Trial Outcomes & Findings for ABX464 in Subjects With Moderate to Severe Active Ulcerative Colitis (NCT NCT03093259)
NCT ID: NCT03093259
Last Updated: 2024-06-03
Results Overview
Number of treatment-emergent adverse events in the ABX464 treated subjects compared to placebo
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
32 participants
Primary outcome timeframe
Week 8
Results posted on
2024-06-03
Participant Flow
Participant milestones
| Measure |
ABX464 Treatment Arm
Subjects will receive 50 mg of ABX464 orally once daily for 56 days.
ABX464: ABX464 is a new Anti-inflammatory drug
|
ABX464 Matching Placebo Treatment Arm
Subjects will receive 50 mg of ABX464 matching Placebo orally once daily for 56 days.
Placebo oral capsule: Placebo matching with ABX464
|
|---|---|---|
|
Overall Study
STARTED
|
23
|
9
|
|
Overall Study
COMPLETED
|
21
|
9
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
ABX464 Treatment Arm
Subjects will receive 50 mg of ABX464 orally once daily for 56 days.
ABX464: ABX464 is a new Anti-inflammatory drug
|
ABX464 Matching Placebo Treatment Arm
Subjects will receive 50 mg of ABX464 matching Placebo orally once daily for 56 days.
Placebo oral capsule: Placebo matching with ABX464
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
ABX464 in Subjects With Moderate to Severe Active Ulcerative Colitis
Baseline characteristics by cohort
| Measure |
ABX464 Treatment Arm
n=23 Participants
Subjects will receive 50 mg of ABX464 orally once daily for 56 days.
ABX464: ABX464 is a new Anti-inflammatory drug
|
ABX464 Matching Placebo Treatment Arm
n=9 Participants
Subjects will receive 50 mg of ABX464 matching Placebo orally once daily for 56 days.
Placebo oral capsule: Placebo matching with ABX464
|
Total
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
19 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
23 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 8Population: All subjects who received at least 1 dose of study treatment
Number of treatment-emergent adverse events in the ABX464 treated subjects compared to placebo
Outcome measures
| Measure |
ABX464 Treatment Arm
n=23 Participants
Subjects will receive 50 mg of ABX464 orally once daily for 56 days.
ABX464: ABX464 is a new Anti-inflammatory drug
|
ABX464 Matching Placebo Treatment Arm
n=9 Participants
Subjects will receive 50 mg of ABX464 matching Placebo orally once daily for 56 days.
Placebo oral capsule: Placebo matching with ABX464
|
|---|---|---|
|
Number of Subjects With Treatment-emergent Adverse Events
|
18 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Week 8Population: Subjects in the FAS without any major protocol deviations and who completed the study (Day 56)
Percentage of subjects receiving ABX464 with clinical remission according to the Total Mayo Score at Week 8 compared to placebo (primary efficacy endpoint)
Outcome measures
| Measure |
ABX464 Treatment Arm
n=20 Participants
Subjects will receive 50 mg of ABX464 orally once daily for 56 days.
ABX464: ABX464 is a new Anti-inflammatory drug
|
ABX464 Matching Placebo Treatment Arm
n=9 Participants
Subjects will receive 50 mg of ABX464 matching Placebo orally once daily for 56 days.
Placebo oral capsule: Placebo matching with ABX464
|
|---|---|---|
|
Clinical Remission
|
7 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Week 8Population: Subjects in the FAS without any major protocol deviations and who completed the study (Day 56)
Percentage of patients with fecal calprotectin levels \> 50µg/g at Week 8 compared to placebo
Outcome measures
| Measure |
ABX464 Treatment Arm
n=20 Participants
Subjects will receive 50 mg of ABX464 orally once daily for 56 days.
ABX464: ABX464 is a new Anti-inflammatory drug
|
ABX464 Matching Placebo Treatment Arm
n=9 Participants
Subjects will receive 50 mg of ABX464 matching Placebo orally once daily for 56 days.
Placebo oral capsule: Placebo matching with ABX464
|
|---|---|---|
|
Fecal Calprotectin
|
15 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: Week 8Population: Subjects in the FAS without any major protocol deviations and who completed the study (Day 56)
Change from baseline in Total Mayo Score in subjects receiving ABX464 compared to placebo. The scale ranges from 0 to 12; 12 being the worst score) - 4-component Scale: Rectal bleeding, Stool frequency, Mucosal appearance and Physician Global Assessment
Outcome measures
| Measure |
ABX464 Treatment Arm
n=20 Participants
Subjects will receive 50 mg of ABX464 orally once daily for 56 days.
ABX464: ABX464 is a new Anti-inflammatory drug
|
ABX464 Matching Placebo Treatment Arm
n=9 Participants
Subjects will receive 50 mg of ABX464 matching Placebo orally once daily for 56 days.
Placebo oral capsule: Placebo matching with ABX464
|
|---|---|---|
|
Total Mayo Score
|
-4.6 score on a scale
Standard Deviation 2.8
|
-2.1 score on a scale
Standard Deviation 2.5
|
SECONDARY outcome
Timeframe: Week 8Population: Subjects in the FAS without any major protocol deviations and who completed the study (Day 56)
Change from baseline in Partial Mayo Score in subjects receiving ABX464 compared to placebo. The scale ranges from 0 to 9, with 9 indicating the worst score. It is a three-component scale assessing rectal bleeding, stool frequency, and the physician's global assessment.
Outcome measures
| Measure |
ABX464 Treatment Arm
n=20 Participants
Subjects will receive 50 mg of ABX464 orally once daily for 56 days.
ABX464: ABX464 is a new Anti-inflammatory drug
|
ABX464 Matching Placebo Treatment Arm
n=9 Participants
Subjects will receive 50 mg of ABX464 matching Placebo orally once daily for 56 days.
Placebo oral capsule: Placebo matching with ABX464
|
|---|---|---|
|
Change in Partial Mayo Score
|
-3.9 units on a scale
Standard Deviation 2.2
|
-1.8 units on a scale
Standard Deviation 2.0
|
Adverse Events
ABX464
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
ABX464
n=23 participants at risk
Participants received 1 oral capsule containing ABX464 daily for 56 days
|
Placebo
n=9 participants at risk
Participants received 1 oral capsule containing placebo daily for 56 days
|
|---|---|---|
|
Renal and urinary disorders
Nephrolithiasis left side
|
0.00%
0/23 • From baseline up to 4 weeks post last dose of study drug (up to 63 Days)
During the study, in case of a safety evaluation, the investigator or site staff will be responsible for reporting AEs and SAEs, as detailed in this section of the protocol. Participants may report AEs occurring at any other time during the study.
|
11.1%
1/9 • Number of events 1 • From baseline up to 4 weeks post last dose of study drug (up to 63 Days)
During the study, in case of a safety evaluation, the investigator or site staff will be responsible for reporting AEs and SAEs, as detailed in this section of the protocol. Participants may report AEs occurring at any other time during the study.
|
Other adverse events
| Measure |
ABX464
n=23 participants at risk
Participants received 1 oral capsule containing ABX464 daily for 56 days
|
Placebo
n=9 participants at risk
Participants received 1 oral capsule containing placebo daily for 56 days
|
|---|---|---|
|
Vascular disorders
Peripheral vascular disorder
|
4.3%
1/23 • From baseline up to 4 weeks post last dose of study drug (up to 63 Days)
During the study, in case of a safety evaluation, the investigator or site staff will be responsible for reporting AEs and SAEs, as detailed in this section of the protocol. Participants may report AEs occurring at any other time during the study.
|
0.00%
0/9 • From baseline up to 4 weeks post last dose of study drug (up to 63 Days)
During the study, in case of a safety evaluation, the investigator or site staff will be responsible for reporting AEs and SAEs, as detailed in this section of the protocol. Participants may report AEs occurring at any other time during the study.
|
|
Gastrointestinal disorders
Abdominal pain
|
17.4%
4/23 • From baseline up to 4 weeks post last dose of study drug (up to 63 Days)
During the study, in case of a safety evaluation, the investigator or site staff will be responsible for reporting AEs and SAEs, as detailed in this section of the protocol. Participants may report AEs occurring at any other time during the study.
|
11.1%
1/9 • From baseline up to 4 weeks post last dose of study drug (up to 63 Days)
During the study, in case of a safety evaluation, the investigator or site staff will be responsible for reporting AEs and SAEs, as detailed in this section of the protocol. Participants may report AEs occurring at any other time during the study.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
13.0%
3/23 • From baseline up to 4 weeks post last dose of study drug (up to 63 Days)
During the study, in case of a safety evaluation, the investigator or site staff will be responsible for reporting AEs and SAEs, as detailed in this section of the protocol. Participants may report AEs occurring at any other time during the study.
|
0.00%
0/9 • From baseline up to 4 weeks post last dose of study drug (up to 63 Days)
During the study, in case of a safety evaluation, the investigator or site staff will be responsible for reporting AEs and SAEs, as detailed in this section of the protocol. Participants may report AEs occurring at any other time during the study.
|
|
Gastrointestinal disorders
Nausea
|
8.7%
2/23 • From baseline up to 4 weeks post last dose of study drug (up to 63 Days)
During the study, in case of a safety evaluation, the investigator or site staff will be responsible for reporting AEs and SAEs, as detailed in this section of the protocol. Participants may report AEs occurring at any other time during the study.
|
0.00%
0/9 • From baseline up to 4 weeks post last dose of study drug (up to 63 Days)
During the study, in case of a safety evaluation, the investigator or site staff will be responsible for reporting AEs and SAEs, as detailed in this section of the protocol. Participants may report AEs occurring at any other time during the study.
|
|
Gastrointestinal disorders
Anal fissure
|
4.3%
1/23 • From baseline up to 4 weeks post last dose of study drug (up to 63 Days)
During the study, in case of a safety evaluation, the investigator or site staff will be responsible for reporting AEs and SAEs, as detailed in this section of the protocol. Participants may report AEs occurring at any other time during the study.
|
0.00%
0/9 • From baseline up to 4 weeks post last dose of study drug (up to 63 Days)
During the study, in case of a safety evaluation, the investigator or site staff will be responsible for reporting AEs and SAEs, as detailed in this section of the protocol. Participants may report AEs occurring at any other time during the study.
|
|
Gastrointestinal disorders
Anorectal discomfort
|
4.3%
1/23 • From baseline up to 4 weeks post last dose of study drug (up to 63 Days)
During the study, in case of a safety evaluation, the investigator or site staff will be responsible for reporting AEs and SAEs, as detailed in this section of the protocol. Participants may report AEs occurring at any other time during the study.
|
0.00%
0/9 • From baseline up to 4 weeks post last dose of study drug (up to 63 Days)
During the study, in case of a safety evaluation, the investigator or site staff will be responsible for reporting AEs and SAEs, as detailed in this section of the protocol. Participants may report AEs occurring at any other time during the study.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/23 • From baseline up to 4 weeks post last dose of study drug (up to 63 Days)
During the study, in case of a safety evaluation, the investigator or site staff will be responsible for reporting AEs and SAEs, as detailed in this section of the protocol. Participants may report AEs occurring at any other time during the study.
|
11.1%
1/9 • From baseline up to 4 weeks post last dose of study drug (up to 63 Days)
During the study, in case of a safety evaluation, the investigator or site staff will be responsible for reporting AEs and SAEs, as detailed in this section of the protocol. Participants may report AEs occurring at any other time during the study.
|
|
Gastrointestinal disorders
Dyspepsia
|
4.3%
1/23 • From baseline up to 4 weeks post last dose of study drug (up to 63 Days)
During the study, in case of a safety evaluation, the investigator or site staff will be responsible for reporting AEs and SAEs, as detailed in this section of the protocol. Participants may report AEs occurring at any other time during the study.
|
0.00%
0/9 • From baseline up to 4 weeks post last dose of study drug (up to 63 Days)
During the study, in case of a safety evaluation, the investigator or site staff will be responsible for reporting AEs and SAEs, as detailed in this section of the protocol. Participants may report AEs occurring at any other time during the study.
|
|
General disorders
Chest pain
|
8.7%
2/23 • From baseline up to 4 weeks post last dose of study drug (up to 63 Days)
During the study, in case of a safety evaluation, the investigator or site staff will be responsible for reporting AEs and SAEs, as detailed in this section of the protocol. Participants may report AEs occurring at any other time during the study.
|
0.00%
0/9 • From baseline up to 4 weeks post last dose of study drug (up to 63 Days)
During the study, in case of a safety evaluation, the investigator or site staff will be responsible for reporting AEs and SAEs, as detailed in this section of the protocol. Participants may report AEs occurring at any other time during the study.
|
|
General disorders
Influenza like illness
|
8.7%
2/23 • From baseline up to 4 weeks post last dose of study drug (up to 63 Days)
During the study, in case of a safety evaluation, the investigator or site staff will be responsible for reporting AEs and SAEs, as detailed in this section of the protocol. Participants may report AEs occurring at any other time during the study.
|
0.00%
0/9 • From baseline up to 4 weeks post last dose of study drug (up to 63 Days)
During the study, in case of a safety evaluation, the investigator or site staff will be responsible for reporting AEs and SAEs, as detailed in this section of the protocol. Participants may report AEs occurring at any other time during the study.
|
|
Infections and infestations
Influenza
|
4.3%
1/23 • From baseline up to 4 weeks post last dose of study drug (up to 63 Days)
During the study, in case of a safety evaluation, the investigator or site staff will be responsible for reporting AEs and SAEs, as detailed in this section of the protocol. Participants may report AEs occurring at any other time during the study.
|
0.00%
0/9 • From baseline up to 4 weeks post last dose of study drug (up to 63 Days)
During the study, in case of a safety evaluation, the investigator or site staff will be responsible for reporting AEs and SAEs, as detailed in this section of the protocol. Participants may report AEs occurring at any other time during the study.
|
|
Infections and infestations
Nasopharyngitis
|
4.3%
1/23 • From baseline up to 4 weeks post last dose of study drug (up to 63 Days)
During the study, in case of a safety evaluation, the investigator or site staff will be responsible for reporting AEs and SAEs, as detailed in this section of the protocol. Participants may report AEs occurring at any other time during the study.
|
11.1%
1/9 • From baseline up to 4 weeks post last dose of study drug (up to 63 Days)
During the study, in case of a safety evaluation, the investigator or site staff will be responsible for reporting AEs and SAEs, as detailed in this section of the protocol. Participants may report AEs occurring at any other time during the study.
|
|
Infections and infestations
Oral herpes
|
4.3%
1/23 • From baseline up to 4 weeks post last dose of study drug (up to 63 Days)
During the study, in case of a safety evaluation, the investigator or site staff will be responsible for reporting AEs and SAEs, as detailed in this section of the protocol. Participants may report AEs occurring at any other time during the study.
|
0.00%
0/9 • From baseline up to 4 weeks post last dose of study drug (up to 63 Days)
During the study, in case of a safety evaluation, the investigator or site staff will be responsible for reporting AEs and SAEs, as detailed in this section of the protocol. Participants may report AEs occurring at any other time during the study.
|
|
Infections and infestations
Rhinitis
|
4.3%
1/23 • From baseline up to 4 weeks post last dose of study drug (up to 63 Days)
During the study, in case of a safety evaluation, the investigator or site staff will be responsible for reporting AEs and SAEs, as detailed in this section of the protocol. Participants may report AEs occurring at any other time during the study.
|
0.00%
0/9 • From baseline up to 4 weeks post last dose of study drug (up to 63 Days)
During the study, in case of a safety evaluation, the investigator or site staff will be responsible for reporting AEs and SAEs, as detailed in this section of the protocol. Participants may report AEs occurring at any other time during the study.
|
|
Infections and infestations
Sinusitis
|
4.3%
1/23 • From baseline up to 4 weeks post last dose of study drug (up to 63 Days)
During the study, in case of a safety evaluation, the investigator or site staff will be responsible for reporting AEs and SAEs, as detailed in this section of the protocol. Participants may report AEs occurring at any other time during the study.
|
0.00%
0/9 • From baseline up to 4 weeks post last dose of study drug (up to 63 Days)
During the study, in case of a safety evaluation, the investigator or site staff will be responsible for reporting AEs and SAEs, as detailed in this section of the protocol. Participants may report AEs occurring at any other time during the study.
|
|
Infections and infestations
Upper respiratory tract infection
|
4.3%
1/23 • From baseline up to 4 weeks post last dose of study drug (up to 63 Days)
During the study, in case of a safety evaluation, the investigator or site staff will be responsible for reporting AEs and SAEs, as detailed in this section of the protocol. Participants may report AEs occurring at any other time during the study.
|
0.00%
0/9 • From baseline up to 4 weeks post last dose of study drug (up to 63 Days)
During the study, in case of a safety evaluation, the investigator or site staff will be responsible for reporting AEs and SAEs, as detailed in this section of the protocol. Participants may report AEs occurring at any other time during the study.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
4.3%
1/23 • From baseline up to 4 weeks post last dose of study drug (up to 63 Days)
During the study, in case of a safety evaluation, the investigator or site staff will be responsible for reporting AEs and SAEs, as detailed in this section of the protocol. Participants may report AEs occurring at any other time during the study.
|
0.00%
0/9 • From baseline up to 4 weeks post last dose of study drug (up to 63 Days)
During the study, in case of a safety evaluation, the investigator or site staff will be responsible for reporting AEs and SAEs, as detailed in this section of the protocol. Participants may report AEs occurring at any other time during the study.
|
|
Investigations
AST/ALT ratio
|
4.3%
1/23 • From baseline up to 4 weeks post last dose of study drug (up to 63 Days)
During the study, in case of a safety evaluation, the investigator or site staff will be responsible for reporting AEs and SAEs, as detailed in this section of the protocol. Participants may report AEs occurring at any other time during the study.
|
0.00%
0/9 • From baseline up to 4 weeks post last dose of study drug (up to 63 Days)
During the study, in case of a safety evaluation, the investigator or site staff will be responsible for reporting AEs and SAEs, as detailed in this section of the protocol. Participants may report AEs occurring at any other time during the study.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
4.3%
1/23 • From baseline up to 4 weeks post last dose of study drug (up to 63 Days)
During the study, in case of a safety evaluation, the investigator or site staff will be responsible for reporting AEs and SAEs, as detailed in this section of the protocol. Participants may report AEs occurring at any other time during the study.
|
22.2%
2/9 • From baseline up to 4 weeks post last dose of study drug (up to 63 Days)
During the study, in case of a safety evaluation, the investigator or site staff will be responsible for reporting AEs and SAEs, as detailed in this section of the protocol. Participants may report AEs occurring at any other time during the study.
|
|
Metabolism and nutrition disorders
Iron deficiency
|
4.3%
1/23 • From baseline up to 4 weeks post last dose of study drug (up to 63 Days)
During the study, in case of a safety evaluation, the investigator or site staff will be responsible for reporting AEs and SAEs, as detailed in this section of the protocol. Participants may report AEs occurring at any other time during the study.
|
11.1%
1/9 • From baseline up to 4 weeks post last dose of study drug (up to 63 Days)
During the study, in case of a safety evaluation, the investigator or site staff will be responsible for reporting AEs and SAEs, as detailed in this section of the protocol. Participants may report AEs occurring at any other time during the study.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.3%
1/23 • From baseline up to 4 weeks post last dose of study drug (up to 63 Days)
During the study, in case of a safety evaluation, the investigator or site staff will be responsible for reporting AEs and SAEs, as detailed in this section of the protocol. Participants may report AEs occurring at any other time during the study.
|
0.00%
0/9 • From baseline up to 4 weeks post last dose of study drug (up to 63 Days)
During the study, in case of a safety evaluation, the investigator or site staff will be responsible for reporting AEs and SAEs, as detailed in this section of the protocol. Participants may report AEs occurring at any other time during the study.
|
|
Nervous system disorders
Headache
|
17.4%
4/23 • From baseline up to 4 weeks post last dose of study drug (up to 63 Days)
During the study, in case of a safety evaluation, the investigator or site staff will be responsible for reporting AEs and SAEs, as detailed in this section of the protocol. Participants may report AEs occurring at any other time during the study.
|
0.00%
0/9 • From baseline up to 4 weeks post last dose of study drug (up to 63 Days)
During the study, in case of a safety evaluation, the investigator or site staff will be responsible for reporting AEs and SAEs, as detailed in this section of the protocol. Participants may report AEs occurring at any other time during the study.
|
|
Nervous system disorders
Poor quality sleep
|
4.3%
1/23 • From baseline up to 4 weeks post last dose of study drug (up to 63 Days)
During the study, in case of a safety evaluation, the investigator or site staff will be responsible for reporting AEs and SAEs, as detailed in this section of the protocol. Participants may report AEs occurring at any other time during the study.
|
0.00%
0/9 • From baseline up to 4 weeks post last dose of study drug (up to 63 Days)
During the study, in case of a safety evaluation, the investigator or site staff will be responsible for reporting AEs and SAEs, as detailed in this section of the protocol. Participants may report AEs occurring at any other time during the study.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/23 • From baseline up to 4 weeks post last dose of study drug (up to 63 Days)
During the study, in case of a safety evaluation, the investigator or site staff will be responsible for reporting AEs and SAEs, as detailed in this section of the protocol. Participants may report AEs occurring at any other time during the study.
|
11.1%
1/9 • From baseline up to 4 weeks post last dose of study drug (up to 63 Days)
During the study, in case of a safety evaluation, the investigator or site staff will be responsible for reporting AEs and SAEs, as detailed in this section of the protocol. Participants may report AEs occurring at any other time during the study.
|
|
Renal and urinary disorders
Renal colic
|
0.00%
0/23 • From baseline up to 4 weeks post last dose of study drug (up to 63 Days)
During the study, in case of a safety evaluation, the investigator or site staff will be responsible for reporting AEs and SAEs, as detailed in this section of the protocol. Participants may report AEs occurring at any other time during the study.
|
11.1%
1/9 • From baseline up to 4 weeks post last dose of study drug (up to 63 Days)
During the study, in case of a safety evaluation, the investigator or site staff will be responsible for reporting AEs and SAEs, as detailed in this section of the protocol. Participants may report AEs occurring at any other time during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
4.3%
1/23 • From baseline up to 4 weeks post last dose of study drug (up to 63 Days)
During the study, in case of a safety evaluation, the investigator or site staff will be responsible for reporting AEs and SAEs, as detailed in this section of the protocol. Participants may report AEs occurring at any other time during the study.
|
0.00%
0/9 • From baseline up to 4 weeks post last dose of study drug (up to 63 Days)
During the study, in case of a safety evaluation, the investigator or site staff will be responsible for reporting AEs and SAEs, as detailed in this section of the protocol. Participants may report AEs occurring at any other time during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
4.3%
1/23 • From baseline up to 4 weeks post last dose of study drug (up to 63 Days)
During the study, in case of a safety evaluation, the investigator or site staff will be responsible for reporting AEs and SAEs, as detailed in this section of the protocol. Participants may report AEs occurring at any other time during the study.
|
0.00%
0/9 • From baseline up to 4 weeks post last dose of study drug (up to 63 Days)
During the study, in case of a safety evaluation, the investigator or site staff will be responsible for reporting AEs and SAEs, as detailed in this section of the protocol. Participants may report AEs occurring at any other time during the study.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
4.3%
1/23 • From baseline up to 4 weeks post last dose of study drug (up to 63 Days)
During the study, in case of a safety evaluation, the investigator or site staff will be responsible for reporting AEs and SAEs, as detailed in this section of the protocol. Participants may report AEs occurring at any other time during the study.
|
0.00%
0/9 • From baseline up to 4 weeks post last dose of study drug (up to 63 Days)
During the study, in case of a safety evaluation, the investigator or site staff will be responsible for reporting AEs and SAEs, as detailed in this section of the protocol. Participants may report AEs occurring at any other time during the study.
|
|
Skin and subcutaneous tissue disorders
Skin discolouration
|
4.3%
1/23 • From baseline up to 4 weeks post last dose of study drug (up to 63 Days)
During the study, in case of a safety evaluation, the investigator or site staff will be responsible for reporting AEs and SAEs, as detailed in this section of the protocol. Participants may report AEs occurring at any other time during the study.
|
0.00%
0/9 • From baseline up to 4 weeks post last dose of study drug (up to 63 Days)
During the study, in case of a safety evaluation, the investigator or site staff will be responsible for reporting AEs and SAEs, as detailed in this section of the protocol. Participants may report AEs occurring at any other time during the study.
|
|
Vascular disorders
Haematoma
|
4.3%
1/23 • From baseline up to 4 weeks post last dose of study drug (up to 63 Days)
During the study, in case of a safety evaluation, the investigator or site staff will be responsible for reporting AEs and SAEs, as detailed in this section of the protocol. Participants may report AEs occurring at any other time during the study.
|
0.00%
0/9 • From baseline up to 4 weeks post last dose of study drug (up to 63 Days)
During the study, in case of a safety evaluation, the investigator or site staff will be responsible for reporting AEs and SAEs, as detailed in this section of the protocol. Participants may report AEs occurring at any other time during the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60