Trial Outcomes & Findings for Clinical Trial to Evaluate the Efficacy and Safety of LEVI-04 in Patients With Osteoarthritis of the Knee (NCT NCT05618782)

NCT ID: NCT05618782

Last Updated: 2025-11-20

Results Overview

The primary efficacy endpoint is the change from baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale score, measured on a 0-10 point scale (0=no pain; 10=worse pain; the result reported is mean change from baseline, therefore the greater the reduction in units the better the outcome)

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 518 participants
• Primary outcome timeframe: Week 17 Change from Baseline
• Results posted on: 2025-11-20

Participant Flow

Participant milestones

Measure	0.3 mg/kg LEVI-04 Intravenous infusion of 0.3 mg/kg LEVI-04	1.0 mg/kg LEVI-04 Intravenous infusion of 1.0 mg/kg LEVI-04	2.0 mg/kg LEVI-04 Intravenous infusion of 2.0 mg/kg LEVI-04	Placebo Intravenous infusion of saline vehicle as placebo
Overall Study STARTED	130	130	129	129
Overall Study COMPLETED	120	121	118	116
Overall Study NOT COMPLETED	10	9	11	13

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Clinical Trial to Evaluate the Efficacy and Safety of LEVI-04 in Patients With Osteoarthritis of the Knee

Baseline characteristics by cohort

Measure	0.3 mg/kg LEVI-04 n=130 Participants Intravenous infusion of 0.3 mg/kg LEVI-04	1.0 mg/kg LEVI-04 n=130 Participants Intravenous infusion of 1.0 mg/kg LEVI-04	2.0 mg/kg LEVI-04 n=129 Participants Intravenous infusion of 2.0 mg/kg LEVI-04	Placebo n=129 Participants Intravenous infusion of saline vehicle as placebo	Total n=518 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants	0 Participants n=4 Participants	0 Participants n=8 Participants	0 Participants n=19 Participants	0 Participants n=254 Participants
Age, Categorical Between 18 and 65 years	68 Participants	55 Participants n=4 Participants	67 Participants n=8 Participants	46 Participants n=19 Participants	236 Participants n=254 Participants
Age, Categorical >=65 years	62 Participants	75 Participants n=4 Participants	62 Participants n=8 Participants	83 Participants n=19 Participants	282 Participants n=254 Participants
Age, Continuous	63.2 years STANDARD_DEVIATION 7.68	64.5 years STANDARD_DEVIATION 8.37 • n=4 Participants	63.1 years STANDARD_DEVIATION 7.80 • n=8 Participants	65.4 years STANDARD_DEVIATION 7.8 • n=19 Participants	64.0 years STANDARD_DEVIATION 8.07 • n=254 Participants
Sex: Female, Male Female	67 Participants	80 Participants n=4 Participants	69 Participants n=8 Participants	76 Participants n=19 Participants	292 Participants n=254 Participants
Sex: Female, Male Male	63 Participants	50 Participants n=4 Participants	60 Participants n=8 Participants	53 Participants n=19 Participants	226 Participants n=254 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants	0 Participants n=4 Participants	0 Participants n=8 Participants	0 Participants n=19 Participants	1 Participants n=254 Participants
Race (NIH/OMB) Asian	12 Participants	15 Participants n=4 Participants	17 Participants n=8 Participants	22 Participants n=19 Participants	66 Participants n=254 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants n=4 Participants	0 Participants n=8 Participants	0 Participants n=19 Participants	0 Participants n=254 Participants
Race (NIH/OMB) Black or African American	0 Participants	0 Participants n=4 Participants	0 Participants n=8 Participants	0 Participants n=19 Participants	0 Participants n=254 Participants
Race (NIH/OMB) White	117 Participants	115 Participants n=4 Participants	112 Participants n=8 Participants	107 Participants n=19 Participants	451 Participants n=254 Participants
Race (NIH/OMB) More than one race	0 Participants	0 Participants n=4 Participants	0 Participants n=8 Participants	0 Participants n=19 Participants	0 Participants n=254 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants n=4 Participants	0 Participants n=8 Participants	0 Participants n=19 Participants	0 Participants n=254 Participants
Region of Enrollment Hong Kong	12 participants	15 participants n=4 Participants	17 participants n=8 Participants	22 participants n=19 Participants	66 participants n=254 Participants
Region of Enrollment Czechia	40 participants	39 participants n=4 Participants	30 participants n=8 Participants	34 participants n=19 Participants	143 participants n=254 Participants
Region of Enrollment Denmark	51 participants	50 participants n=4 Participants	60 participants n=8 Participants	50 participants n=19 Participants	211 participants n=254 Participants
Region of Enrollment Poland	21 participants	24 participants n=4 Participants	16 participants n=8 Participants	20 participants n=19 Participants	81 participants n=254 Participants
Region of Enrollment Moldova	6 participants	2 participants n=4 Participants	6 participants n=8 Participants	3 participants n=19 Participants	17 participants n=254 Participants

PRIMARY outcome

Timeframe: Week 17 Change from Baseline

Population: ITT

The primary efficacy endpoint is the change from baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale score, measured on a 0-10 point scale (0=no pain; 10=worse pain; the result reported is mean change from baseline, therefore the greater the reduction in units the better the outcome)

