Trial Outcomes & Findings for A Study of the Safety, Tolerability and Efficacy of Treatment With AP1189 in Early RA Patients With Active Joint Disease (NCT NCT04004429)
NCT ID: NCT04004429
Last Updated: 2024-07-10
Results Overview
The change in CDAI from severe (CDAI \> 22) to moderate (CDAI \<= 22) after 4 weeks treatment compared to baseline. CDAI is calculated as a sum of: * SJC (28): Number of Swollen 28-Joint Count (shoulders, elbows, wrists, MCPs, PIPs including thumb IP, knees); * TJC (28): Number of Tender 28-Joint Count (shoulders, elbows, wrists, MCPs, PIPs including thumb IP, knees) * PGA: Patient Global Disease Activity (patient's self-assessment of overall RA disease activity on a scale 0-100, where 100 is maximal activity) * IGA: Physician's Global Disease Activity (evaluator's assessment of the subject's overall RA disease activity on a scale 0-100, where 100 is maximal activity)
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
105 participants
Primary outcome timeframe
4 weeks
Results posted on
2024-07-10
Participant Flow
Participant milestones
| Measure |
50 mg AP1189
50 mg AP1189. The treatment is a 4 week treatment. Each daily dose will be administered as a suspension, i e. the powder will be added 50 ml water.
50 mg AP1189: 50 mg AP1189 powder in bottle
|
100 mg AP1189
100 mg AP1189. The treatment is a 4 week treatment. Each daily dose will be administered as a suspension, i e. the powder will be added 50 ml water.
AP1189: 100 mg AP1189 powder in bottle
|
Placebo
Placebo. The treatment is a 4 week treatment. Each daily dose will be administered as a suspension i e. the powder will be added 50 ml water.
Placebo: Placebo powder in bottle
|
|---|---|---|---|
|
Overall Study
STARTED
|
35
|
36
|
34
|
|
Overall Study
COMPLETED
|
33
|
34
|
32
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
2
|
Reasons for withdrawal
| Measure |
50 mg AP1189
50 mg AP1189. The treatment is a 4 week treatment. Each daily dose will be administered as a suspension, i e. the powder will be added 50 ml water.
50 mg AP1189: 50 mg AP1189 powder in bottle
|
100 mg AP1189
100 mg AP1189. The treatment is a 4 week treatment. Each daily dose will be administered as a suspension, i e. the powder will be added 50 ml water.
AP1189: 100 mg AP1189 powder in bottle
|
Placebo
Placebo. The treatment is a 4 week treatment. Each daily dose will be administered as a suspension i e. the powder will be added 50 ml water.
Placebo: Placebo powder in bottle
|
|---|---|---|---|
|
Overall Study
Protocol Violation
|
1
|
0
|
0
|
|
Overall Study
Physician Decision
|
0
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
1
|
Baseline Characteristics
A Study of the Safety, Tolerability and Efficacy of Treatment With AP1189 in Early RA Patients With Active Joint Disease
Baseline characteristics by cohort
| Measure |
50 mg AP1189
n=35 Participants
50 mg AP1189. The treatment is a 4 week treatment. Each daily dose will be administered as a suspension, i e. the powder will be added 50 ml water.
50 mg AP1189: 50 mg AP1189 powder in bottle
|
100 mg AP1189
n=36 Participants
100 mg AP1189. The treatment is a 4 week treatment. Each daily dose will be administered as a suspension, i e. the powder will be added 50 ml water.
AP1189: 100 mg AP1189 powder in bottle
|
Placebo
n=34 Participants
Placebo. The treatment is a 4 week treatment. Each daily dose will be administered as a suspension i e. the powder will be added 50 ml water.
Placebo: Placebo powder in bottle
|
Total
n=105 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
25 Participants
n=93 Participants
|
26 Participants
n=4 Participants
|
25 Participants
n=27 Participants
|
76 Participants
n=483 Participants
|
|
Age, Categorical
>=65 years
|
10 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
29 Participants
n=483 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=93 Participants
|
28 Participants
n=4 Participants
|
27 Participants
n=27 Participants
|
82 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
23 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
35 Participants
n=93 Participants
|
36 Participants
n=4 Participants
|
32 Participants
n=27 Participants
|
103 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Region of Enrollment
Norway
|
2 participants
n=93 Participants
|
0 participants
n=4 Participants
|
1 participants
n=27 Participants
|
3 participants
n=483 Participants
|
|
Region of Enrollment
Denmark
|
13 participants
n=93 Participants
|
15 participants
n=4 Participants
|
15 participants
n=27 Participants
|
43 participants
n=483 Participants
|
|
Region of Enrollment
Sweden
|
3 participants
n=93 Participants
|
3 participants
n=4 Participants
|
1 participants
n=27 Participants
|
7 participants
n=483 Participants
|
|
Region of Enrollment
Moldova
|
8 participants
n=93 Participants
|
6 participants
n=4 Participants
|
7 participants
n=27 Participants
|
21 participants
n=483 Participants
|
|
Region of Enrollment
Bulgaria
|
9 participants
n=93 Participants
|
12 participants
n=4 Participants
|
10 participants
n=27 Participants
|
31 participants
n=483 Participants
|
PRIMARY outcome
Timeframe: 4 weeksPopulation: The number of participants analyzed differs from the overall number of participants. Participants that received rescue medication during the treatment period was excluded from the analyses.
The change in CDAI from severe (CDAI \> 22) to moderate (CDAI \<= 22) after 4 weeks treatment compared to baseline. CDAI is calculated as a sum of: * SJC (28): Number of Swollen 28-Joint Count (shoulders, elbows, wrists, MCPs, PIPs including thumb IP, knees); * TJC (28): Number of Tender 28-Joint Count (shoulders, elbows, wrists, MCPs, PIPs including thumb IP, knees) * PGA: Patient Global Disease Activity (patient's self-assessment of overall RA disease activity on a scale 0-100, where 100 is maximal activity) * IGA: Physician's Global Disease Activity (evaluator's assessment of the subject's overall RA disease activity on a scale 0-100, where 100 is maximal activity)
Outcome measures
| Measure |
50 mg AP1189
n=29 Participants
50 mg AP1189. The treatment is a 4 week treatment. Each daily dose will be administered as a suspension, i e. the powder will be added 50 ml water.
50 mg AP1189: 50 mg AP1189 powder in bottle
|
100 mg AP1189
n=33 Participants
100 mg AP1189. The treatment is a 4 week treatment. Each daily dose will be administered as a suspension, i e. the powder will be added 50 ml water.
AP1189: 100 mg AP1189 powder in bottle
|
Placebo
n=30 Participants
Placebo. The treatment is a 4 week treatment. Each daily dose will be administered as a suspension i e. the powder will be added 50 ml water.
Placebo: Placebo powder in bottle
|
|---|---|---|---|
|
Change in Clinical Disease Activity Index (CDAI)
|
18 Participants
|
17 Participants
|
12 Participants
|
PRIMARY outcome
Timeframe: 4 weeksPopulation: The number of participants analyzed differs from the overall number of participants. Participants that received rescue medication during the treatment period was excluded from the analyses.
The change in CDAI after 4 weeks treatment compared to baseline. CDAI is calculated as a sum of: * SJC (28): Number of Swollen 28-Joint Count (shoulders, elbows, wrists, MCPs, PIPs including thumb IP, knees); * TJC (28): Number of Tender 28-Joint Count (shoulders, elbows, wrists, MCPs, PIPs including thumb IP, knees) * PGA: Patient Global Disease Activity (patient's self-assessment of overall RA disease activity on a scale 0-100, where 100 is maximal activity) * IGA: Physician's Global Disease Activity (evaluator's assessment of the subject's overall RA disease activity on a scale 0-100, where 100 is maximal activity). The CDAI score range is from 0 - 76, whereas a score of: ≤2.8 means Remission \>2.8 and ≤10 means Low Disease Activity \>10 and ≤22 means Moderate Disease Activity \>22 means High Disease Activity For the purpose of this study, a decrease in CDAI (improvement) is reported as - xx.xx).
Outcome measures
| Measure |
50 mg AP1189
n=29 Participants
50 mg AP1189. The treatment is a 4 week treatment. Each daily dose will be administered as a suspension, i e. the powder will be added 50 ml water.
50 mg AP1189: 50 mg AP1189 powder in bottle
|
100 mg AP1189
n=33 Participants
100 mg AP1189. The treatment is a 4 week treatment. Each daily dose will be administered as a suspension, i e. the powder will be added 50 ml water.
AP1189: 100 mg AP1189 powder in bottle
|
Placebo
n=30 Participants
Placebo. The treatment is a 4 week treatment. Each daily dose will be administered as a suspension i e. the powder will be added 50 ml water.
Placebo: Placebo powder in bottle
|
|---|---|---|---|
|
Change in Clinical Disease Activity Index (CDAI)
|
-11.97 Calculated score
Standard Deviation 8.74
|
-15.52 Calculated score
Standard Deviation 12.70
|
-9.33 Calculated score
Standard Deviation 10.58
|
SECONDARY outcome
Timeframe: 4 weeksPopulation: The number of participants analyzed differs from the overall number of participants. Participants that received rescue medication during the treatment period was excluded from the analyses.
Proportion of subjects achieving a response assessed by ACR20. The ACR response rate ACR20 is defined as ≥20% improvement in swollen and tender joint counts (SJC/TJC) and 3 of the following 5 assessments: Patient's Global Assessment of Disease Activity, Physician's Global Assessment of Disease Activity, Patient's Assessment of Pain, Health Assessment Questionnaire - Disability Index or C-Reactive Protein. Proportion in the context of this protocol refers to number of participants.
Outcome measures
| Measure |
50 mg AP1189
n=29 Participants
50 mg AP1189. The treatment is a 4 week treatment. Each daily dose will be administered as a suspension, i e. the powder will be added 50 ml water.
50 mg AP1189: 50 mg AP1189 powder in bottle
|
100 mg AP1189
n=33 Participants
100 mg AP1189. The treatment is a 4 week treatment. Each daily dose will be administered as a suspension, i e. the powder will be added 50 ml water.
AP1189: 100 mg AP1189 powder in bottle
|
Placebo
n=30 Participants
Placebo. The treatment is a 4 week treatment. Each daily dose will be administered as a suspension i e. the powder will be added 50 ml water.
Placebo: Placebo powder in bottle
|
|---|---|---|---|
|
ACR (American College of Rheumatology) Response
|
11 Participants
|
20 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: 4 weeksPopulation: The number of participants analyzed differs from the overall number of participants. Participants that received rescue medication during the treatment period was excluded from the analyses.
Proportion of subjects achieving a response assessed by ACR50. The ACR response rate ACR50 is defined as ≥50% improvement in swollen and tender joint counts (SJC/TJC) and 3 of the following 5 assessments: Patient's Global Assessment of Disease Activity, Physician's Global Assessment of Disease Activity, Patient's Assessment of Pain, Health Assessment Questionnaire - Disability Index or C-Reactive Protein. Proportion in the context of this protocol refers to number of participants.
Outcome measures
| Measure |
50 mg AP1189
n=29 Participants
50 mg AP1189. The treatment is a 4 week treatment. Each daily dose will be administered as a suspension, i e. the powder will be added 50 ml water.
50 mg AP1189: 50 mg AP1189 powder in bottle
|
100 mg AP1189
n=33 Participants
100 mg AP1189. The treatment is a 4 week treatment. Each daily dose will be administered as a suspension, i e. the powder will be added 50 ml water.
AP1189: 100 mg AP1189 powder in bottle
|
Placebo
n=30 Participants
Placebo. The treatment is a 4 week treatment. Each daily dose will be administered as a suspension i e. the powder will be added 50 ml water.
Placebo: Placebo powder in bottle
|
|---|---|---|---|
|
ACR (American College of Rheumatology) Response
|
2 Participants
|
8 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: 4 weeksPopulation: The number of participants analyzed differs from the overall number of participants. Participants that received rescue medication during the treatment period was excluded from the analyses.
Proportion of subjects achieving a response assessed by ACR70. The ACR response rate ACR70 is defined as ≥70% improvement in swollen and tender joint counts (SJC/TJC) and 3 of the following 5 assessments: Patient's Global Assessment of Disease Activity, Physician's Global Assessment of Disease Activity, Patient's Assessment of Pain, Health Assessment Questionnaire - Disability Index or C-Reactive Protein. Proportion in the context of this protocol refers to number of participants.
Outcome measures
| Measure |
50 mg AP1189
n=29 Participants
50 mg AP1189. The treatment is a 4 week treatment. Each daily dose will be administered as a suspension, i e. the powder will be added 50 ml water.
50 mg AP1189: 50 mg AP1189 powder in bottle
|
100 mg AP1189
n=33 Participants
100 mg AP1189. The treatment is a 4 week treatment. Each daily dose will be administered as a suspension, i e. the powder will be added 50 ml water.
AP1189: 100 mg AP1189 powder in bottle
|
Placebo
n=30 Participants
Placebo. The treatment is a 4 week treatment. Each daily dose will be administered as a suspension i e. the powder will be added 50 ml water.
Placebo: Placebo powder in bottle
|
|---|---|---|---|
|
ACR (American College of Rheumatology) Response
|
0 Participants
|
4 Participants
|
1 Participants
|
Adverse Events
50 mg AP1189
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
100 mg AP1189
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
50 mg AP1189
n=35 participants at risk
50 mg AP1189. The treatment is a 4 week treatment. Each daily dose will be administered as a suspension, i e. the powder will be added 50 ml water.
50 mg AP1189: 50 mg AP1189 powder in bottle
|
100 mg AP1189
n=36 participants at risk
100 mg AP1189. The treatment is a 4 week treatment. Each daily dose will be administered as a suspension, i e. the powder will be added 50 ml water.
AP1189: 100 mg AP1189 powder in bottle
|
Placebo
n=34 participants at risk
Placebo. The treatment is a 4 week treatment. Each daily dose will be administered as a suspension i e. the powder will be added 50 ml water.
Placebo: Placebo powder in bottle
|
|---|---|---|---|
|
Investigations
Alanine aminotransferase increased
|
17.1%
6/35 • Number of events 6 • All Adverse Event (AE)s were collected starting from the time of signed informed consent and until the final visit (End of Study/Early Termination visit) had occurred. Any AE that was ongoing at the final visit was followed until resolution or until four weeks after the study drug administration, whichever came first.
|
0.00%
0/36 • All Adverse Event (AE)s were collected starting from the time of signed informed consent and until the final visit (End of Study/Early Termination visit) had occurred. Any AE that was ongoing at the final visit was followed until resolution or until four weeks after the study drug administration, whichever came first.
|
8.8%
3/34 • Number of events 3 • All Adverse Event (AE)s were collected starting from the time of signed informed consent and until the final visit (End of Study/Early Termination visit) had occurred. Any AE that was ongoing at the final visit was followed until resolution or until four weeks after the study drug administration, whichever came first.
|
|
Blood and lymphatic system disorders
Anemia
|
5.7%
2/35 • Number of events 2 • All Adverse Event (AE)s were collected starting from the time of signed informed consent and until the final visit (End of Study/Early Termination visit) had occurred. Any AE that was ongoing at the final visit was followed until resolution or until four weeks after the study drug administration, whichever came first.
|
2.8%
1/36 • Number of events 1 • All Adverse Event (AE)s were collected starting from the time of signed informed consent and until the final visit (End of Study/Early Termination visit) had occurred. Any AE that was ongoing at the final visit was followed until resolution or until four weeks after the study drug administration, whichever came first.
|
2.9%
1/34 • Number of events 1 • All Adverse Event (AE)s were collected starting from the time of signed informed consent and until the final visit (End of Study/Early Termination visit) had occurred. Any AE that was ongoing at the final visit was followed until resolution or until four weeks after the study drug administration, whichever came first.
|
|
Musculoskeletal and connective tissue disorders
Arthritis rheumatoid aggravated
|
8.6%
3/35 • Number of events 4 • All Adverse Event (AE)s were collected starting from the time of signed informed consent and until the final visit (End of Study/Early Termination visit) had occurred. Any AE that was ongoing at the final visit was followed until resolution or until four weeks after the study drug administration, whichever came first.
|
5.6%
2/36 • Number of events 4 • All Adverse Event (AE)s were collected starting from the time of signed informed consent and until the final visit (End of Study/Early Termination visit) had occurred. Any AE that was ongoing at the final visit was followed until resolution or until four weeks after the study drug administration, whichever came first.
|
2.9%
1/34 • Number of events 1 • All Adverse Event (AE)s were collected starting from the time of signed informed consent and until the final visit (End of Study/Early Termination visit) had occurred. Any AE that was ongoing at the final visit was followed until resolution or until four weeks after the study drug administration, whichever came first.
|
|
Investigations
Aspartate aminotransferase increased
|
5.7%
2/35 • Number of events 2 • All Adverse Event (AE)s were collected starting from the time of signed informed consent and until the final visit (End of Study/Early Termination visit) had occurred. