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.	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.
Apparent Clearance (CL/f) Post Third Dose of MSB0010841	0.55 L/day Geometric Coefficient of Variation 36.3	0.58 L/day Geometric Coefficient of Variation 33.9	0.59 L/day Geometric Coefficient of Variation 43.6	0.60 L/day Geometric Coefficient of Variation 27.1	—

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	MSB0010841 30 mg n=8 Participants 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.	MSB0010841 60 mg n=8 Participants 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.	MSB0010841 120 mg n=7 Participants 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.	MSB0010841 240 mg n=7 Participants 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.	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.
Apparent Volume of Distribution During Terminal Phase (Vz/f) Post Third Dose of MSB0010841	8.49 Liters Geometric Coefficient of Variation 27.0	8.73 Liters Geometric Coefficient of Variation 38.6	10.39 Liters Geometric Coefficient of Variation 21.9	8.92 Liters Geometric Coefficient of Variation 18.8	—

PRIMARY outcome

Timeframe: 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.

The peak trough fluctuation within one dosing interval, calculated as PTF (%) = (\[Cmax - Cmin\]/Cav ) multiplied by 100

Outcome measures

Outcome measures
Measure	MSB0010841 30 mg n=5 Participants 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.	MSB0010841 60 mg n=6 Participants 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.	MSB0010841 120 mg n=6 Participants 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.	MSB0010841 240 mg n=5 Participants 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.	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.
Percentage Peak-Trough Fluctuation (PTF) Post First Dose of MSB0010841	140.28 percentage fluctuation Geometric Coefficient of Variation 3.9	152.47 percentage fluctuation Geometric Coefficient of Variation 20.4	144.37 percentage fluctuation Geometric Coefficient of Variation 13.0	135.89 percentage fluctuation Geometric Coefficient of Variation 12.3	—

PRIMARY outcome

Timeframe: 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.

The peak trough fluctuation within one dosing interval, calculated as PTF (%) = (\[Cmax - Cmin\]/Cav ) multiplied by 100

Outcome measures

Outcome measures
Measure	MSB0010841 30 mg n=8 Participants 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.	MSB0010841 60 mg n=8 Participants 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.	MSB0010841 120 mg n=7 Participants 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.	MSB0010841 240 mg n=7 Participants 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.	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.
Percentage Peak-Trough Fluctuation (PTF) Post Third Dose of MSB0010841	75.26 percentage fluctuation Geometric Coefficient of Variation 8.5	95.65 percentage fluctuation Geometric Coefficient of Variation 18.9	71.17 percentage fluctuation Geometric Coefficient of Variation 33.1	76.03 percentage fluctuation Geometric Coefficient of Variation 28.6	—

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	MSB0010841 30 mg n=8 Participants 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.	MSB0010841 60 mg n=8 Participants 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.	MSB0010841 120 mg n=8 Participants 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.	MSB0010841 240 mg n=8 Participants 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.	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.
Accumulation Ratio of Cmax (Racc (Cmax))	1.56 ratio Geometric Coefficient of Variation 17.9	1.52 ratio Geometric Coefficient of Variation 23.5	1.56 ratio Geometric Coefficient of Variation 34.1	1.81 ratio Geometric Coefficient of Variation 9.5	—

PRIMARY outcome

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.

Outcome measures

Outcome measures
Measure	MSB0010841 30 mg n=8 Participants 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.	MSB0010841 60 mg n=8 Participants 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.	MSB0010841 120 mg n=8 Participants 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.	MSB0010841 240 mg n=8 Participants 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.	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.
Accumulation Ratio of AUC (Racc(AUC))	1.61 ratio Geometric Coefficient of Variation 15.9	1.50 ratio Geometric Coefficient of Variation 18.4	1.61 ratio Geometric Coefficient of Variation 27.4	1.83 ratio Geometric Coefficient of Variation 11.5	—

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	MSB0010841 30 mg n=8 Participants 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.	MSB0010841 60 mg n=8 Participants 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.	MSB0010841 120 mg n=8 Participants 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.	MSB0010841 240 mg n=8 Participants 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.	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.
Maximum Observed Concentration (Cmax) Post Second Dose of MSB0010841	4.26 mcg/mL Geometric Coefficient of Variation 32.7	9.06 mcg/mL Geometric Coefficient of Variation 24.2	18.59 mcg/mL Geometric Coefficient of Variation 23.1	30.98 mcg/mL Geometric Coefficient of Variation 25.3	—

PRIMARY outcome

Timeframe: Pre-dose (0 hours) on Day 15

The observed serum concentration immediately before second dose.

Outcome measures

Outcome measures
Measure	MSB0010841 30 mg n=8 Participants 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.	MSB0010841 60 mg n=8 Participants 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.	MSB0010841 120 mg n=8 Participants 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.	MSB0010841 240 mg n=8 Participants 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.	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.
Observed Serum Concentration Immediately Before Second Dose (Cpre) of MSB0010841	1.65 mcg/mL Geometric Coefficient of Variation 30.2	3.74 mcg/mL Geometric Coefficient of Variation 37.9	6.34 mcg/mL Geometric Coefficient of Variation 38.3	11.44 mcg/mL Geometric Coefficient of Variation 18.1	—

SECONDARY outcome

Timeframe: Baseline up to Day 85

Population: Safety analysis set included all 41 subjects who received at least 1 dose of IMP (MSB0010841 or placebo).

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.

Outcome measures

Outcome measures
Measure	MSB0010841 30 mg n=8 Participants 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.	MSB0010841 60 mg n=8 Participants 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.	MSB0010841 120 mg n=8 Participants 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.	MSB0010841 240 mg n=9 Participants 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.	Placebo n=8 Participants 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.
Percentage of Subjects With 50% or 75% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score PASI-50	100 percentage of subjects	100 percentage of subjects	100 percentage of subjects	100 percentage of subjects	50 percentage of subjects
Percentage of Subjects With 50% or 75% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score PASI-75	88 percentage of subjects	100 percentage of subjects	100 percentage of subjects	100 percentage of subjects	0 percentage of subjects

SECONDARY outcome

Timeframe: Baseline, Day 43

Population: Safety analysis set included all 41 subjects who received at least one dose of IMP (MSB0010841 or placebo).

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.

Outcome measures

Outcome measures
Measure	MSB0010841 30 mg n=8 Participants 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.	MSB0010841 60 mg n=8 Participants 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.	MSB0010841 120 mg n=8 Participants 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.	MSB0010841 240 mg n=9 Participants 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.	Placebo n=8 Participants 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.
Mean Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Day 43 Baseline	16.91 units on a scale Standard Deviation 5.75	19.76 units on a scale Standard Deviation 4.79	23.35 units on a scale Standard Deviation 6.60	18.38 units on a scale Standard Deviation 6.07	25.49 units on a scale Standard Deviation 5.58
Mean Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Day 43 Change at Day 43	-13.93 units on a scale Standard Deviation 4.76	-17.99 units on a scale Standard Deviation 5.52	-21.70 units on a scale Standard Deviation 8.52	-16.68 units on a scale Standard Deviation 8.38	-5.43 units on a scale Standard Deviation 7.04

SECONDARY outcome

Timeframe: 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).

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.

