Trial Outcomes & Findings for Sprifermin (AS902330) in Cartilage Injury Repair (CIR) (NCT NCT01066871)

Last Updated: 2016-03-23

Results Overview

Percent change in cartilage defect volume was calculated based on central magnetic resonance imaging (MRI): (volume at Month 12 minus volume at baseline)\*100/volume at baseline.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

74 participants

Primary outcome timeframe

Baseline, Month 12

Results posted on

2016-03-23

Participant Flow

Participant milestones

Participant milestones
Measure	Sprifermin (AS902330) 10 mcg Sprifermin (AS902330) was administered at a dose of 10 microgram (mcg) as intra-articular injection once every week for 3 consecutive weeks.	Sprifermin (AS902330) 30 mcg Sprifermin (AS902330) was administered at a dose of 30 mcg as intra-articular injection once every week for 3 consecutive weeks.	Sprifermin (AS902330) 100 mcg Sprifermin (AS902330) was administered at a dose of 100 mcg as intra-articular injection once every week for 3 consecutive weeks.	Placebo Placebo matched to sprifermin (AS902330) was administered as intra-articular injection once every week for 3 consecutive weeks.
Overall Study STARTED	20	18	18	18
Overall Study COMPLETED	16	13	12	13
Overall Study NOT COMPLETED	4	5	6	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Sprifermin (AS902330) 10 mcg Sprifermin (AS902330) was administered at a dose of 10 microgram (mcg) as intra-articular injection once every week for 3 consecutive weeks.	Sprifermin (AS902330) 30 mcg Sprifermin (AS902330) was administered at a dose of 30 mcg as intra-articular injection once every week for 3 consecutive weeks.	Sprifermin (AS902330) 100 mcg Sprifermin (AS902330) was administered at a dose of 100 mcg as intra-articular injection once every week for 3 consecutive weeks.	Placebo Placebo matched to sprifermin (AS902330) was administered as intra-articular injection once every week for 3 consecutive weeks.
Overall Study Lost to Follow-up	0	2	2	0
Overall Study Protocol Violation	1	0	3	2
Overall Study Lack of Efficacy	0	0	0	1
Overall Study Withdrawal by Subject	3	1	0	0
Overall Study Other	0	2	1	2

Baseline Characteristics

Sprifermin (AS902330) in Cartilage Injury Repair (CIR)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sprifermin (AS902330) 10 mcg n=20 Participants Sprifermin (AS902330) was administered at a dose of 10 microgram (mcg) as intra-articular injection once every week for 3 consecutive weeks.	Sprifermin (AS902330) 30 mcg n=18 Participants Sprifermin (AS902330) was administered at a dose of 30 mcg as intra-articular injection once every week for 3 consecutive weeks.	Sprifermin (AS902330) 100 mcg n=18 Participants Sprifermin (AS902330) was administered at a dose of 100 mcg as intra-articular injection once every week for 3 consecutive weeks.	Placebo n=18 Participants Placebo matched to sprifermin (AS902330) was administered as intra-articular injection once every week for 3 consecutive weeks.	Total n=74 Participants Total of all reporting groups
Age, Customized Less than (<) 40 years	16 participants n=5 Participants	15 participants n=7 Participants	14 participants n=5 Participants	16 participants n=4 Participants	61 participants n=21 Participants
Age, Customized Greater than or equal to (>=) 40 years	4 participants n=5 Participants	3 participants n=7 Participants	4 participants n=5 Participants	2 participants n=4 Participants	13 participants n=21 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	5 Participants n=7 Participants	7 Participants n=5 Participants	3 Participants n=4 Participants	20 Participants n=21 Participants
Sex: Female, Male Male	15 Participants n=5 Participants	13 Participants n=7 Participants	11 Participants n=5 Participants	15 Participants n=4 Participants	54 Participants n=21 Participants

PRIMARY outcome

Timeframe: Baseline, Month 12

Population: The modified intent-to-treat (mITT) analysis set included all participants from the ITT analysis set who had at least 1 post-treatment magnetic resonance imaging assessment. "N" (number of participants analyzed) signifies the participants who were evaluable for this outcome measure.

Percent change in cartilage defect volume was calculated based on central magnetic resonance imaging (MRI): (volume at Month 12 minus volume at baseline)\*100/volume at baseline.

Outcome measures

Outcome measures
Measure	Sprifermin (AS902330) 10 mcg n=16 Participants Sprifermin (AS902330) was be administered at a dose of 10 microgram (mcg) as intra-articular injection once every week for 3 consecutive weeks.	Sprifermin (AS902330) 30 mcg n=14 Participants Sprifermin (AS902330) was administered at a dose of 30 mcg as intra-articular injection once every week for 3 consecutive weeks.	Sprifermin (AS902330) 100 mcg n=15 Participants Sprifermin (AS902330) was administered at a dose of 100 mcg as intra-articular injection once every week for 3 consecutive weeks.	Placebo n=16 Participants Placebo matched to sprifermin (AS902330) was administered as intra-articular injection once every week for 3 consecutive weeks.
Percent Change From Baseline in Cartilage Defect Volume at Month 12	-14.4 Percent change Standard Deviation 27.17	-17.8 Percent change Standard Deviation 29.24	-12.0 Percent change Standard Deviation 34.80	-17.0 Percent change Standard Deviation 26.65

SECONDARY outcome

Timeframe: Baseline, Months 3 and 6

Population: The mITT analysis set included all participants from the ITT analysis set who had at least 1 post-treatment magnetic resonance imaging assessment. "n" signifies the participants who were evaluable for this outcome measure for each group, respectively.

Percent change in cartilage defect volume and cartilage defect thickness at Months 3 and 6 based on central MRI was calculated as: (\[volume or thickness at Months 3 and 6 minus volume or thickness at baseline, respectively\]\*100)/volume or thickness at baseline.

Outcome measures

Outcome measures
Measure	Sprifermin (AS902330) 10 mcg n=19 Participants Sprifermin (AS902330) was be administered at a dose of 10 microgram (mcg) as intra-articular injection once every week for 3 consecutive weeks.	Sprifermin (AS902330) 30 mcg n=16 Participants Sprifermin (AS902330) was administered at a dose of 30 mcg as intra-articular injection once every week for 3 consecutive weeks.	Sprifermin (AS902330) 100 mcg n=17 Participants Sprifermin (AS902330) was administered at a dose of 100 mcg as intra-articular injection once every week for 3 consecutive weeks.	Placebo n=17 Participants Placebo matched to sprifermin (AS902330) was administered as intra-articular injection once every week for 3 consecutive weeks.
Percent Change From Baseline in Cartilage Defect Volume and Cartilage Defect Thickness in the Target Knee at Months 3 and 6 Volume: Month 3 (n=18, 16, 17, 17)	3.097 Percent change Standard Deviation 24.7727	-1.596 Percent change Standard Deviation 22.6831	-2.054 Percent change Standard Deviation 28.3639	-3.307 Percent change Standard Deviation 12.3879
Percent Change From Baseline in Cartilage Defect Volume and Cartilage Defect Thickness in the Target Knee at Months 3 and 6 Volume: Month 6 (n=17, 15, 17, 16)	0.922 Percent change Standard Deviation 28.8298	-11.118 Percent change Standard Deviation 32.3251	-7.518 Percent change Standard Deviation 32.6967	-6.792 Percent change Standard Deviation 27.8652
Percent Change From Baseline in Cartilage Defect Volume and Cartilage Defect Thickness in the Target Knee at Months 3 and 6 Thickness: Month 3 (n=18, 16, 17, 17)	3.126 Percent change Standard Deviation 9.7969	-1.969 Percent change Standard Deviation 9.2075	-1.327 Percent change Standard Deviation 16.4475	-0.810 Percent change Standard Deviation 10.9976
Percent Change From Baseline in Cartilage Defect Volume and Cartilage Defect Thickness in the Target Knee at Months 3 and 6 Thickness: Month 6 (n=17, 15, 17, 16)	3.461 Percent change Standard Deviation 11.7686	-3.184 Percent change Standard Deviation 14.1109	-5.439 Percent change Standard Deviation 16.1866	-3.106 Percent change Standard Deviation 14.1901

SECONDARY outcome

Timeframe: Baseline, Months 3, 6 and 12

The change in cartilage defect volume at Months 3, 6 and 12 based on central MRI was calculated as volume at Months 3, 6 and 12 minus volume at baseline, respectively.

Outcome measures

Outcome measures
Measure	Sprifermin (AS902330) 10 mcg n=19 Participants Sprifermin (AS902330) was be administered at a dose of 10 microgram (mcg) as intra-articular injection once every week for 3 consecutive weeks.	Sprifermin (AS902330) 30 mcg n=16 Participants Sprifermin (AS902330) was administered at a dose of 30 mcg as intra-articular injection once every week for 3 consecutive weeks.	Sprifermin (AS902330) 100 mcg n=17 Participants Sprifermin (AS902330) was administered at a dose of 100 mcg as intra-articular injection once every week for 3 consecutive weeks.	Placebo n=17 Participants Placebo matched to sprifermin (AS902330) was administered as intra-articular injection once every week for 3 consecutive weeks.
Change From Baseline in Cartilage Defect Volume in the Target Knee at Months 3, 6 and 12 Baseline (n=19, 16, 17, 17)	130.689 microliter Standard Deviation 83.7032	190.354 microliter Standard Deviation 130.5796	158.125 microliter Standard Deviation 131.2277	128.982 microliter Standard Deviation 116.9241
Change From Baseline in Cartilage Defect Volume in the Target Knee at Months 3, 6 and 12 Change at Month 3 (n=18, 16, 17, 17)	1.682 microliter Standard Deviation 30.2235	-5.588 microliter Standard Deviation 21.5146	-9.630 microliter Standard Deviation 40.2382	-7.439 microliter Standard Deviation 13.7056
Change From Baseline in Cartilage Defect Volume in the Target Knee at Months 3, 6 and 12 Change at Month 6 (n=17, 15, 17, 16)	-0.540 microliter Standard Deviation 34.6432	-29.830 microliter Standard Deviation 47.7638	-23.469 microliter Standard Deviation 59.1138	-14.511 microliter Standard Deviation 28.3908
Change From Baseline in Cartilage Defect Volume in the Target Knee at Months 3, 6 and 12 Change at Month 12 (n=16, 14, 15, 16)	-13.492 microliter Standard Deviation 40.8876	-35.800 microliter Standard Deviation 37.0570	-39.658 microliter Standard Deviation 80.5121	-25.188 microliter Standard Deviation 36.1098

SECONDARY outcome

Timeframe: Baseline, Months 3, 6 and 12

Population: The modified intent-to-treat (mITT) analysis set included all participants from the ITT analysis set who had at least 1 post-treatment magnetic resonance imaging assessment. "n" signifies the participants who were evaluable for this outcome measure for each group, respectively.

The change in cartilage defect thickness at Months 3, 6 and 12 based on central MRI was calculated as thickness at Months 3, 6 and 12 minus thickness at baseline, respectively.

Outcome measures

Outcome measures
Measure	Sprifermin (AS902330) 10 mcg n=19 Participants Sprifermin (AS902330) was be administered at a dose of 10 microgram (mcg) as intra-articular injection once every week for 3 consecutive weeks.	Sprifermin (AS902330) 30 mcg n=16 Participants Sprifermin (AS902330) was administered at a dose of 30 mcg as intra-articular injection once every week for 3 consecutive weeks.	Sprifermin (AS902330) 100 mcg n=17 Participants Sprifermin (AS902330) was administered at a dose of 100 mcg as intra-articular injection once every week for 3 consecutive weeks.	Placebo n=17 Participants Placebo matched to sprifermin (AS902330) was administered as intra-articular injection once every week for 3 consecutive weeks.
Change From Baseline in Cartilage Defect Thickness in the Target Knee at Months 3, 6 and 12 Change at Month 12 (n=16, 14, 15, 16)	-0.058 millimeter Standard Deviation 0.2648	-0.101 millimeter Standard Deviation 0.2318	-0.176 millimeter Standard Deviation 0.3274	-0.179 millimeter Standard Deviation 0.1661
Change From Baseline in Cartilage Defect Thickness in the Target Knee at Months 3, 6 and 12 Baseline (n=19, 16, 17, 17)	1.598 millimeter Standard Deviation 0.5550	1.903 millimeter Standard Deviation 0.5685	1.758 millimeter Standard Deviation 0.4901	1.641 millimeter Standard Deviation 0.5625
Change From Baseline in Cartilage Defect Thickness in the Target Knee at Months 3, 6 and 12 Change at Month 3 (n=18, 16, 17, 17)	0.028 millimeter Standard Deviation 0.1441	-0.029 millimeter Standard Deviation 0.1847	-0.046 millimeter Standard Deviation 0.2544	-0.005 millimeter Standard Deviation 0.1633
Change From Baseline in Cartilage Defect Thickness in the Target Knee at Months 3, 6 and 12 Change at Month 6 (n=17, 15, 17, 16)	0.041 millimeter Standard Deviation 0.1873	-0.066 millimeter Standard Deviation 0.2887	-0.131 millimeter Standard Deviation 0.2441	-0.043 millimeter Standard Deviation 0.2088

SECONDARY outcome

Timeframe: Months 3 (M3), 6 (M6) and 12 (M12)

MOCART scoring system (comprising 9 variables) was used to describe the morphology \& signal intensity of the repair tissue following MRI -degree of defect repair \[DDR\] score 0 (subchondral bone exposed) to 20 (complete repair); integration to the border zone \[IBZ\] score 0 (\> 50% of length of repair tissue) to 15 (complete integration to border zone);surface of repair tissue \[SRT\] score 0 (\>50% surface repair tissue/total degradation) to 10(surface intact);structure of repair tissue \[StRT\] score 0(inhomogenous/cleft formation) to 5 (homogenous);signal intensity \[T2\] Mapping Sequence \[T2MS\] and Hi-Res Sagittal Pharmacodynamic Sequence \[Hi-Res SPS\] score 0 (marked hyper intense for T2MS and hypo intense for Hi-Res SPS) to 15 (iso intense); subchondral lamina,subchondral bone score 0 (not impact) to 5 (intact);adhesions \& effusion score 0 (yes) and 5 (no). Higher values represent more favorable outcome of repair.

Outcome measures

Outcome measures
Measure	Sprifermin (AS902330) 10 mcg n=19 Participants Sprifermin (AS902330) was be administered at a dose of 10 microgram (mcg) as intra-articular injection once every week for 3 consecutive weeks.	Sprifermin (AS902330) 30 mcg n=16 Participants Sprifermin (AS902330) was administered at a dose of 30 mcg as intra-articular injection once every week for 3 consecutive weeks.	Sprifermin (AS902330) 100 mcg n=17 Participants Sprifermin (AS902330) was administered at a dose of 100 mcg as intra-articular injection once every week for 3 consecutive weeks.	Placebo n=17 Participants Placebo matched to sprifermin (AS902330) was administered as intra-articular injection once every week for 3 consecutive weeks.
Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales M12, IBZ, Complete (n=1, 2, 0, 1)	1 participants	2 participants	0 participants	1 participants
Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales M3, SRT, surface damaged < 50% (n=1, 1, 0, 2)	0 participants	0 participants	0 participants	0 participants
Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales M3, Hi-Res, Moderately hypointense (n=5, 4, 3, 6)	0 participants	0 participants	0 participants	0 participants
Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales M12, Adhesions-Yes (n=2, 5, 1, 2)	0 participants	0 participants	0 participants	0 participants
Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales M3, DDR, Complete (n=4, 4, 3, 6)	0 participants	1 participants	0 participants	0 participants
Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales M3, DDR, Hypertrophy (n=4, 4, 3, 6)	0 participants	0 participants	0 participants	0 participants
Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales M3, DDR, incomplete >50% (n=4, 4, 3, 6)	1 participants	1 participants	2 participants	1 participants
Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales M3, DDR, incomplete<50% (n=4, 4, 3, 6)	3 participants	2 participants	1 participants	5 participants
Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales M3, DDR, subchondral bone exposed (n=4, 4, 3, 6)	0 participants	0 participants	0 participants	0 participants
Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales M6, DDR, Complete (n=3, 5, 3, 6)	0 participants	1 participants	0 participants	0 participants
Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales M6, DDR, Hypertrophy (n=3, 5, 3, 6)	0 participants	0 participants	0 participants	0 participants
Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales M6, DDR, incomplete >50% (n=3, 5, 3, 6)	1 participants	1 participants	2 participants	0 participants
Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales M6, DDR, incomplete<50% (n=3, 5, 3, 6)	2 participants	3 participants	1 participants	6 participants
Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales M6, DDR, subchondral bone exposed (n=3, 5, 3, 6)	0 participants	0 participants	0 participants	0 participants
Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales M12, DDR, Complete (n=4, 8, 2, 5)	0 participants	1 participants	0 participants	0 participants
Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales M12, DDR, Hypertrophy (n=4, 8, 2, 5)	0 participants	0 participants	0 participants	0 participants
Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales M12, DDR, incomplete >50% (n=4, 8, 2, 5)	3 participants	1 participants	1 participants	0 participants
Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales M12, DDR, incomplete<50% (n=4, 8, 2, 5)	1 participants	6 participants	1 participants	5 participants
Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales M12, DDR, subchondral bone exposed (n=4, 8, 2, 5)	0 participants	0 participants	0 participants	0 participants
Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales M3, IBZ, Complete (n=1, 1, 0, 2)	1 participants	1 participants	0 participants	2 participants
Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales M3, IBZ, Incomplete (split-like) (n=1, 1, 0, 2)	0 participants	0 participants	0 participants	0 participants
Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales M3,IBZ,Defect visible<50% repair tissue(n=1,1,0,2)	0 participants	0 participants	0 participants	0 participants
Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales M3,IBZ,Defect visible>50% repair tissue(n=1,1,0,2)	0 participants	0 participants	0 participants	0 participants
Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales M6, IBZ, Complete (n=1, 2, 0, 2)	1 participants	2 participants	0 participants	2 participants
Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales M6, IBZ, Incomplete (split-like) (n=1, 2, 0, 2)	0 participants	0 participants	0 participants	0 participants
Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales M6,IBZ,Defect visible<50% repair tissue(n=1,2,0,2)	0 participants	0 participants	0 participants	0 participants
Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales M6,IBZ,Defect visible>50% repair tissue(n=1,2,0,2)	0 participants	0 participants	0 participants	0 participants
Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales M12, IBZ, Incomplete (split-like) (n=1, 2, 0, 1)	0 participants	0 participants	0 participants	0 participants
Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales M12,IBZ,Defect visible<50% repair tissue(n=1,2,0,1	0 participants	0 participants	0 participants	0 participants
Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales M12,IBZ,Defect visible>50% repair tissue(n=1,2,0,1	0 participants	0 participants	0 participants	0 participants
Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales M3, SRT, surface intact (n=1, 1, 0, 2)	1 participants	1 participants	0 participants	2 participants
Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales M3, SRT, surface damaged > 50% (n=1, 1, 0, 2)	0 participants	0 participants	0 participants	0 participants
Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales M6, SRT, surface intact (n=1, 2, 0, 2)	1 participants	2 participants	0 participants	2 participants
Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales M6, SRT, surface damaged <50% (n=1, 2, 0, 2)	0 participants	0 participants	0 participants	0 participants
Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales M6, SRT, surface damaged > 50% (n=1, 2, 0, 2)	0 participants	0 participants	0 participants	0 participants
Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales M12, SRT, surface intact (n=1, 2, 0, 1)	1 participants	2 participants	0 participants	1 participants
Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales M12, SRT, surface damaged <50% (n=1, 2, 0, 1)	0 participants	0 participants	0 participants	0 participants
Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales M12, SRT, surface damaged > 50% (n=1, 2, 0, 1)	0 participants	0 participants	0 participants	0 participants
Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales M3, StRT, Homogeneous (n=4, 3, 0, 4)	4 participants	3 participants	0 participants	4 participants
Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales M3, StRT, Inhomogenous (n=4, 3, 0, 4)	0 participants	0 participants	0 participants	0 participants
Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales M6, StRT, Homogeneous (n=3, 4, 0, 3)	3 participants	3 participants	0 participants	3 participants
Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales M6, StRT, Inhomogenous (n=3, 4, 0, 3)	0 participants	1 participants	0 participants	0 participants
Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales M12, StRT, Homogeneous (n=3, 4, 0, 2)	3 participants	3 participants	0 participants	2 participants
Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales M3, Adhesions-Yes (n=2, 3, 1, 2)	0 participants	0 participants	0 participants	0 participants
Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales M12, StRT, Inhomogenous(n=3, 4, 0, 2)	0 participants	1 participants	0 participants	0 participants
Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales M3, T2MS, Isointense (n=5, 4, 3, 6)	5 participants	4 participants	3 participants	6 participants
Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales M3, T2MS, Moderately hyperintense (n=5, 4, 3, 6)	0 participants	0 participants	0 participants	0 participants
Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales M3, T2MS, Markedly hyperintense (n=5, 4, 3, 6)	0 participants	0 participants	0 participants	0 participants
Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales M6, Adhesions-No (n=3, 3, 1, 3)	3 participants	3 participants	1 participants	3 participants
Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales M6, T2MS, Isointense (n=4, 5, 3, 6)	4 participants	5 participants	3 participants	6 participants
Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales M6, T2MS, Moderately hyperintense (n=4, 5, 3, 6)	0 participants	0 participants	0 participants	0 participants
Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales M6, Adhesions-Yes (n=3, 3, 1, 3)	0 participants	0 participants	0 participants	0 participants
Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales M6, T2MS, Markedly hyperintense (n=4, 5, 3, 6)	0 participants	0 participants	0 participants	0 participants
Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales M12, T2MS, Isointense (n=4, 8, 2, 5)	4 participants	8 participants	2 participants	5 participants
Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales M12, T2MS, Moderately hyperintense (n=4, 8, 2, 5)	0 participants	0 participants	0 participants	0 participants
Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales M12, T2MS, Markedly hyperintense (n=4, 8, 2, 5)	0 participants	0 participants	0 participants	0 participants
Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales M3, Hi-Res SPS, Isointense (n=5, 4, 3, 6)	5 participants	4 participants	3 participants	6 participants
Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales M3, Hi-Res, Markedly hypointense (n=5, 4, 3, 6)	0 participants	0 participants	0 participants	0 participants
Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales M12, Adhesions-No (n=2, 5, 1, 2)	2 participants	5 participants	1 participants	2 participants
Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales M6, Hi-Res SPS, Isointense (n=4, 5, 3, 6)	4 participants	4 participants	3 participants	6 participants
Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales M6, Hi-Res, Moderately hypointense (n=4, 5, 3, 6)	0 participants	1 participants	0 participants	0 participants
Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales M3, Effusion-No (n=18, 16, 17, 17)	5 participants	2 participants	1 participants	3 participants
Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales M3, Effusion-Yes (n=18, 16, 17, 17)	13 participants	14 participants	16 participants	14 participants
Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales M6, Effusion-No (n=17, 15, 17, 16)	4 participants	2 participants	3 participants	4 participants
Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales M6, Hi-Res, Markedly hypointense (n=4, 5, 3, 6)	0 participants	0 participants	0 participants	0 participants
Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales M12, Hi-Res SPS, Isointense (n=4, 8, 2, 5)	4 participants	6 participants	1 participants	5 participants
Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales M12, Hi-Res, Moderately hypointense (n=4, 8, 2, 5)	0 participants	2 participants	1 participants	0 participants
Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales M12, Hi-Res, Markedly hypointense (n=4, 8, 2, 5)	0 participants	0 participants	0 participants	0 participants
Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales M3, Subchondral Lamina Intact (n=17, 16, 17, 17)	17 participants	16 participants	17 participants	17 participants
Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales M6, Effusion-Yes (n=17, 15, 17, 16)	13 participants	13 participants	14 participants	12 participants
Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales M12, Effusion-No (n=16, 14, 15, 16)	3 participants	4 participants	1 participants	3 participants
Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales M12, Effusion-Yes (n=16, 14, 15, 16)	13 participants	10 participants	14 participants	13 participants
Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales M3, Subchondral Lamina Not Intact (n=17,16,17,17)	0 participants	0 participants	0 participants	0 participants
Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales M6, Subchondral Lamina Intact (n=16, 15, 17, 16)	16 participants	15 participants	17 participants	16 participants
Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales M6, Subchondral Lamina Not Intact (n=16,15,17,16)	0 participants	0 participants	0 participants	0 participants
Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales M12, Subchondral Lamina Intact (n=15, 14, 15, 16)	15 participants	14 participants	15 participants	16 participants
Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales M12,Subchondral Lamina Not Intact (n=15,14,15,16)	0 participants	0 participants	0 participants	0 participants
Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales M3, Subchondral bone Intact (n=18, 16, 17, 17)	16 participants	16 participants	17 participants	17 participants
Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales M3, Subchondral bone Not Intact (n=18, 16, 17, 17)	2 participants	0 participants	0 participants	0 participants
Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales M6, Subchondral bone Intact (n=17, 15, 17, 16)	14 participants	15 participants	16 participants	15 participants
Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales M6, Subchondral bone Not Intact (n=17, 15, 17, 16)	3 participants	0 participants	1 participants	1 participants
Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales M12, Subchondral bone Intact (n=16, 14, 15, 16)	12 participants	13 participants	14 participants	16 participants
Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales M12, Subchondral bone Not Intact (n=16, 14, 15, 16	4 participants	1 participants	1 participants	0 participants
Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales M3, Adhesions-No (n=2, 3, 1, 2)	2 participants	3 participants	1 participants	2 participants

SECONDARY outcome

Timeframe: Baseline, Month 12

The BLOKS scoring system assesses intra-articular regions within the knee according to the following features: BML size, cartilage 1, osteophyte size, synovitis, effusion, meniscal extrusion, and meniscal tear. Change from baseline in summary scores for BML size, osteophyte size, MES, and MTS were reported. Summary scores for BML size range from 0 to 27, for osteophyte size range from 0 to 36, for MES range from 0 to 12, and for MTS range from 0 to 32, with lower scores corresponding to favorable outcomes.

Outcome measures

Outcome measures
Measure	Sprifermin (AS902330) 10 mcg n=19 Participants Sprifermin (AS902330) was be administered at a dose of 10 microgram (mcg) as intra-articular injection once every week for 3 consecutive weeks.	Sprifermin (AS902330) 30 mcg n=16 Participants Sprifermin (AS902330) was administered at a dose of 30 mcg as intra-articular injection once every week for 3 consecutive weeks.	Sprifermin (AS902330) 100 mcg n=17 Participants Sprifermin (AS902330) was administered at a dose of 100 mcg as intra-articular injection once every week for 3 consecutive weeks.	Placebo n=17 Participants Placebo matched to sprifermin (AS902330) was administered as intra-articular injection once every week for 3 consecutive weeks.
Change From Baseline in Boston Leeds Osteoarthritis Knee Score (BLOKS) Sub-scale (Bone Marrow Lesion [BML] Size, Osteophyte Size, Meniscal Extrusion Score [MES], and Meniscal Tear Score [MTS]) Scores at Month 12 BML: Baseline (n=19, 16, 17, 17)	1.68 units on a scale Standard Deviation 2.262	1.75 units on a scale Standard Deviation 2.933	1.24 units on a scale Standard Deviation 1.348	1.94 units on a scale Standard Deviation 2.512
Change From Baseline in Boston Leeds Osteoarthritis Knee Score (BLOKS) Sub-scale (Bone Marrow Lesion [BML] Size, Osteophyte Size, Meniscal Extrusion Score [MES], and Meniscal Tear Score [MTS]) Scores at Month 12 MES: Baseline (n=19, 16, 17, 17)	0.26 units on a scale Standard Deviation 0.452	0.25 units on a scale Standard Deviation 0.577	0.47 units on a scale Standard Deviation 0.800	0.24 units on a scale Standard Deviation 0.562
Change From Baseline in Boston Leeds Osteoarthritis Knee Score (BLOKS) Sub-scale (Bone Marrow Lesion [BML] Size, Osteophyte Size, Meniscal Extrusion Score [MES], and Meniscal Tear Score [MTS]) Scores at Month 12 BML: Change at Month 12(n=16, 14, 15, 16)	-0.69 units on a scale Standard Deviation 2.089	-1.07 units on a scale Standard Deviation 3.149	-0.27 units on a scale Standard Deviation 1.033	-0.88 units on a scale Standard Deviation 1.455
Change From Baseline in Boston Leeds Osteoarthritis Knee Score (BLOKS) Sub-scale (Bone Marrow Lesion [BML] Size, Osteophyte Size, Meniscal Extrusion Score [MES], and Meniscal Tear Score [MTS]) Scores at Month 12 Osteophyte: Baseline (n=19, 16, 17, 17)	0.37 units on a scale Standard Deviation 0.831	0.00 units on a scale Standard Deviation 0.000	0.88 units on a scale Standard Deviation 1.799	0.24 units on a scale Standard Deviation 0.664
Change From Baseline in Boston Leeds Osteoarthritis Knee Score (BLOKS) Sub-scale (Bone Marrow Lesion [BML] Size, Osteophyte Size, Meniscal Extrusion Score [MES], and Meniscal Tear Score [MTS]) Scores at Month 12 Osteophyte: Change at Month12 (n=16, 14, 15, 16)	-0.06 units on a scale Standard Deviation 0.250	0.07 units on a scale Standard Deviation 0.267	0.47 units on a scale Standard Deviation 0.990	0.06 units on a scale Standard Deviation 0.250
Change From Baseline in Boston Leeds Osteoarthritis Knee Score (BLOKS) Sub-scale (Bone Marrow Lesion [BML] Size, Osteophyte Size, Meniscal Extrusion Score [MES], and Meniscal Tear Score [MTS]) Scores at Month 12 MES: Change at Month 12 (n=16, 14, 15, 16)	0.13 units on a scale Standard Deviation 0.342	0.00 units on a scale Standard Deviation 0.00	0.00 units on a scale Standard Deviation 0.00	0.00 units on a scale Standard Deviation 0.00
Change From Baseline in Boston Leeds Osteoarthritis Knee Score (BLOKS) Sub-scale (Bone Marrow Lesion [BML] Size, Osteophyte Size, Meniscal Extrusion Score [MES], and Meniscal Tear Score [MTS]) Scores at Month 12 MTS: Baseline (n=19, 16, 17, 17)	1.05 units on a scale Standard Deviation 1.508	0.38 units on a scale Standard Deviation 0.719	0.88 units on a scale Standard Deviation 1.219	0.53 units on a scale Standard Deviation 0.800
Change From Baseline in Boston Leeds Osteoarthritis Knee Score (BLOKS) Sub-scale (Bone Marrow Lesion [BML] Size, Osteophyte Size, Meniscal Extrusion Score [MES], and Meniscal Tear Score [MTS]) Scores at Month 12 MTS: Change at Month 12 (n=16, 14, 15, 16)	0.13 units on a scale Standard Deviation 0.500	0.00 units on a scale Standard Deviation 0.00	0.00 units on a scale Standard Deviation 0.00	0.00 units on a scale Standard Deviation 0.365

SECONDARY outcome

Timeframe: Month 12

Population: The mITT analysis set included all participants from the ITT analysis set who had at least 1 post-treatment magnetic resonance imaging assessment.

The BLOKS scoring system assesses intra-articular regions within the knee according to the following features: BML size, cartilage 1, osteophyte size, synovitis, effusion, meniscal extrusion, and meniscal tear. Total number of participants with shift from baseline in various BLOKS sub-scales (cartilage 1 \[patella medial, patella lateral, femur medial trochlea, femur lateral trochlea, medial weight bearing femur, lateral weight bearing femur, tibia medial, tibia lateral\], synovitis, and effusion) scores at Month 12 were reported.

Outcome measures

Outcome measures
Measure	Sprifermin (AS902330) 10 mcg n=19 Participants Sprifermin (AS902330) was be administered at a dose of 10 microgram (mcg) as intra-articular injection once every week for 3 consecutive weeks.	Sprifermin (AS902330) 30 mcg n=16 Participants Sprifermin (AS902330) was administered at a dose of 30 mcg as intra-articular injection once every week for 3 consecutive weeks.	Sprifermin (AS902330) 100 mcg n=17 Participants Sprifermin (AS902330) was administered at a dose of 100 mcg as intra-articular injection once every week for 3 consecutive weeks.	Placebo n=17 Participants Placebo matched to sprifermin (AS902330) was administered as intra-articular injection once every week for 3 consecutive weeks.
Number of Participants With Shift From Baseline in BLOKS Sub-Scales (Cartilage 1, Synovitis, Effusion) Scores at Month 12 Cartilage 1 patella medial	3 participants	1 participants	0 participants	3 participants
Number of Participants With Shift From Baseline in BLOKS Sub-Scales (Cartilage 1, Synovitis, Effusion) Scores at Month 12 Cartilage 1 patella lateral	3 participants	1 participants	3 participants	3 participants
Number of Participants With Shift From Baseline in BLOKS Sub-Scales (Cartilage 1, Synovitis, Effusion) Scores at Month 12 Cartilage 1 femur medial trochlea	2 participants	1 participants	1 participants	1 participants
Number of Participants With Shift From Baseline in BLOKS Sub-Scales (Cartilage 1, Synovitis, Effusion) Scores at Month 12 Cartilage 1 femur lateral trochlea	3 participants	0 participants	1 participants	1 participants
Number of Participants With Shift From Baseline in BLOKS Sub-Scales (Cartilage 1, Synovitis, Effusion) Scores at Month 12 Cartilage 1 medial weight bearing femur	9 participants	4 participants	2 participants	3 participants
Number of Participants With Shift From Baseline in BLOKS Sub-Scales (Cartilage 1, Synovitis, Effusion) Scores at Month 12 Cartilage 1 lateral weight bearing femur	2 participants	3 participants	2 participants	2 participants
Number of Participants With Shift From Baseline in BLOKS Sub-Scales (Cartilage 1, Synovitis, Effusion) Scores at Month 12 Cartilage 1 tibia medial	0 participants	0 participants	1 participants	1 participants
Number of Participants With Shift From Baseline in BLOKS Sub-Scales (Cartilage 1, Synovitis, Effusion) Scores at Month 12 Cartilage 1 tibia lateral	0 participants	2 participants	2 participants	0 participants
Number of Participants With Shift From Baseline in BLOKS Sub-Scales (Cartilage 1, Synovitis, Effusion) Scores at Month 12 Synovitis	0 participants	1 participants	0 participants	0 participants
Number of Participants With Shift From Baseline in BLOKS Sub-Scales (Cartilage 1, Synovitis, Effusion) Scores at Month 12 Effusion	13 participants	11 participants	13 participants	8 participants

SECONDARY outcome

Timeframe: Baseline, Months 6 and 12

The ICRS grading is used to score the amount of cartilage repair and damage. The grades range from 1 to 4 where higher grades indicate more severity of injury. Number of participants with change value of -3, -2, -1, 0, 1, and 2 from baseline in ICRS grade at Months 6 and 12 were reported. Lower change value indicates less severity of injury.

Outcome measures

Outcome measures
Measure	Sprifermin (AS902330) 10 mcg n=19 Participants Sprifermin (AS902330) was be administered at a dose of 10 microgram (mcg) as intra-articular injection once every week for 3 consecutive weeks.	Sprifermin (AS902330) 30 mcg n=16 Participants Sprifermin (AS902330) was administered at a dose of 30 mcg as intra-articular injection once every week for 3 consecutive weeks.	Sprifermin (AS902330) 100 mcg n=17 Participants Sprifermin (AS902330) was administered at a dose of 100 mcg as intra-articular injection once every week for 3 consecutive weeks.	Placebo n=17 Participants Placebo matched to sprifermin (AS902330) was administered as intra-articular injection once every week for 3 consecutive weeks.
Number of Participants With Change From Baseline in International Cartilage Repair Society (ICRS) Grade at Months 6 and 12 Month 6: Change value of -3 (n=17, 15, 17, 16)	0 participants	0 participants	0 participants	0 participants
Number of Participants With Change From Baseline in International Cartilage Repair Society (ICRS) Grade at Months 6 and 12 Month 6: Change value of -2 (n=17, 15, 17, 16)	0 participants	3 participants	1 participants	0 participants
Number of Participants With Change From Baseline in International Cartilage Repair Society (ICRS) Grade at Months 6 and 12 Month 6: Change value of -1 (n=17, 15, 17, 16)	1 participants	6 participants	3 participants	5 participants
Number of Participants With Change From Baseline in International Cartilage Repair Society (ICRS) Grade at Months 6 and 12 Month 6: Change value of 0 (n=17, 15, 17, 16)	13 participants	5 participants	11 participants	10 participants
Number of Participants With Change From Baseline in International Cartilage Repair Society (ICRS) Grade at Months 6 and 12 Month 6: Change value of 1 (n=17, 15, 17, 16)	3 participants	0 participants	1 participants	1 participants
Number of Participants With Change From Baseline in International Cartilage Repair Society (ICRS) Grade at Months 6 and 12 Month 6: Change value of 2 (n=17, 15, 17, 16)	0 participants	1 participants	1 participants	0 participants
Number of Participants With Change From Baseline in International Cartilage Repair Society (ICRS) Grade at Months 6 and 12 Month 12: Change value of -3 (n=16, 14, 15, 16)	0 participants	1 participants	0 participants	0 participants
Number of Participants With Change From Baseline in International Cartilage Repair Society (ICRS) Grade at Months 6 and 12 Month 12: Change value of -2 (n=16, 14, 15, 16)	0 participants	1 participants	1 participants	0 participants
Number of Participants With Change From Baseline in International Cartilage Repair Society (ICRS) Grade at Months 6 and 12 Month 12: Change value of -1 (n=16, 14, 15, 16)	2 participants	5 participants	3 participants	4 participants
Number of Participants With Change From Baseline in International Cartilage Repair Society (ICRS) Grade at Months 6 and 12 Month 12: Change value of 0 (n=16, 14, 15, 16)	12 participants	6 participants	9 participants	11 participants
Number of Participants With Change From Baseline in International Cartilage Repair Society (ICRS) Grade at Months 6 and 12 Month 12: Change value of 1 (n=16, 14, 15, 16)	2 participants	0 participants	2 participants	1 participants
Number of Participants With Change From Baseline in International Cartilage Repair Society (ICRS) Grade at Months 6 and 12 Month 12: Change value of 2 (n=16, 14, 15, 16)	0 participants	1 participants	0 participants	0 participants

SECONDARY outcome

Timeframe: Baseline, Months 3, 6 and 12

The KOOS is a knee-specific self-administered questionnaire that assesses symptoms and problems associated with knee injury and osteoarthritis. It consists of 42 items grouped into 5 sub-scales: symptoms, pain, function in daily living (FDL), function in sports and recreation activities (FSRA), and quality of life (QoL). Sub-scale scores range from 0-100, with 0 representing extreme knee problems and 100 no knee problems. The IKDC consists of 19 items to summarize symptoms such as highest level of activity without significant pain, frequency and severity of pain scales, stiffness and swelling, highest levels of activity without significant swelling or giving way, knee lock or catch, highest level of activity that can be performed on a regular basis, effect of knee on ability to perform set tasks, knee function prior to injury, and current knee function. The IKDC scores range from 0-100 where high score represents high levels of function.