Outcome measures

Measure	0.3 mg/kg LEVI-04 n=130 Participants Intravenous infusion of 0.3 mg/kg LEVI-04	1.0 mg/kg LEVI-04 n=130 Participants Intravenous infusion of 1.0 mg/kg LEVI-04	2.0 mg/kg LEVI-04 n=129 Participants Intravenous infusion of 2.0 mg/kg LEVI-04	Placebo n=129 Participants Intravenous infusion of saline vehicle as placebo
Least Squares Mean Change From Baseline in WOMAC Pain	-2.77 units on 0-10 point scale Standard Error 0.16	-2.87 units on 0-10 point scale Standard Error 0.17	-3.05 units on 0-10 point scale Standard Error 0.17	-2.26 units on 0-10 point scale Standard Error 0.17

SECONDARY outcome

Timeframe: Week 17 Change from Baseline

Population: ITT

Change from baseline in pain intensity measured following the Staircase Evoked Pain Procedure (StEPP), using a numeric rating scale ranging from 0 to 10 (0=no pain; 10=worse pain; the result reported is mean change from baseline, therefore the greater the reduction in units the better the outcome)

Outcome measures

Measure	0.3 mg/kg LEVI-04 n=111 Participants Intravenous infusion of 0.3 mg/kg LEVI-04	1.0 mg/kg LEVI-04 n=119 Participants Intravenous infusion of 1.0 mg/kg LEVI-04	2.0 mg/kg LEVI-04 n=113 Participants Intravenous infusion of 2.0 mg/kg LEVI-04	Placebo n=110 Participants Intravenous infusion of saline vehicle as placebo
Least Squares Mean Change From Baseline in Post-Staircase Evoked Pain Procedure (StEPP) Pain Intensity	-2.5 units on 0-10 pain scale Standard Error 0.20	-2.6 units on 0-10 pain scale Standard Error 0.19	-3.0 units on 0-10 pain scale Standard Error 0.20	-1.8 units on 0-10 pain scale Standard Error 0.20

SECONDARY outcome

Timeframe: Week 17 Change from Baseline

Population: ITT

Change from baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function subscale, measured on a 0 to 10 point scale (0=no impact on physical function; 10=worse impact on physical function; the result reported is mean change from baseline, therefore the greater the reduction in units the better the outcome)

Outcome measures

Measure	0.3 mg/kg LEVI-04 n=118 Participants Intravenous infusion of 0.3 mg/kg LEVI-04	1.0 mg/kg LEVI-04 n=119 Participants Intravenous infusion of 1.0 mg/kg LEVI-04	2.0 mg/kg LEVI-04 n=116 Participants Intravenous infusion of 2.0 mg/kg LEVI-04	Placebo n=113 Participants Intravenous infusion of saline vehicle as placebo
Least Squares Mean Change From Baseline in WOMAC Physical Function	-2.40 units on 0-10 point scale Standard Error 0.159	-2.49 units on 0-10 point scale Standard Error 0.159	-2.75 units on 0-10 point scale Standard Error 0.162	-1.84 units on 0-10 point scale Standard Error 0.164

SECONDARY outcome

Timeframe: Week 17 Change from Baseline

Population: ITT

Change from baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Joint Stiffness Subscale, scored on a 0 to 10 point scale (0=no stiffness; 10=worst stiffness; the result reported is mean change from baseline, therefore the greater the reduction in units the better the outcome)

Outcome measures

Measure	0.3 mg/kg LEVI-04 n=118 Participants Intravenous infusion of 0.3 mg/kg LEVI-04	1.0 mg/kg LEVI-04 n=119 Participants Intravenous infusion of 1.0 mg/kg LEVI-04	2.0 mg/kg LEVI-04 n=116 Participants Intravenous infusion of 2.0 mg/kg LEVI-04	Placebo n=113 Participants Intravenous infusion of saline vehicle as placebo
Least Squares Mean Change From Baseline in WOMAC Joint Stiffness Subscale	-2.60 units on 0-10 point scale Standard Error 0.179	-2.82 units on 0-10 point scale Standard Error 0.179	-3.20 units on 0-10 point scale Standard Error 0.182	-1.75 units on 0-10 point scale Standard Error 0.185

SECONDARY outcome

Timeframe: Week 17 Change from Baseline

Population: ITT

Change from baseline in the Patient Global Assessment, measured on a 0 to 10 numeric rating scale where 0 indicates "Very good" and 10 indicates "Very bad". The result reported is the mean change from baseline; therefore, the greater the reduction in units, the better the outcome.