Outcome measures

Outcome measures
Measure	MSB0010841 30 mg n=8 Participants 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.	MSB0010841 60 mg n=8 Participants 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.	MSB0010841 120 mg n=8 Participants 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.	MSB0010841 240 mg n=9 Participants 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.	Placebo n=8 Participants 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.
Percentage of Subjects With Static Physician's Global Assessment (sPGA) Score of Minimal or Clear and With at Least 2 Level Reduction From Baseline Day 8	0 percentage of subjects	38 percentage of subjects	13 percentage of subjects	11 percentage of subjects	0 percentage of subjects
Percentage of Subjects With Static Physician's Global Assessment (sPGA) Score of Minimal or Clear and With at Least 2 Level Reduction From Baseline Day 15	25 percentage of subjects	25 percentage of subjects	13 percentage of subjects	56 percentage of subjects	0 percentage of subjects
Percentage of Subjects With Static Physician's Global Assessment (sPGA) Score of Minimal or Clear and With at Least 2 Level Reduction From Baseline Day 22	50 percentage of subjects	50 percentage of subjects	50 percentage of subjects	67 percentage of subjects	0 percentage of subjects
Percentage of Subjects With Static Physician's Global Assessment (sPGA) Score of Minimal or Clear and With at Least 2 Level Reduction From Baseline Day 29	63 percentage of subjects	63 percentage of subjects	88 percentage of subjects	78 percentage of subjects	0 percentage of subjects
Percentage of Subjects With Static Physician's Global Assessment (sPGA) Score of Minimal or Clear and With at Least 2 Level Reduction From Baseline Day 36	63 percentage of subjects	88 percentage of subjects	75 percentage of subjects	67 percentage of subjects	0 percentage of subjects
Percentage of Subjects With Static Physician's Global Assessment (sPGA) Score of Minimal or Clear and With at Least 2 Level Reduction From Baseline Day 43	75 percentage of subjects	88 percentage of subjects	75 percentage of subjects	67 percentage of subjects	0 percentage of subjects
Percentage of Subjects With Static Physician's Global Assessment (sPGA) Score of Minimal or Clear and With at Least 2 Level Reduction From Baseline Day 50	75 percentage of subjects	88 percentage of subjects	100 percentage of subjects	89 percentage of subjects	0 percentage of subjects
Percentage of Subjects With Static Physician's Global Assessment (sPGA) Score of Minimal or Clear and With at Least 2 Level Reduction From Baseline Day 85	88 percentage of subjects	88 percentage of subjects	88 percentage of subjects	100 percentage of subjects	0 percentage of subjects

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	MSB0010841 30 mg n=8 Participants 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.	MSB0010841 60 mg n=8 Participants 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.	MSB0010841 120 mg n=8 Participants 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.	MSB0010841 240 mg n=9 Participants 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.	Placebo n=8 Participants 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.
Mean Percent Change From Baseline in the Body Surface Area (BSA) Affected by Psoriasis at Day 8, 15, 22, 29, 36, 43, 50 and 85 Change at Day 8 (n=8,8,8,8,8)	0.4 percent change Standard Deviation 1.14	-30.0 percent change Standard Deviation 31.23	-13.7 percent change Standard Deviation 15.13	-12.5 percent change Standard Deviation 23.81	2.9 percent change Standard Deviation 23.32
Mean Percent Change From Baseline in the Body Surface Area (BSA) Affected by Psoriasis at Day 8, 15, 22, 29, 36, 43, 50 and 85 Change at Day 15 (n=8,8,8,8,8)	0.4 percent change Standard Deviation 1.14	-33.1 percent change Standard Deviation 35.97	-20.5 percent change Standard Deviation 10.98	-51.1 percent change Standard Deviation 43.17	-4.2 percent change Standard Deviation 12.21
Mean Percent Change From Baseline in the Body Surface Area (BSA) Affected by Psoriasis at Day 8, 15, 22, 29, 36, 43, 50 and 85 Change at Day 22 (n=8,8,8,8,8)	-11.6 percent change Standard Deviation 24.90	-40.2 percent change Standard Deviation 40.68	-42.6 percent change Standard Deviation 27.15	-68.5 percent change Standard Deviation 38.71	-5.1 percent change Standard Deviation 12.69
Mean Percent Change From Baseline in the Body Surface Area (BSA) Affected by Psoriasis at Day 8, 15, 22, 29, 36, 43, 50 and 85 Change at Day 29 (n=8,8,8,8,8)	-22.6 percent change Standard Deviation 26.35	-44.1 percent change Standard Deviation 42.53	-55.9 percent change Standard Deviation 36.56	-82.9 percent change Standard Deviation 34.46	-0.1 percent change Standard Deviation 26.13
Mean Percent Change From Baseline in the Body Surface Area (BSA) Affected by Psoriasis at Day 8, 15, 22, 29, 36, 43, 50 and 85 Change at Day 36 (8,8,7,7,7)	-31.4 percent change Standard Deviation 22.96	-52.7 percent change Standard Deviation 37.57	-64.6 percent change Standard Deviation 37.65	-83.5 percent change Standard Deviation 31.60	-0.5 percent change Standard Deviation 27.92
Mean Percent Change From Baseline in the Body Surface Area (BSA) Affected by Psoriasis at Day 8, 15, 22, 29, 36, 43, 50 and 85 Change at Day 43 (8,8,8,9,8)	-52.6 percent change Standard Deviation 32.91	-65.2 percent change Standard Deviation 28.61	-75.4 percent change Standard Deviation 37.35	-82.2 percent change Standard Deviation 36.64	-1.5 percent change Standard Deviation 27.05
Mean Percent Change From Baseline in the Body Surface Area (BSA) Affected by Psoriasis at Day 8, 15, 22, 29, 36, 43, 50 and 85 Change at Day 50 (n=8,8,8,9,8)	-56.2 percent change Standard Deviation 34.71	-69.4 percent change Standard Deviation 25.85	-79.1 percent change Standard Deviation 32.30	-82.2 percent change Standard Deviation 36.64	-10.0 percent change Standard Deviation 17.87
Mean Percent Change From Baseline in the Body Surface Area (BSA) Affected by Psoriasis at Day 8, 15, 22, 29, 36, 43, 50 and 85 Change at Day 85 (8,8,8,9,8)	-60.4 percent change Standard Deviation 33.51	-61.3 percent change Standard Deviation 33.89	-82.1 percent change Standard Deviation 31.05	-95.5 percent change Standard Deviation 11.02	-13.0 percent change Standard Deviation 20.13