Outcome measures

Outcome measures
Measure	Sprifermin (AS902330) 10 mcg n=19 Participants Sprifermin (AS902330) was be administered at a dose of 10 microgram (mcg) as intra-articular injection once every week for 3 consecutive weeks.	Sprifermin (AS902330) 30 mcg n=16 Participants Sprifermin (AS902330) was administered at a dose of 30 mcg as intra-articular injection once every week for 3 consecutive weeks.	Sprifermin (AS902330) 100 mcg n=17 Participants Sprifermin (AS902330) was administered at a dose of 100 mcg as intra-articular injection once every week for 3 consecutive weeks.	Placebo n=17 Participants Placebo matched to sprifermin (AS902330) was administered as intra-articular injection once every week for 3 consecutive weeks.
Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Sub-scale Scores and International Knee Documentation Committee (IKDC) Score at Months 3, 6 and 12 KOOS Symptoms: Baseline (n=19, 16, 17, 17)	68.80 units on a scale Standard Deviation 16.955	67.63 units on a scale Standard Deviation 20.432	59.66 units on a scale Standard Deviation 17.024	67.65 units on a scale Standard Deviation 21.297
Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Sub-scale Scores and International Knee Documentation Committee (IKDC) Score at Months 3, 6 and 12 KOOS Symptoms:Change at Month 3(n=19, 16, 17, 17)	14.10 units on a scale Standard Deviation 16.940	12.95 units on a scale Standard Deviation 20.982	21.01 units on a scale Standard Deviation 13.236	17.02 units on a scale Standard Deviation 23.095
Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Sub-scale Scores and International Knee Documentation Committee (IKDC) Score at Months 3, 6 and 12 KOOS Symptoms: Change at Month 6(n=18, 16, 17, 17)	17.26 units on a scale Standard Deviation 18.385	17.19 units on a scale Standard Deviation 16.864	26.47 units on a scale Standard Deviation 11.012	22.27 units on a scale Standard Deviation 23.975
Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Sub-scale Scores and International Knee Documentation Committee (IKDC) Score at Months 3, 6 and 12 KOOS Symptoms: Change at Month 12(n=17, 14, 16,16)	12.61 units on a scale Standard Deviation 20.208	17.86 units on a scale Standard Deviation 17.994	29.91 units on a scale Standard Deviation 14.219	26.12 units on a scale Standard Deviation 23.464
Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Sub-scale Scores and International Knee Documentation Committee (IKDC) Score at Months 3, 6 and 12 KOOS Pain: Baseline (n=19, 16, 17, 17)	65.20 units on a scale Standard Deviation 19.074	67.01 units on a scale Standard Deviation 23.282	56.70 units on a scale Standard Deviation 20.672	65.20 units on a scale Standard Deviation 22.569
Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Sub-scale Scores and International Knee Documentation Committee (IKDC) Score at Months 3, 6 and 12 KOOS Pain: Change at Month 3 (n=19, 16, 17, 17)	16.23 units on a scale Standard Deviation 19.162	18.75 units on a scale Standard Deviation 18.799	24.02 units on a scale Standard Deviation 20.197	24.02 units on a scale Standard Deviation 25.852
Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Sub-scale Scores and International Knee Documentation Committee (IKDC) Score at Months 3, 6 and 12 KOOS Pain: Change at Month 6 (n=18,16,17,17)	19.44 units on a scale Standard Deviation 21.810	22.40 units on a scale Standard Deviation 19.496	26.63 units on a scale Standard Deviation 16.169	27.29 units on a scale Standard Deviation 25.839
Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Sub-scale Scores and International Knee Documentation Committee (IKDC) Score at Months 3, 6 and 12 KOOS Pain: Change at Month 12 (n=17, 14, 16, 16)	16.99 units on a scale Standard Deviation 21.603	18.06 units on a scale Standard Deviation 19.543	31.60 units on a scale Standard Deviation 14.868	28.47 units on a scale Standard Deviation 24.163
Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Sub-scale Scores and International Knee Documentation Committee (IKDC) Score at Months 3, 6 and 12 KOOS FDL: Baseline (n=19, 16, 17, 17)	69.89 units on a scale Standard Deviation 18.053	74.17 units on a scale Standard Deviation 19.969	64.01 units on a scale Standard Deviation 20.694	73.83 units on a scale Standard Deviation 24.326
Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Sub-scale Scores and International Knee Documentation Committee (IKDC) Score at Months 3, 6 and 12 KOOS FDL: Change at Month 3 (n=19, 16, 17, 17)	16.95 units on a scale Standard Deviation 18.630	14.25 units on a scale Standard Deviation 15.809	21.80 units on a scale Standard Deviation 19.302	20.80 units on a scale Standard Deviation 25.123
Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Sub-scale Scores and International Knee Documentation Committee (IKDC) Score at Months 3, 6 and 12 KOOS FDL: Change at Month 6 (n=18, 16, 17, 17)	18.14 units on a scale Standard Deviation 18.690	17.56 units on a scale Standard Deviation 16.883	25.09 units on a scale Standard Deviation 15.637	23.05 units on a scale Standard Deviation 25.792
Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Sub-scale Scores and International Knee Documentation Committee (IKDC) Score at Months 3, 6 and 12 KOOS FDL: Change at Month 12 (n=17, 14, 16, 16)	16.70 units on a scale Standard Deviation 20.370	14.92 units on a scale Standard Deviation 19.199	28.22 units on a scale Standard Deviation 16.183	24.75 units on a scale Standard Deviation 25.689
Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Sub-scale Scores and International Knee Documentation Committee (IKDC) Score at Months 3, 6 and 12 KOOS FSRA: Baseline (n=18, 16, 17, 16)	38.06 units on a scale Standard Deviation 24.920	46.25 units on a scale Standard Deviation 23.488	38.82 units on a scale Standard Deviation 18.416	39.38 units on a scale Standard Deviation 25.747
Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Sub-scale Scores and International Knee Documentation Committee (IKDC) Score at Months 3, 6 and 12 KOOS FSRA: Change at Month 3 (n=18, 16, 17, 16)	22.78 units on a scale Standard Deviation 27.074	25.94 units on a scale Standard Deviation 22.746	27.06 units on a scale Standard Deviation 25.924	38.44 units on a scale Standard Deviation 28.619
Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Sub-scale Scores and International Knee Documentation Committee (IKDC) Score at Months 3, 6 and 12 KOOS FSRA: Change at Month 6 (n=17, 16, 17, 16)	27.94 units on a scale Standard Deviation 26.224	32.19 units on a scale Standard Deviation 23.307	31.47 units on a scale Standard Deviation 23.767	42.81 units on a scale Standard Deviation 29.550
Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Sub-scale Scores and International Knee Documentation Committee (IKDC) Score at Months 3, 6 and 12 KOOS FSRA: Change at Month 12 (n=16, 14, 16, 15)	24.38 units on a scale Standard Deviation 28.336	32.05 units on a scale Standard Deviation 30.070	40.94 units on a scale Standard Deviation 21.926	50.33 units on a scale Standard Deviation 29.669
Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Sub-scale Scores and International Knee Documentation Committee (IKDC) Score at Months 3, 6 and 12 KOOS QoL: Baseline (n=19, 16, 17, 17)	41.45 units on a scale Standard Deviation 25.277	41.41 units on a scale Standard Deviation 14.591	34.19 units on a scale Standard Deviation 15.643	40.07 units on a scale Standard Deviation 19.398
Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Sub-scale Scores and International Knee Documentation Committee (IKDC) Score at Months 3, 6 and 12 KOOS QoL: Change at Month 3 (n=19, 16, 17, 17)	9.54 units on a scale Standard Deviation 24.149	17.19 units on a scale Standard Deviation 18.042	16.54 units on a scale Standard Deviation 23.064	23.16 units on a scale Standard Deviation 25.842
Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Sub-scale Scores and International Knee Documentation Committee (IKDC) Score at Months 3, 6 and 12 KOOS QoL: Change at Month 6 (n=18, 16, 17, 17)	13.89 units on a scale Standard Deviation 26.129	23.44 units on a scale Standard Deviation 20.091	23.53 units on a scale Standard Deviation 17.888	27.94 units on a scale Standard Deviation 28.821
Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Sub-scale Scores and International Knee Documentation Committee (IKDC) Score at Months 3, 6 and 12 KOOS QoL: Change at Month 12 (n=17, 14, 16, 16)	12.13 units on a scale Standard Deviation 27.729	16.52 units on a scale Standard Deviation 23.206	29.69 units on a scale Standard Deviation 17.002	41.41 units on a scale Standard Deviation 28.401
Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Sub-scale Scores and International Knee Documentation Committee (IKDC) Score at Months 3, 6 and 12 IKDC Score: Baseline (n=19, 16, 17, 17)	52.753 units on a scale Standard Deviation 18.8009	50.431 units on a scale Standard Deviation 12.1996	46.045 units on a scale Standard Deviation 15.2838	55.646 units on a scale Standard Deviation 19.0396
Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Sub-scale Scores and International Knee Documentation Committee (IKDC) Score at Months 3, 6 and 12 IKDC Score: Change at Month 3 (n=19, 16, 16, 17)	16.999 units on a scale Standard Deviation 16.6813	23.563 units on a scale Standard Deviation 13.5872	25.790 units on a scale Standard Deviation 19.6412	25.152 units on a scale Standard Deviation 20.1268
Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Sub-scale Scores and International Knee Documentation Committee (IKDC) Score at Months 3, 6 and 12 IKDC Score: Change at Month 6 (n=18, 16, 17, 16)	21.711 units on a scale Standard Deviation 19.4701	28.664 units on a scale Standard Deviation 15.2400	30.494 units on a scale Standard Deviation 18.9965	27.658 units on a scale Standard Deviation 22.8095
Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Sub-scale Scores and International Knee Documentation Committee (IKDC) Score at Months 3, 6 and 12 IKDC Score: Change at Month 12 (n=17, 14, 16, 16)	20.284 units on a scale Standard Deviation 21.2408	25.944 units on a scale Standard Deviation 17.6274	31.787 units on a scale Standard Deviation 19.1616	32.184 units on a scale Standard Deviation 23.3421

SECONDARY outcome

Timeframe: Months 3, 6 and 12

Participants were asked to evaluate and rate the treatment benefit as poor, fair, good, very good or excellent.

Outcome measures

Outcome measures
Measure	Sprifermin (AS902330) 10 mcg n=19 Participants Sprifermin (AS902330) was be administered at a dose of 10 microgram (mcg) as intra-articular injection once every week for 3 consecutive weeks.	Sprifermin (AS902330) 30 mcg n=16 Participants Sprifermin (AS902330) was administered at a dose of 30 mcg as intra-articular injection once every week for 3 consecutive weeks.	Sprifermin (AS902330) 100 mcg n=17 Participants Sprifermin (AS902330) was administered at a dose of 100 mcg as intra-articular injection once every week for 3 consecutive weeks.	Placebo n=17 Participants Placebo matched to sprifermin (AS902330) was administered as intra-articular injection once every week for 3 consecutive weeks.
Number of Participants With Global Evaluation of Treatment Benefit Fair: Month 12 (n= 17, 14, 16, 16)	2 participants	0 participants	0 participants	0 participants
Number of Participants With Global Evaluation of Treatment Benefit Poor: Month 3 (n= 19, 16, 17, 17)	1 participants	1 participants	0 participants	1 participants
Number of Participants With Global Evaluation of Treatment Benefit Fair: Month 3 (n= 19, 16, 17, 17)	3 participants	1 participants	0 participants	3 participants
Number of Participants With Global Evaluation of Treatment Benefit Good: Month 3 (n= 19, 16, 17, 17)	9 participants	6 participants	3 participants	4 participants
Number of Participants With Global Evaluation of Treatment Benefit Very Good: Month 3 (n= 19, 16, 17, 17)	4 participants	5 participants	10 participants	2 participants
Number of Participants With Global Evaluation of Treatment Benefit Excellent: Month 3 (n= 19, 16, 17, 17)	2 participants	3 participants	4 participants	7 participants
Number of Participants With Global Evaluation of Treatment Benefit Poor: Month 6 (n= 18, 16, 17, 17)	0 participants	0 participants	0 participants	1 participants
Number of Participants With Global Evaluation of Treatment Benefit Fair: Month 6 (n= 18, 16, 17, 17)	3 participants	0 participants	0 participants	2 participants
Number of Participants With Global Evaluation of Treatment Benefit Good: Month 6 (n= 18, 16, 17, 17)	7 participants	9 participants	5 participants	6 participants
Number of Participants With Global Evaluation of Treatment Benefit Very Good: Month 6 (n= 18, 16, 17, 17)	5 participants	4 participants	9 participants	2 participants
Number of Participants With Global Evaluation of Treatment Benefit Excellent: Month 6 (n= 18, 16, 17, 17)	3 participants	3 participants	3 participants	6 participants
Number of Participants With Global Evaluation of Treatment Benefit Poor: Month 12 (n= 17, 14, 16, 16)	0 participants	0 participants	0 participants	0 participants
Number of Participants With Global Evaluation of Treatment Benefit Good: Month 12 (n= 17, 14, 16, 16)	6 participants	3 participants	3 participants	6 participants
Number of Participants With Global Evaluation of Treatment Benefit Very Good: Month 12 (n= 17, 14, 16, 16)	7 participants	5 participants	7 participants	6 participants
Number of Participants With Global Evaluation of Treatment Benefit Excellent: Month 12 (n= 17, 14, 16, 16)	2 participants	6 participants	6 participants	4 participants

SECONDARY outcome

Timeframe: Baseline up to Month 12

Population: Safety analysis set included all participants who received at least 1 dose of trial treatment and who had at least 1 post injection safety assessment.

An adverse event (AE) is defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An SAE is an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. TEAEs are those AEs that either started or worsened in severity on or after the date of first dose of study drug and on or before Month 12. Local TEAEs are those only related to the target knee. Systemic TEAEs are those that are related to other parts of the body.

Outcome measures

Outcome measures
Measure	Sprifermin (AS902330) 10 mcg n=19 Participants Sprifermin (AS902330) was be administered at a dose of 10 microgram (mcg) as intra-articular injection once every week for 3 consecutive weeks.	Sprifermin (AS902330) 30 mcg n=18 Participants Sprifermin (AS902330) was administered at a dose of 30 mcg as intra-articular injection once every week for 3 consecutive weeks.	Sprifermin (AS902330) 100 mcg n=18 Participants Sprifermin (AS902330) was administered at a dose of 100 mcg as intra-articular injection once every week for 3 consecutive weeks.	Placebo n=19 Participants Placebo matched to sprifermin (AS902330) was administered as intra-articular injection once every week for 3 consecutive weeks.
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Local TEAEs, Systemic TEAEs, TEAEs Leading to Discontinuation and Serious Adverse Events (SAEs) TEAEs	10 participants	11 participants	12 participants	14 participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Local TEAEs, Systemic TEAEs, TEAEs Leading to Discontinuation and Serious Adverse Events (SAEs) Local TEAEs	9 participants	8 participants	11 participants	11 participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Local TEAEs, Systemic TEAEs, TEAEs Leading to Discontinuation and Serious Adverse Events (SAEs) Systemic TEAEs	6 participants	7 participants	5 participants	7 participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Local TEAEs, Systemic TEAEs, TEAEs Leading to Discontinuation and Serious Adverse Events (SAEs) TEAEs Leading to Discontinuation	0 participants	0 participants	0 participants	1 participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Local TEAEs, Systemic TEAEs, TEAEs Leading to Discontinuation and Serious Adverse Events (SAEs) SAEs	1 participants	0 participants	2 participants	0 participants

SECONDARY outcome

Timeframe: Baseline up to Month 12

Population: Safety analysis set included all participants who received at least 1 dose of trial treatment and who had at least 1 post injection safety assessment. "N" (number of participants analyzed) signifies the participants who were evaluable for this outcome measure.

Acute inflammatory reaction (AIR) is defined as an increase of pain by 30 millimeter (mm) on a 100 mm visual analog scale (VAS) associated with a subject-reported synovial fluid effusion within 3 days following intra-articular injection.

Outcome measures

Outcome measures
Measure	Sprifermin (AS902330) 10 mcg n=14 Participants Sprifermin (AS902330) was be administered at a dose of 10 microgram (mcg) as intra-articular injection once every week for 3 consecutive weeks.	Sprifermin (AS902330) 30 mcg n=14 Participants Sprifermin (AS902330) was administered at a dose of 30 mcg as intra-articular injection once every week for 3 consecutive weeks.	Sprifermin (AS902330) 100 mcg n=15 Participants Sprifermin (AS902330) was administered at a dose of 100 mcg as intra-articular injection once every week for 3 consecutive weeks.	Placebo n=12 Participants Placebo matched to sprifermin (AS902330) was administered as intra-articular injection once every week for 3 consecutive weeks.
Number of Participants With Acute Inflammatory Reactions	4 participants	0 participants	7 participants	2 participants

SECONDARY outcome

Timeframe: Week 1 (pre-dose), Week 2 (pre-dose), Week 4, Months 3 and 12

Population: Safety analysis set included all participants who received at least 1 dose of trial treatment and who had at least 1 post injection safety assessment.

Number of participants with BAbs and NAbs to FGF18 at Week 1 (pre-dose), Week 2 (pre-dose), Week 4, Months 3 and 12 were reported.

Outcome measures

Outcome measures
Measure	Sprifermin (AS902330) 10 mcg n=19 Participants Sprifermin (AS902330) was be administered at a dose of 10 microgram (mcg) as intra-articular injection once every week for 3 consecutive weeks.	Sprifermin (AS902330) 30 mcg n=18 Participants Sprifermin (AS902330) was administered at a dose of 30 mcg as intra-articular injection once every week for 3 consecutive weeks.	Sprifermin (AS902330) 100 mcg n=18 Participants Sprifermin (AS902330) was administered at a dose of 100 mcg as intra-articular injection once every week for 3 consecutive weeks.	Placebo n=19 Participants Placebo matched to sprifermin (AS902330) was administered as intra-articular injection once every week for 3 consecutive weeks.
Number of Participants With Binding Antibodies (BAbs) and Neutralizing Antibodies (NAbs) to Fibroblast Growth Factor 18 (FGF18) NAbs: Week 4	1 participants	2 participants	1 participants	1 participants
Number of Participants With Binding Antibodies (BAbs) and Neutralizing Antibodies (NAbs) to Fibroblast Growth Factor 18 (FGF18) BAbs: Pre-dose Week 1	1 participants	2 participants	1 participants	1 participants
Number of Participants With Binding Antibodies (BAbs) and Neutralizing Antibodies (NAbs) to Fibroblast Growth Factor 18 (FGF18) BAbs: Pre-dose Week 2	1 participants	3 participants	1 participants	1 participants
Number of Participants With Binding Antibodies (BAbs) and Neutralizing Antibodies (NAbs) to Fibroblast Growth Factor 18 (FGF18) BAbs: Week 4	1 participants	3 participants	1 participants	1 participants
Number of Participants With Binding Antibodies (BAbs) and Neutralizing Antibodies (NAbs) to Fibroblast Growth Factor 18 (FGF18) BAbs: Month 3	1 participants	3 participants	0 participants	1 participants
Number of Participants With Binding Antibodies (BAbs) and Neutralizing Antibodies (NAbs) to Fibroblast Growth Factor 18 (FGF18) BAbs: Month 12	1 participants	1 participants	0 participants	1 participants
Number of Participants With Binding Antibodies (BAbs) and Neutralizing Antibodies (NAbs) to Fibroblast Growth Factor 18 (FGF18) NAbs: Pre-dose Week 1	1 participants	1 participants	1 participants	1 participants
Number of Participants With Binding Antibodies (BAbs) and Neutralizing Antibodies (NAbs) to Fibroblast Growth Factor 18 (FGF18) NAbs: Pre-dose Week 2	1 participants	2 participants	1 participants	1 participants
Number of Participants With Binding Antibodies (BAbs) and Neutralizing Antibodies (NAbs) to Fibroblast Growth Factor 18 (FGF18) NAbs: Month 3	1 participants	2 participants	0 participants	1 participants
Number of Participants With Binding Antibodies (BAbs) and Neutralizing Antibodies (NAbs) to Fibroblast Growth Factor 18 (FGF18) NAbs: Month 12	1 participants	0 participants	0 participants	1 participants

Adverse Events

Sprifermin (AS902330) 10 mcg

Serious events: 1 serious events

Other events: 10 other events

Deaths: 0 deaths

Sprifermin (AS902330) 30 mcg

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Sprifermin (AS902330) 100 mcg

Serious events: 2 serious events

Other events: 13 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Sprifermin (AS902330) 10 mcg n=19 participants at risk Sprifermin (AS902330) was administered at a dose of 10 microgram (mcg) as intra-articular injection once every week for 3 consecutive weeks.	Sprifermin (AS902330) 30 mcg n=18 participants at risk Sprifermin (AS902330) was administered at a dose of 30 mcg as intra-articular injection once every week for 3 consecutive weeks.	Sprifermin (AS902330) 100 mcg n=18 participants at risk Sprifermin (AS902330) was administered at a dose of 100 mcg as intra-articular injection once every week for 3 consecutive weeks.	Placebo n=19 participants at risk Placebo matched to sprifermin (AS902330) was administered as intra-articular injection once every week for 3 consecutive weeks.
Reproductive system and breast disorders Menorrhagia	5.3% 1/19 • Baseline Up to Month 12 Safety analysis set included all participants who received at least 1 dose of trial treatment and who had at least 1 post injection safety assessment. One participant randomized to sprifermin (AS902330) 10 mcg group actually received placebo treatment, and therefore was included in placebo group for safety analysis.	0.00% 0/18 • Baseline Up to Month 12 Safety analysis set included all participants who received at least 1 dose of trial treatment and who had at least 1 post injection safety assessment. One participant randomized to sprifermin (AS902330) 10 mcg group actually received placebo treatment, and therefore was included in placebo group for safety analysis.	0.00% 0/18 • Baseline Up to Month 12 Safety analysis set included all participants who received at least 1 dose of trial treatment and who had at least 1 post injection safety assessment. One participant randomized to sprifermin (AS902330) 10 mcg group actually received placebo treatment, and therefore was included in placebo group for safety analysis.	0.00% 0/19 • Baseline Up to Month 12 Safety analysis set included all participants who received at least 1 dose of trial treatment and who had at least 1 post injection safety assessment. One participant randomized to sprifermin (AS902330) 10 mcg group actually received placebo treatment, and therefore was included in placebo group for safety analysis.
Injury, poisoning and procedural complications Joint injury	0.00% 0/19 • Baseline Up to Month 12 Safety analysis set included all participants who received at least 1 dose of trial treatment and who had at least 1 post injection safety assessment. One participant randomized to sprifermin (AS902330) 10 mcg group actually received placebo treatment, and therefore was included in placebo group for safety analysis.	0.00% 0/18 • Baseline Up to Month 12 Safety analysis set included all participants who received at least 1 dose of trial treatment and who had at least 1 post injection safety assessment. One participant randomized to sprifermin (AS902330) 10 mcg group actually received placebo treatment, and therefore was included in placebo group for safety analysis.	5.6% 1/18 • Baseline Up to Month 12 Safety analysis set included all participants who received at least 1 dose of trial treatment and who had at least 1 post injection safety assessment. One participant randomized to sprifermin (AS902330) 10 mcg group actually received placebo treatment, and therefore was included in placebo group for safety analysis.	0.00% 0/19 • Baseline Up to Month 12 Safety analysis set included all participants who received at least 1 dose of trial treatment and who had at least 1 post injection safety assessment. One participant randomized to sprifermin (AS902330) 10 mcg group actually received placebo treatment, and therefore was included in placebo group for safety analysis.
Vascular disorders Hypertension	0.00% 0/19 • Baseline Up to Month 12 Safety analysis set included all participants who received at least 1 dose of trial treatment and who had at least 1 post injection safety assessment. One participant randomized to sprifermin (AS902330) 10 mcg group actually received placebo treatment, and therefore was included in placebo group for safety analysis.	0.00% 0/18 • Baseline Up to Month 12 Safety analysis set included all participants who received at least 1 dose of trial treatment and who had at least 1 post injection safety assessment. One participant randomized to sprifermin (AS902330) 10 mcg group actually received placebo treatment, and therefore was included in placebo group for safety analysis.	5.6% 1/18 • Baseline Up to Month 12 Safety analysis set included all participants who received at least 1 dose of trial treatment and who had at least 1 post injection safety assessment. One participant randomized to sprifermin (AS902330) 10 mcg group actually received placebo treatment, and therefore was included in placebo group for safety analysis.	0.00% 0/19 • Baseline Up to Month 12 Safety analysis set included all participants who received at least 1 dose of trial treatment and who had at least 1 post injection safety assessment. One participant randomized to sprifermin (AS902330) 10 mcg group actually received placebo treatment, and therefore was included in placebo group for safety analysis.

Other adverse events

Additional Information

Merck KGaA Communication Center

Merck Serono, a division of Merck KGaA

Phone: +49-6151-72-5200

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days from the time submitted to the sponsor for review. The sponsor can with reasonable grounds require changes to the communication which do not change the scientific statement or neutrality of the communication.
Publication restrictions are in place

Restriction type: OTHER