Outcome measures

Measure	0.3 mg/kg LEVI-04 n=118 Participants Intravenous infusion of 0.3 mg/kg LEVI-04	1.0 mg/kg LEVI-04 n=119 Participants Intravenous infusion of 1.0 mg/kg LEVI-04	2.0 mg/kg LEVI-04 n=116 Participants Intravenous infusion of 2.0 mg/kg LEVI-04	Placebo n=113 Participants Intravenous infusion of saline vehicle as placebo
Least Squares Mean Change From Baseline in Patient Global Assessment	-2.3 units on 0-10 point scale Standard Error 0.18	-2.6 units on 0-10 point scale Standard Error 0.18	-2.8 units on 0-10 point scale Standard Error 0.19	-1.7 units on 0-10 point scale Standard Error 0.19

Adverse Events

0.3 mg/kg LEVI-04

Serious events: 0 serious events

Other events: 36 other events

Deaths: 0 deaths

1.0 mg/kg LEVI-04

Serious events: 1 serious events

Other events: 44 other events

Deaths: 0 deaths

2.0 mg/kg LEVI-04

Serious events: 3 serious events

Other events: 58 other events

Deaths: 0 deaths

Placebo

Serious events: 3 serious events

Other events: 62 other events

Deaths: 0 deaths

Serious adverse events

Measure	0.3 mg/kg LEVI-04 n=129 participants at risk Intravenous infusion of 0.3 mg/kg LEVI-04	1.0 mg/kg LEVI-04 n=130 participants at risk Intravenous infusion of 1.0 mg/kg LEVI-04	2.0 mg/kg LEVI-04 n=129 participants at risk Intravenous infusion of 2.0 mg/kg LEVI-04	Placebo n=129 participants at risk Intravenous infusion of saline vehicle as placebo
Reproductive system and breast disorders Menstruation irregular	0.00% 0/129 • The AE reporting period for safety surveillance begins when the participant is initially included in the trial (date of signature of ICF) and continues until Week 30 All AEs reported by participants or observed by study personnel from the time of signing the Informed Consent Form through week 30 were documented. Each AE was evaluated for severity using the Qualitative Toxicity Scale, which categorised events as mild, moderate, or severe based on the level of discomfort and impact on the participant's daily activities. Investigators also assessed the relationship between AEs and the IMP, determining whether the event was unrelated or related to the IMP.	0.77% 1/130 • Number of events 1 • The AE reporting period for safety surveillance begins when the participant is initially included in the trial (date of signature of ICF) and continues until Week 30 All AEs reported by participants or observed by study personnel from the time of signing the Informed Consent Form through week 30 were documented. Each AE was evaluated for severity using the Qualitative Toxicity Scale, which categorised events as mild, moderate, or severe based on the level of discomfort and impact on the participant's daily activities. Investigators also assessed the relationship between AEs and the IMP, determining whether the event was unrelated or related to the IMP.	0.00% 0/129 • The AE reporting period for safety surveillance begins when the participant is initially included in the trial (date of signature of ICF) and continues until Week 30 All AEs reported by participants or observed by study personnel from the time of signing the Informed Consent Form through week 30 were documented. Each AE was evaluated for severity using the Qualitative Toxicity Scale, which categorised events as mild, moderate, or severe based on the level of discomfort and impact on the participant's daily activities. Investigators also assessed the relationship between AEs and the IMP, determining whether the event was unrelated or related to the IMP.	0.00% 0/129 • The AE reporting period for safety surveillance begins when the participant is initially included in the trial (date of signature of ICF) and continues until Week 30 All AEs reported by participants or observed by study personnel from the time of signing the Informed Consent Form through week 30 were documented. Each AE was evaluated for severity using the Qualitative Toxicity Scale, which categorised events as mild, moderate, or severe based on the level of discomfort and impact on the participant's daily activities. Investigators also assessed the relationship between AEs and the IMP, determining whether the event was unrelated or related to the IMP.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tongue cancer metastatic	0.00% 0/129 • The AE reporting period for safety surveillance begins when the participant is initially included in the trial (date of signature of ICF) and continues until Week 30 All AEs reported by participants or observed by study personnel from the time of signing the Informed Consent Form through week 30 were documented. Each AE was evaluated for severity using the Qualitative Toxicity Scale, which categorised events as mild, moderate, or severe based on the level of discomfort and impact on the participant's daily activities. Investigators also assessed the relationship between AEs and the IMP, determining whether the event was unrelated or related to the IMP.	0.00% 0/130 • The AE reporting period for safety surveillance begins when the participant is initially included in the trial (date of signature of ICF) and continues until Week 30 All AEs reported by participants or observed by study personnel from the time of signing the Informed Consent Form through week 30 were documented. Each AE was evaluated for severity using the Qualitative Toxicity Scale, which categorised events as mild, moderate, or severe based on the level of discomfort and impact on the participant's daily activities. Investigators also assessed the relationship between AEs and the IMP, determining whether the event was unrelated or related to the IMP.	0.78% 1/129 • Number of events 1 • The AE reporting period for safety surveillance begins when the participant is initially included in the trial (date of signature of ICF) and continues until Week 30 All AEs reported by participants or observed by study personnel from the time of signing the Informed Consent Form through week 30 were documented. Each AE was evaluated for severity using the Qualitative Toxicity Scale, which categorised events as mild, moderate, or severe based on the level of discomfort and impact on the participant's daily activities. Investigators also assessed the relationship between AEs and the IMP, determining whether the event was unrelated or related to the IMP.	0.00% 0/129 • The AE reporting period for safety surveillance begins when the participant is initially included in the trial (date of signature of ICF) and continues until Week 30 All AEs reported by participants or observed by study personnel from the time of signing the Informed Consent Form through week 30 were documented. Each AE was evaluated for severity using the Qualitative Toxicity Scale, which categorised events as mild, moderate, or severe based on the level of discomfort and impact on the participant's daily activities. Investigators also assessed the relationship between AEs and the IMP, determining whether the event was unrelated or related to the IMP.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/129 • The AE reporting period for safety surveillance begins when the participant is initially included in the trial (date of signature of ICF) and continues until Week 30 All AEs reported by participants or observed by study personnel from the time of signing the Informed Consent Form through week 30 were documented. Each AE was evaluated for severity using the Qualitative Toxicity Scale, which categorised events as mild, moderate, or severe based on the level of discomfort and impact on the participant's daily activities. Investigators also assessed the relationship between AEs and the IMP, determining whether the event was unrelated or related to the IMP.	0.00% 0/130 • The AE reporting period for safety surveillance begins when the participant is initially included in the trial (date of signature of ICF) and continues until Week 30 All AEs reported by participants or observed by study personnel from the time of signing the Informed Consent Form through week 30 were documented. Each AE was evaluated for severity using the Qualitative Toxicity Scale, which categorised events as mild, moderate, or severe based on the level of discomfort and impact on the participant's daily activities. Investigators also assessed the relationship between AEs and the IMP, determining whether the event was unrelated or related to the IMP.	0.78% 1/129 • Number of events 1 • The AE reporting period for safety surveillance begins when the participant is initially included in the trial (date of signature of ICF) and continues until Week 30 All AEs reported by participants or observed by study personnel from the time of signing the Informed Consent Form through week 30 were documented. Each AE was evaluated for severity using the Qualitative Toxicity Scale, which categorised events as mild, moderate, or severe based on the level of discomfort and impact on the participant's daily activities. Investigators also assessed the relationship between AEs and the IMP, determining whether the event was unrelated or related to the IMP.	0.00% 0/129 • The AE reporting period for safety surveillance begins when the participant is initially included in the trial (date of signature of ICF) and continues until Week 30 All AEs reported by participants or observed by study personnel from the time of signing the Informed Consent Form through week 30 were documented. Each AE was evaluated for severity using the Qualitative Toxicity Scale, which categorised events as mild, moderate, or severe based on the level of discomfort and impact on the participant's daily activities. Investigators also assessed the relationship between AEs and the IMP, determining whether the event was unrelated or related to the IMP.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/129 • The AE reporting period for safety surveillance begins when the participant is initially included in the trial (date of signature of ICF) and continues until Week 30 All AEs reported by participants or observed by study personnel from the time of signing the Informed Consent Form through week 30 were documented. Each AE was evaluated for severity using the Qualitative Toxicity Scale, which categorised events as mild, moderate, or severe based on the level of discomfort and impact on the participant's daily activities. Investigators also assessed the relationship between AEs and the IMP, determining whether the event was unrelated or related to the IMP.	0.00% 0/130 • The AE reporting period for safety surveillance begins when the participant is initially included in the trial (date of signature of ICF) and continues until Week 30 All AEs reported by participants or observed by study personnel from the time of signing the Informed Consent Form through week 30 were documented. Each AE was evaluated for severity using the Qualitative Toxicity Scale, which categorised events as mild, moderate, or severe based on the level of discomfort and impact on the participant's daily activities. Investigators also assessed the relationship between AEs and the IMP, determining whether the event was unrelated or related to the IMP.	0.78% 1/129 • Number of events 1 • The AE reporting period for safety surveillance begins when the participant is initially included in the trial (date of signature of ICF) and continues until Week 30 All AEs reported by participants or observed by study personnel from the time of signing the Informed Consent Form through week 30 were documented. Each AE was evaluated for severity using the Qualitative Toxicity Scale, which categorised events as mild, moderate, or severe based on the level of discomfort and impact on the participant's daily activities. Investigators also assessed the relationship between AEs and the IMP, determining whether the event was unrelated or related to the IMP.	0.00% 0/129 • The AE reporting period for safety surveillance begins when the participant is initially included in the trial (date of signature of ICF) and continues until Week 30 All AEs reported by participants or observed by study personnel from the time of signing the Informed Consent Form through week 30 were documented. Each AE was evaluated for severity using the Qualitative Toxicity Scale, which categorised events as mild, moderate, or severe based on the level of discomfort and impact on the participant's daily activities. Investigators also assessed the relationship between AEs and the IMP, determining whether the event was unrelated or related to the IMP.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Intraductal proliferative breast lesion	0.00% 0/129 • The AE reporting period for safety surveillance begins when the participant is initially included in the trial (date of signature of ICF) and continues until Week 30 All AEs reported by participants or observed by study personnel from the time of signing the Informed Consent Form through week 30 were documented. Each AE was evaluated for severity using the Qualitative Toxicity Scale, which categorised events as mild, moderate, or severe based on the level of discomfort and impact on the participant's daily activities. Investigators also assessed the relationship between AEs and the IMP, determining whether the event was unrelated or related to the IMP.	0.00% 0/130 • The AE reporting period for safety surveillance begins when the participant is initially included in the trial (date of signature of ICF) and continues until Week 30 All AEs reported by participants or observed by study personnel from the time of signing the Informed Consent Form through week 30 were documented. Each AE was evaluated for severity using the Qualitative Toxicity Scale, which categorised events as mild, moderate, or severe based on the level of discomfort and impact on the participant's daily activities. Investigators also assessed the relationship between AEs and the IMP, determining whether the event was unrelated or related to the IMP.	0.00% 0/129 • The AE reporting period for safety surveillance begins when the participant is initially included in the trial (date of signature of ICF) and continues until Week 30 All AEs reported by participants or observed by study personnel from the time of signing the Informed Consent Form through week 30 were documented. Each AE was evaluated for severity using the Qualitative Toxicity Scale, which categorised events as mild, moderate, or severe based on the level of discomfort and impact on the participant's daily activities. Investigators also assessed the relationship between AEs and the IMP, determining whether the event was unrelated or related to the IMP.	0.78% 1/129 • Number of events 1 • The AE reporting period for safety surveillance begins when the participant is initially included in the trial (date of signature of ICF) and continues until Week 30 All AEs reported by participants or observed by study personnel from the time of signing the Informed Consent Form through week 30 were documented. Each AE was evaluated for severity using the Qualitative Toxicity Scale, which categorised events as mild, moderate, or severe based on the level of discomfort and impact on the participant's daily activities. Investigators also assessed the relationship between AEs and the IMP, determining whether the event was unrelated or related to the IMP.
Injury, poisoning and procedural complications Meniscus injury	0.00% 0/129 • The AE reporting period for safety surveillance begins when the participant is initially included in the trial (date of signature of ICF) and continues until Week 30 All AEs reported by participants or observed by study personnel from the time of signing the Informed Consent Form through week 30 were documented. Each AE was evaluated for severity using the Qualitative Toxicity Scale, which categorised events as mild, moderate, or severe based on the level of discomfort and impact on the participant's daily activities. Investigators also assessed the relationship between AEs and the IMP, determining whether the event was unrelated or related to the IMP.	0.00% 0/130 • The AE reporting period for safety surveillance begins when the participant is initially included in the trial (date of signature of ICF) and continues until Week 30 All AEs reported by participants or observed by study personnel from the time of signing the Informed Consent Form through week 30 were documented. Each AE was evaluated for severity using the Qualitative Toxicity Scale, which categorised events as mild, moderate, or severe based on the level of discomfort and impact on the participant's daily activities. Investigators also assessed the relationship between AEs and the IMP, determining whether the event was unrelated or related to the IMP.	0.00% 0/129 • The AE reporting period for safety surveillance begins when the participant is initially included in the trial (date of signature of ICF) and continues until Week 30 All AEs reported by participants or observed by study personnel from the time of signing the Informed Consent Form through week 30 were documented. Each AE was evaluated for severity using the Qualitative Toxicity Scale, which categorised events as mild, moderate, or severe based on the level of discomfort and impact on the participant's daily activities. Investigators also assessed the relationship between AEs and the IMP, determining whether the event was unrelated or related to the IMP.	0.78% 1/129 • Number of events 1 • The AE reporting period for safety surveillance begins when the participant is initially included in the trial (date of signature of ICF) and continues until Week 30 All AEs reported by participants or observed by study personnel from the time of signing the Informed Consent Form through week 30 were documented. Each AE was evaluated for severity using the Qualitative Toxicity Scale, which categorised events as mild, moderate, or severe based on the level of discomfort and impact on the participant's daily activities. Investigators also assessed the relationship between AEs and the IMP, determining whether the event was unrelated or related to the IMP.
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	0.00% 0/129 • The AE reporting period for safety surveillance begins when the participant is initially included in the trial (date of signature of ICF) and continues until Week 30 All AEs reported by participants or observed by study personnel from the time of signing the Informed Consent Form through week 30 were documented. Each AE was evaluated for severity using the Qualitative Toxicity Scale, which categorised events as mild, moderate, or severe based on the level of discomfort and impact on the participant's daily activities. Investigators also assessed the relationship between AEs and the IMP, determining whether the event was unrelated or related to the IMP.	0.00% 0/130 • The AE reporting period for safety surveillance begins when the participant is initially included in the trial (date of signature of ICF) and continues until Week 30 All AEs reported by participants or observed by study personnel from the time of signing the Informed Consent Form through week 30 were documented. Each AE was evaluated for severity using the Qualitative Toxicity Scale, which categorised events as mild, moderate, or severe based on the level of discomfort and impact on the participant's daily activities. Investigators also assessed the relationship between AEs and the IMP, determining whether the event was unrelated or related to the IMP.	0.00% 0/129 • The AE reporting period for safety surveillance begins when the participant is initially included in the trial (date of signature of ICF) and continues until Week 30 All AEs reported by participants or observed by study personnel from the time of signing the Informed Consent Form through week 30 were documented. Each AE was evaluated for severity using the Qualitative Toxicity Scale, which categorised events as mild, moderate, or severe based on the level of discomfort and impact on the participant's daily activities. Investigators also assessed the relationship between AEs and the IMP, determining whether the event was unrelated or related to the IMP.	0.78% 1/129 • Number of events 1 • The AE reporting period for safety surveillance begins when the participant is initially included in the trial (date of signature of ICF) and continues until Week 30 All AEs reported by participants or observed by study personnel from the time of signing the Informed Consent Form through week 30 were documented. Each AE was evaluated for severity using the Qualitative Toxicity Scale, which categorised events as mild, moderate, or severe based on the level of discomfort and impact on the participant's daily activities. Investigators also assessed the relationship between AEs and the IMP, determining whether the event was unrelated or related to the IMP.

Other adverse events

Measure	0.3 mg/kg LEVI-04 n=129 participants at risk Intravenous infusion of 0.3 mg/kg LEVI-04	1.0 mg/kg LEVI-04 n=130 participants at risk Intravenous infusion of 1.0 mg/kg LEVI-04	2.0 mg/kg LEVI-04 n=129 participants at risk Intravenous infusion of 2.0 mg/kg LEVI-04	Placebo n=129 participants at risk Intravenous infusion of saline vehicle as placebo
Musculoskeletal and connective tissue disorders Arthralgia	8.5% 11/129 • The AE reporting period for safety surveillance begins when the participant is initially included in the trial (date of signature of ICF) and continues until Week 30 All AEs reported by participants or observed by study personnel from the time of signing the Informed Consent Form through week 30 were documented. Each AE was evaluated for severity using the Qualitative Toxicity Scale, which categorised events as mild, moderate, or severe based on the level of discomfort and impact on the participant's daily activities. Investigators also assessed the relationship between AEs and the IMP, determining whether the event was unrelated or related to the IMP.	11.5% 15/130 • The AE reporting period for safety surveillance begins when the participant is initially included in the trial (date of signature of ICF) and continues until Week 30 All AEs reported by participants or observed by study personnel from the time of signing the Informed Consent Form through week 30 were documented. Each AE was evaluated for severity using the Qualitative Toxicity Scale, which categorised events as mild, moderate, or severe based on the level of discomfort and impact on the participant's daily activities. Investigators also assessed the relationship between AEs and the IMP, determining whether the event was unrelated or related to the IMP.	11.6% 15/129 • The AE reporting period for safety surveillance begins when the participant is initially included in the trial (date of signature of ICF) and continues until Week 30 All AEs reported by participants or observed by study personnel from the time of signing the Informed Consent Form through week 30 were documented. Each AE was evaluated for severity using the Qualitative Toxicity Scale, which categorised events as mild, moderate, or severe based on the level of discomfort and impact on the participant's daily activities. Investigators also assessed the relationship between AEs and the IMP, determining whether the event was unrelated or related to the IMP.	15.5% 20/129 • The AE reporting period for safety surveillance begins when the participant is initially included in the trial (date of signature of ICF) and continues until Week 30 All AEs reported by participants or observed by study personnel from the time of signing the Informed Consent Form through week 30 were documented. Each AE was evaluated for severity using the Qualitative Toxicity Scale, which categorised events as mild, moderate, or severe based on the level of discomfort and impact on the participant's daily activities. Investigators also assessed the relationship between AEs and the IMP, determining whether the event was unrelated or related to the IMP.
Infections and infestations Nasopharyngitis	4.7% 6/129 • The AE reporting period for safety surveillance begins when the participant is initially included in the trial (date of signature of ICF) and continues until Week 30 All AEs reported by participants or observed by study personnel from the time of signing the Informed Consent Form through week 30 were documented. Each AE was evaluated for severity using the Qualitative Toxicity Scale, which categorised events as mild, moderate, or severe based on the level of discomfort and impact on the participant's daily activities. Investigators also assessed the relationship between AEs and the IMP, determining whether the event was unrelated or related to the IMP.	6.2% 8/130 • The AE reporting period for safety surveillance begins when the participant is initially included in the trial (date of signature of ICF) and continues until Week 30 All AEs reported by participants or observed by study personnel from the time of signing the Informed Consent Form through week 30 were documented. Each AE was evaluated for severity using the Qualitative Toxicity Scale, which categorised events as mild, moderate, or severe based on the level of discomfort and impact on the participant's daily activities. Investigators also assessed the relationship between AEs and the IMP, determining whether the event was unrelated or related to the IMP.	10.1% 13/129 • The AE reporting period for safety surveillance begins when the participant is initially included in the trial (date of signature of ICF) and continues until Week 30 All AEs reported by participants or observed by study personnel from the time of signing the Informed Consent Form through week 30 were documented. Each AE was evaluated for severity using the Qualitative Toxicity Scale, which categorised events as mild, moderate, or severe based on the level of discomfort and impact on the participant's daily activities. Investigators also assessed the relationship between AEs and the IMP, determining whether the event was unrelated or related to the IMP.	10.1% 13/129 • The AE reporting period for safety surveillance begins when the participant is initially included in the trial (date of signature of ICF) and continues until Week 30 All AEs reported by participants or observed by study personnel from the time of signing the Informed Consent Form through week 30 were documented. Each AE was evaluated for severity using the Qualitative Toxicity Scale, which categorised events as mild, moderate, or severe based on the level of discomfort and impact on the participant's daily activities. Investigators also assessed the relationship between AEs and the IMP, determining whether the event was unrelated or related to the IMP.
Musculoskeletal and connective tissue disorders Back pain	2.3% 3/129 • The AE reporting period for safety surveillance begins when the participant is initially included in the trial (date of signature of ICF) and continues until Week 30 All AEs reported by participants or observed by study personnel from the time of signing the Informed Consent Form through week 30 were documented. Each AE was evaluated for severity using the Qualitative Toxicity Scale, which categorised events as mild, moderate, or severe based on the level of discomfort and impact on the participant's daily activities. Investigators also assessed the relationship between AEs and the IMP, determining whether the event was unrelated or related to the IMP.	3.8% 5/130 • The AE reporting period for safety surveillance begins when the participant is initially included in the trial (date of signature of ICF) and continues until Week 30 All AEs reported by participants or observed by study personnel from the time of signing the Informed Consent Form through week 30 were documented. Each AE was evaluated for severity using the Qualitative Toxicity Scale, which categorised events as mild, moderate, or severe based on the level of discomfort and impact on the participant's daily activities. Investigators also assessed the relationship between AEs and the IMP, determining whether the event was unrelated or related to the IMP.	6.2% 8/129 • The AE reporting period for safety surveillance begins when the participant is initially included in the trial (date of signature of ICF) and continues until Week 30 All AEs reported by participants or observed by study personnel from the time of signing the Informed Consent Form through week 30 were documented. Each AE was evaluated for severity using the Qualitative Toxicity Scale, which categorised events as mild, moderate, or severe based on the level of discomfort and impact on the participant's daily activities. Investigators also assessed the relationship between AEs and the IMP, determining whether the event was unrelated or related to the IMP.	2.3% 3/129 • The AE reporting period for safety surveillance begins when the participant is initially included in the trial (date of signature of ICF) and continues until Week 30 All AEs reported by participants or observed by study personnel from the time of signing the Informed Consent Form through week 30 were documented. Each AE was evaluated for severity using the Qualitative Toxicity Scale, which categorised events as mild, moderate, or severe based on the level of discomfort and impact on the participant's daily activities. Investigators also assessed the relationship between AEs and the IMP, determining whether the event was unrelated or related to the IMP.
Nervous system disorders Headache	3.1% 4/129 • The AE reporting period for safety surveillance begins when the participant is initially included in the trial (date of signature of ICF) and continues until Week 30 All AEs reported by participants or observed by study personnel from the time of signing the Informed Consent Form through week 30 were documented. Each AE was evaluated for severity using the Qualitative Toxicity Scale, which categorised events as mild, moderate, or severe based on the level of discomfort and impact on the participant's daily activities. Investigators also assessed the relationship between AEs and the IMP, determining whether the event was unrelated or related to the IMP.	2.3% 3/130 • The AE reporting period for safety surveillance begins when the participant is initially included in the trial (date of signature of ICF) and continues until Week 30 All AEs reported by participants or observed by study personnel from the time of signing the Informed Consent Form through week 30 were documented. Each AE was evaluated for severity using the Qualitative Toxicity Scale, which categorised events as mild, moderate, or severe based on the level of discomfort and impact on the participant's daily activities. Investigators also assessed the relationship between AEs and the IMP, determining whether the event was unrelated or related to the IMP.	6.2% 8/129 • The AE reporting period for safety surveillance begins when the participant is initially included in the trial (date of signature of ICF) and continues until Week 30 All AEs reported by participants or observed by study personnel from the time of signing the Informed Consent Form through week 30 were documented. Each AE was evaluated for severity using the Qualitative Toxicity Scale, which categorised events as mild, moderate, or severe based on the level of discomfort and impact on the participant's daily activities. Investigators also assessed the relationship between AEs and the IMP, determining whether the event was unrelated or related to the IMP.	4.7% 6/129 • The AE reporting period for safety surveillance begins when the participant is initially included in the trial (date of signature of ICF) and continues until Week 30 All AEs reported by participants or observed by study personnel from the time of signing the Informed Consent Form through week 30 were documented. Each AE was evaluated for severity using the Qualitative Toxicity Scale, which categorised events as mild, moderate, or severe based on the level of discomfort and impact on the participant's daily activities. Investigators also assessed the relationship between AEs and the IMP, determining whether the event was unrelated or related to the IMP.
Infections and infestations Covid-19	3.9% 5/129 • The AE reporting period for safety surveillance begins when the participant is initially included in the trial (date of signature of ICF) and continues until Week 30 All AEs reported by participants or observed by study personnel from the time of signing the Informed Consent Form through week 30 were documented. Each AE was evaluated for severity using the Qualitative Toxicity Scale, which categorised events as mild, moderate, or severe based on the level of discomfort and impact on the participant's daily activities. Investigators also assessed the relationship between AEs and the IMP, determining whether the event was unrelated or related to the IMP.	1.5% 2/130 • The AE reporting period for safety surveillance begins when the participant is initially included in the trial (date of signature of ICF) and continues until Week 30 All AEs reported by participants or observed by study personnel from the time of signing the Informed Consent Form through week 30 were documented. Each AE was evaluated for severity using the Qualitative Toxicity Scale, which categorised events as mild, moderate, or severe based on the level of discomfort and impact on the participant's daily activities. Investigators also assessed the relationship between AEs and the IMP, determining whether the event was unrelated or related to the IMP.	3.1% 4/129 • The AE reporting period for safety surveillance begins when the participant is initially included in the trial (date of signature of ICF) and continues until Week 30 All AEs reported by participants or observed by study personnel from the time of signing the Informed Consent Form through week 30 were documented. Each AE was evaluated for severity using the Qualitative Toxicity Scale, which categorised events as mild, moderate, or severe based on the level of discomfort and impact on the participant's daily activities. Investigators also assessed the relationship between AEs and the IMP, determining whether the event was unrelated or related to the IMP.	6.2% 8/129 • The AE reporting period for safety surveillance begins when the participant is initially included in the trial (date of signature of ICF) and continues until Week 30 All AEs reported by participants or observed by study personnel from the time of signing the Informed Consent Form through week 30 were documented. Each AE was evaluated for severity using the Qualitative Toxicity Scale, which categorised events as mild, moderate, or severe based on the level of discomfort and impact on the participant's daily activities. Investigators also assessed the relationship between AEs and the IMP, determining whether the event was unrelated or related to the IMP.
Infections and infestations Upper respiratory tract infection	3.1% 4/129 • The AE reporting period for safety surveillance begins when the participant is initially included in the trial (date of signature of ICF) and continues until Week 30 All AEs reported by participants or observed by study personnel from the time of signing the Informed Consent Form through week 30 were documented. Each AE was evaluated for severity using the Qualitative Toxicity Scale, which categorised events as mild, moderate, or severe based on the level of discomfort and impact on the participant's daily activities. Investigators also assessed the relationship between AEs and the IMP, determining whether the event was unrelated or related to the IMP.	3.1% 4/130 • The AE reporting period for safety surveillance begins when the participant is initially included in the trial (date of signature of ICF) and continues until Week 30 All AEs reported by participants or observed by study personnel from the time of signing the Informed Consent Form through week 30 were documented. Each AE was evaluated for severity using the Qualitative Toxicity Scale, which categorised events as mild, moderate, or severe based on the level of discomfort and impact on the participant's daily activities. Investigators also assessed the relationship between AEs and the IMP, determining whether the event was unrelated or related to the IMP.	3.9% 5/129 • The AE reporting period for safety surveillance begins when the participant is initially included in the trial (date of signature of ICF) and continues until Week 30 All AEs reported by participants or observed by study personnel from the time of signing the Informed Consent Form through week 30 were documented. Each AE was evaluated for severity using the Qualitative Toxicity Scale, which categorised events as mild, moderate, or severe based on the level of discomfort and impact on the participant's daily activities. Investigators also assessed the relationship between AEs and the IMP, determining whether the event was unrelated or related to the IMP.	5.4% 7/129 • The AE reporting period for safety surveillance begins when the participant is initially included in the trial (date of signature of ICF) and continues until Week 30 All AEs reported by participants or observed by study personnel from the time of signing the Informed Consent Form through week 30 were documented. Each AE was evaluated for severity using the Qualitative Toxicity Scale, which categorised events as mild, moderate, or severe based on the level of discomfort and impact on the participant's daily activities. Investigators also assessed the relationship between AEs and the IMP, determining whether the event was unrelated or related to the IMP.
Musculoskeletal and connective tissue disorders Pain in extremity	2.3% 3/129 • The AE reporting period for safety surveillance begins when the participant is initially included in the trial (date of signature of ICF) and continues until Week 30 All AEs reported by participants or observed by study personnel from the time of signing the Informed Consent Form through week 30 were documented. Each AE was evaluated for severity using the Qualitative Toxicity Scale, which categorised events as mild, moderate, or severe based on the level of discomfort and impact on the participant's daily activities. Investigators also assessed the relationship between AEs and the IMP, determining whether the event was unrelated or related to the IMP.	5.4% 7/130 • The AE reporting period for safety surveillance begins when the participant is initially included in the trial (date of signature of ICF) and continues until Week 30 All AEs reported by participants or observed by study personnel from the time of signing the Informed Consent Form through week 30 were documented. Each AE was evaluated for severity using the Qualitative Toxicity Scale, which categorised events as mild, moderate, or severe based on the level of discomfort and impact on the participant's daily activities. Investigators also assessed the relationship between AEs and the IMP, determining whether the event was unrelated or related to the IMP.	3.9% 5/129 • The AE reporting period for safety surveillance begins when the participant is initially included in the trial (date of signature of ICF) and continues until Week 30 All AEs reported by participants or observed by study personnel from the time of signing the Informed Consent Form through week 30 were documented. Each AE was evaluated for severity using the Qualitative Toxicity Scale, which categorised events as mild, moderate, or severe based on the level of discomfort and impact on the participant's daily activities. Investigators also assessed the relationship between AEs and the IMP, determining whether the event was unrelated or related to the IMP.	3.9% 5/129 • The AE reporting period for safety surveillance begins when the participant is initially included in the trial (date of signature of ICF) and continues until Week 30 All AEs reported by participants or observed by study personnel from the time of signing the Informed Consent Form through week 30 were documented. Each AE was evaluated for severity using the Qualitative Toxicity Scale, which categorised events as mild, moderate, or severe based on the level of discomfort and impact on the participant's daily activities. Investigators also assessed the relationship between AEs and the IMP, determining whether the event was unrelated or related to the IMP.

Additional Information

Iwona Bombelka

Levicept

Phone: 0000000000

Email: info@levicept.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place