SECONDARY outcome

Timeframe: Baseline up to Day 85

Population: Safety analysis set included all 41 subjects who received at least 1 dose of IMP (MSB0010841 or placebo).

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).

Outcome measures

Outcome measures
Measure	MSB0010841 30 mg n=8 Participants 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.	MSB0010841 60 mg n=8 Participants 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.	MSB0010841 120 mg n=8 Participants 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.	MSB0010841 240 mg n=9 Participants 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.	Placebo n=8 Participants 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.
Percentage of Subjects With Exacerbation of Psoriasis	0 percentage of subjects	0 percentage of subjects	0 percentage of subjects	0 percentage of subjects	12.5 percentage of subjects

Adverse Events

MSB0010841 30 mg

Serious events: 1 serious events

Other events: 5 other events

Deaths: 0 deaths

MSB0010841 60 mg

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

MSB0010841 120 mg

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

MSB0010841 240 mg

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	MSB0010841 30 mg n=8 participants at risk 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.	MSB0010841 60 mg n=8 participants at risk 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.	MSB0010841 120 mg n=8 participants at risk 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.	MSB0010841 240 mg n=9 participants at risk 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.	Placebo n=8 participants at risk 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.
Ear and labyrinth disorders Acute vestibular syndrome	12.5% 1/8 • Baseline up to Day 85	0.00% 0/8 • Baseline up to Day 85	0.00% 0/8 • Baseline up to Day 85	0.00% 0/9 • Baseline up to Day 85	0.00% 0/8 • Baseline up to Day 85

Other adverse events

Other adverse events
Measure	MSB0010841 30 mg n=8 participants at risk 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.	MSB0010841 60 mg n=8 participants at risk 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.	MSB0010841 120 mg n=8 participants at risk 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.	MSB0010841 240 mg n=9 participants at risk 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.	Placebo n=8 participants at risk 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.
Infections and infestations Bacterial vaginosis	0.00% 0/8 • Baseline up to Day 85	0.00% 0/8 • Baseline up to Day 85	12.5% 1/8 • Baseline up to Day 85	0.00% 0/9 • Baseline up to Day 85	0.00% 0/8 • Baseline up to Day 85
Infections and infestations Cystitis	0.00% 0/8 • Baseline up to Day 85	0.00% 0/8 • Baseline up to Day 85	12.5% 1/8 • Baseline up to Day 85	0.00% 0/9 • Baseline up to Day 85	0.00% 0/8 • Baseline up to Day 85
Infections and infestations Otitis media	0.00% 0/8 • Baseline up to Day 85	0.00% 0/8 • Baseline up to Day 85	12.5% 1/8 • Baseline up to Day 85	11.1% 1/9 • Baseline up to Day 85	0.00% 0/8 • Baseline up to Day 85
Infections and infestations Paronychia	0.00% 0/8 • Baseline up to Day 85	12.5% 1/8 • Baseline up to Day 85	0.00% 0/8 • Baseline up to Day 85	0.00% 0/9 • Baseline up to Day 85	0.00% 0/8 • Baseline up to Day 85
Blood and lymphatic system disorders Leukopenia	0.00% 0/8 • Baseline up to Day 85	12.5% 1/8 • Baseline up to Day 85	0.00% 0/8 • Baseline up to Day 85	0.00% 0/9 • Baseline up to Day 85	0.00% 0/8 • Baseline up to Day 85
Eye disorders Lacrimation increased	0.00% 0/8 • Baseline up to Day 85	12.5% 1/8 • Baseline up to Day 85	0.00% 0/8 • Baseline up to Day 85	0.00% 0/9 • Baseline up to Day 85	0.00% 0/8 • Baseline up to Day 85
Gastrointestinal disorders Hypoaesthesia oral	12.5% 1/8 • Baseline up to Day 85	0.00% 0/8 • Baseline up to Day 85	0.00% 0/8 • Baseline up to Day 85	0.00% 0/9 • Baseline up to Day 85	0.00% 0/8 • Baseline up to Day 85
Gastrointestinal disorders Toothache	12.5% 1/8 • Baseline up to Day 85	0.00% 0/8 • Baseline up to Day 85	0.00% 0/8 • Baseline up to Day 85	0.00% 0/9 • Baseline up to Day 85	0.00% 0/8 • Baseline up to Day 85
General disorders Asthenia	0.00% 0/8 • Baseline up to Day 85	0.00% 0/8 • Baseline up to Day 85	12.5% 1/8 • Baseline up to Day 85	0.00% 0/9 • Baseline up to Day 85	0.00% 0/8 • Baseline up to Day 85
General disorders Influenza like illness	0.00% 0/8 • Baseline up to Day 85	0.00% 0/8 • Baseline up to Day 85	12.5% 1/8 • Baseline up to Day 85	0.00% 0/9 • Baseline up to Day 85	0.00% 0/8 • Baseline up to Day 85
General disorders Injection site erythema	0.00% 0/8 • Baseline up to Day 85	0.00% 0/8 • Baseline up to Day 85	0.00% 0/8 • Baseline up to Day 85	11.1% 1/9 • Baseline up to Day 85	0.00% 0/8 • Baseline up to Day 85
General disorders Injection site reaction	0.00% 0/8 • Baseline up to Day 85	0.00% 0/8 • Baseline up to Day 85	12.5% 1/8 • Baseline up to Day 85	0.00% 0/9 • Baseline up to Day 85	0.00% 0/8 • Baseline up to Day 85
General disorders Injection site swelling	0.00% 0/8 • Baseline up to Day 85	0.00% 0/8 • Baseline up to Day 85	0.00% 0/8 • Baseline up to Day 85	11.1% 1/9 • Baseline up to Day 85	0.00% 0/8 • Baseline up to Day 85
General disorders Injection site urticaria	0.00% 0/8 • Baseline up to Day 85	0.00% 0/8 • Baseline up to Day 85	0.00% 0/8 • Baseline up to Day 85	11.1% 1/9 • Baseline up to Day 85	0.00% 0/8 • Baseline up to Day 85
General disorders Fatigue	0.00% 0/8 • Baseline up to Day 85	0.00% 0/8 • Baseline up to Day 85	0.00% 0/8 • Baseline up to Day 85	0.00% 0/9 • Baseline up to Day 85	12.5% 1/8 • Baseline up to Day 85
General disorders Peripheral swelling	0.00% 0/8 • Baseline up to Day 85	0.00% 0/8 • Baseline up to Day 85	0.00% 0/8 • Baseline up to Day 85	0.00% 0/9 • Baseline up to Day 85	12.5% 1/8 • Baseline up to Day 85
Hepatobiliary disorders Biliary colic	0.00% 0/8 • Baseline up to Day 85	12.5% 1/8 • Baseline up to Day 85	0.00% 0/8 • Baseline up to Day 85	0.00% 0/9 • Baseline up to Day 85	0.00% 0/8 • Baseline up to Day 85
Infections and infestations Bronchitis	0.00% 0/8 • Baseline up to Day 85	25.0% 2/8 • Baseline up to Day 85	0.00% 0/8 • Baseline up to Day 85	0.00% 0/9 • Baseline up to Day 85	0.00% 0/8 • Baseline up to Day 85
Infections and infestations Nasopharyngitis	0.00% 0/8 • Baseline up to Day 85	0.00% 0/8 • Baseline up to Day 85	12.5% 1/8 • Baseline up to Day 85	11.1% 1/9 • Baseline up to Day 85	12.5% 1/8 • Baseline up to Day 85
Infections and infestations Urinary tract infection	0.00% 0/8 • Baseline up to Day 85	0.00% 0/8 • Baseline up to Day 85	0.00% 0/8 • Baseline up to Day 85	0.00% 0/9 • Baseline up to Day 85	12.5% 1/8 • Baseline up to Day 85
Injury, poisoning and procedural complications Fall	0.00% 0/8 • Baseline up to Day 85	0.00% 0/8 • Baseline up to Day 85	12.5% 1/8 • Baseline up to Day 85	0.00% 0/9 • Baseline up to Day 85	0.00% 0/8 • Baseline up to Day 85
Injury, poisoning and procedural complications Limb injury	0.00% 0/8 • Baseline up to Day 85	0.00% 0/8 • Baseline up to Day 85	12.5% 1/8 • Baseline up to Day 85	11.1% 1/9 • Baseline up to Day 85	0.00% 0/8 • Baseline up to Day 85
Injury, poisoning and procedural complications Sunburn	0.00% 0/8 • Baseline up to Day 85	0.00% 0/8 • Baseline up to Day 85	12.5% 1/8 • Baseline up to Day 85	0.00% 0/9 • Baseline up to Day 85	0.00% 0/8 • Baseline up to Day 85
Investigations Fibrin D dimer increased	12.5% 1/8 • Baseline up to Day 85	0.00% 0/8 • Baseline up to Day 85	0.00% 0/8 • Baseline up to Day 85	0.00% 0/9 • Baseline up to Day 85	12.5% 1/8 • Baseline up to Day 85
Investigations Blood cholesterol increased	0.00% 0/8 • Baseline up to Day 85	0.00% 0/8 • Baseline up to Day 85	12.5% 1/8 • Baseline up to Day 85	0.00% 0/9 • Baseline up to Day 85	0.00% 0/8 • Baseline up to Day 85
Investigations Blood creatine phosphokinase increased	0.00% 0/8 • Baseline up to Day 85	12.5% 1/8 • Baseline up to Day 85	0.00% 0/8 • Baseline up to Day 85	0.00% 0/9 • Baseline up to Day 85	12.5% 1/8 • Baseline up to Day 85
Investigations Gamma-glutamyltransferase increased	0.00% 0/8 • Baseline up to Day 85	0.00% 0/8 • Baseline up to Day 85	12.5% 1/8 • Baseline up to Day 85	0.00% 0/9 • Baseline up to Day 85	0.00% 0/8 • Baseline up to Day 85
Investigations Glucose urine present	12.5% 1/8 • Baseline up to Day 85	0.00% 0/8 • Baseline up to Day 85	0.00% 0/8 • Baseline up to Day 85	0.00% 0/9 • Baseline up to Day 85	12.5% 1/8 • Baseline up to Day 85
Investigations Hepatic enzyme increased	0.00% 0/8 • Baseline up to Day 85	0.00% 0/8 • Baseline up to Day 85	0.00% 0/8 • Baseline up to Day 85	11.1% 1/9 • Baseline up to Day 85	0.00% 0/8 • Baseline up to Day 85
Investigations Blood creatine phosphokinase MB increased	0.00% 0/8 • Baseline up to Day 85	0.00% 0/8 • Baseline up to Day 85	0.00% 0/8 • Baseline up to Day 85	0.00% 0/9 • Baseline up to Day 85	12.5% 1/8 • Baseline up to Day 85
Investigations Blood glucose increased	0.00% 0/8 • Baseline up to Day 85	0.00% 0/8 • Baseline up to Day 85	0.00% 0/8 • Baseline up to Day 85	0.00% 0/9 • Baseline up to Day 85	12.5% 1/8 • Baseline up to Day 85
Investigations Blood iron decreased	0.00% 0/8 • Baseline up to Day 85	0.00% 0/8 • Baseline up to Day 85	0.00% 0/8 • Baseline up to Day 85	0.00% 0/9 • Baseline up to Day 85	12.5% 1/8 • Baseline up to Day 85
Investigations C-reactive protein increased	0.00% 0/8 • Baseline up to Day 85	0.00% 0/8 • Baseline up to Day 85	0.00% 0/8 • Baseline up to Day 85	0.00% 0/9 • Baseline up to Day 85	12.5% 1/8 • Baseline up to Day 85
Investigations Haemoglobin decreased	0.00% 0/8 • Baseline up to Day 85	0.00% 0/8 • Baseline up to Day 85	0.00% 0/8 • Baseline up to Day 85	0.00% 0/9 • Baseline up to Day 85	12.5% 1/8 • Baseline up to Day 85
Investigations Protein urine present	0.00% 0/8 • Baseline up to Day 85	0.00% 0/8 • Baseline up to Day 85	0.00% 0/8 • Baseline up to Day 85	0.00% 0/9 • Baseline up to Day 85	12.5% 1/8 • Baseline up to Day 85
Investigations Urine ketone body present	0.00% 0/8 • Baseline up to Day 85	0.00% 0/8 • Baseline up to Day 85	0.00% 0/8 • Baseline up to Day 85	0.00% 0/9 • Baseline up to Day 85	12.5% 1/8 • Baseline up to Day 85
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/8 • Baseline up to Day 85	12.5% 1/8 • Baseline up to Day 85	0.00% 0/8 • Baseline up to Day 85	0.00% 0/9 • Baseline up to Day 85	12.5% 1/8 • Baseline up to Day 85
Musculoskeletal and connective tissue disorders Back pain	12.5% 1/8 • Baseline up to Day 85	0.00% 0/8 • Baseline up to Day 85	0.00% 0/8 • Baseline up to Day 85	0.00% 0/9 • Baseline up to Day 85	12.5% 1/8 • Baseline up to Day 85
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/8 • Baseline up to Day 85	0.00% 0/8 • Baseline up to Day 85	0.00% 0/8 • Baseline up to Day 85	0.00% 0/9 • Baseline up to Day 85	12.5% 1/8 • Baseline up to Day 85
Nervous system disorders Headache	0.00% 0/8 • Baseline up to Day 85	25.0% 2/8 • Baseline up to Day 85	0.00% 0/8 • Baseline up to Day 85	11.1% 1/9 • Baseline up to Day 85	0.00% 0/8 • Baseline up to Day 85
Nervous system disorders Somnolence	12.5% 1/8 • Baseline up to Day 85	12.5% 1/8 • Baseline up to Day 85	0.00% 0/8 • Baseline up to Day 85	0.00% 0/9 • Baseline up to Day 85	0.00% 0/8 • Baseline up to Day 85
Nervous system disorders Syncope	0.00% 0/8 • Baseline up to Day 85	0.00% 0/8 • Baseline up to Day 85	0.00% 0/8 • Baseline up to Day 85	0.00% 0/9 • Baseline up to Day 85	12.5% 1/8 • Baseline up to Day 85
Psychiatric disorders Anxiety	12.5% 1/8 • Baseline up to Day 85	0.00% 0/8 • Baseline up to Day 85	0.00% 0/8 • Baseline up to Day 85	0.00% 0/9 • Baseline up to Day 85	0.00% 0/8 • Baseline up to Day 85
Psychiatric disorders Sleep disorder	0.00% 0/8 • Baseline up to Day 85	0.00% 0/8 • Baseline up to Day 85	12.5% 1/8 • Baseline up to Day 85	0.00% 0/9 • Baseline up to Day 85	0.00% 0/8 • Baseline up to Day 85
Psychiatric disorders Depression	0.00% 0/8 • Baseline up to Day 85	0.00% 0/8 • Baseline up to Day 85	12.5% 1/8 • Baseline up to Day 85	0.00% 0/9 • Baseline up to Day 85	12.5% 1/8 • Baseline up to Day 85
Renal and urinary disorders Haematuria	0.00% 0/8 • Baseline up to Day 85	0.00% 0/8 • Baseline up to Day 85	12.5% 1/8 • Baseline up to Day 85	0.00% 0/9 • Baseline up to Day 85	0.00% 0/8 • Baseline up to Day 85
Renal and urinary disorders Leukocyturia	0.00% 0/8 • Baseline up to Day 85	0.00% 0/8 • Baseline up to Day 85	12.5% 1/8 • Baseline up to Day 85	0.00% 0/9 • Baseline up to Day 85	0.00% 0/8 • Baseline up to Day 85
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/8 • Baseline up to Day 85	12.5% 1/8 • Baseline up to Day 85	0.00% 0/8 • Baseline up to Day 85	0.00% 0/9 • Baseline up to Day 85	0.00% 0/8 • Baseline up to Day 85
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	12.5% 1/8 • Baseline up to Day 85	0.00% 0/8 • Baseline up to Day 85	0.00% 0/8 • Baseline up to Day 85	0.00% 0/9 • Baseline up to Day 85	0.00% 0/8 • Baseline up to Day 85
Respiratory, thoracic and mediastinal disorders Catarrh	0.00% 0/8 • Baseline up to Day 85	0.00% 0/8 • Baseline up to Day 85	0.00% 0/8 • Baseline up to Day 85	11.1% 1/9 • Baseline up to Day 85	0.00% 0/8 • Baseline up to Day 85
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/8 • Baseline up to Day 85	0.00% 0/8 • Baseline up to Day 85	0.00% 0/8 • Baseline up to Day 85	11.1% 1/9 • Baseline up to Day 85	0.00% 0/8 • Baseline up to Day 85
Skin and subcutaneous tissue disorders Pruritus	25.0% 2/8 • Baseline up to Day 85	12.5% 1/8 • Baseline up to Day 85	0.00% 0/8 • Baseline up to Day 85	11.1% 1/9 • Baseline up to Day 85	12.5% 1/8 • Baseline up to Day 85
Skin and subcutaneous tissue disorders Pruritus generalised	12.5% 1/8 • Baseline up to Day 85	0.00% 0/8 • Baseline up to Day 85	0.00% 0/8 • Baseline up to Day 85	11.1% 1/9 • Baseline up to Day 85	12.5% 1/8 • Baseline up to Day 85
Skin and subcutaneous tissue disorders Alopecia	12.5% 1/8 • Baseline up to Day 85	0.00% 0/8 • Baseline up to Day 85	0.00% 0/8 • Baseline up to Day 85	0.00% 0/9 • Baseline up to Day 85	0.00% 0/8 • Baseline up to Day 85
Skin and subcutaneous tissue disorders Erythema	0.00% 0/8 • Baseline up to Day 85	12.5% 1/8 • Baseline up to Day 85	0.00% 0/8 • Baseline up to Day 85	0.00% 0/9 • Baseline up to Day 85	0.00% 0/8 • Baseline up to Day 85
Skin and subcutaneous tissue disorders Urticaria	12.5% 1/8 • Baseline up to Day 85	0.00% 0/8 • Baseline up to Day 85	0.00% 0/8 • Baseline up to Day 85	0.00% 0/9 • Baseline up to Day 85	0.00% 0/8 • Baseline up to Day 85
Skin and subcutaneous tissue disorders Psoriasis	0.00% 0/8 • Baseline up to Day 85	0.00% 0/8 • Baseline up to Day 85	0.00% 0/8 • Baseline up to Day 85	0.00% 0/9 • Baseline up to Day 85	25.0% 2/8 • Baseline up to Day 85
Vascular disorders Hypertension	0.00% 0/8 • Baseline up to Day 85	12.5% 1/8 • Baseline up to Day 85	12.5% 1/8 • Baseline up to Day 85	0.00% 0/9 • Baseline up to Day 85	12.5% 1/8 • Baseline up to Day 85

Additional Information

Merck KGaA Communication Center

Merck Healthcare, a business of Merck KGaA, Darmstadt, Germany

Phone: +49-6151-72-5200

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place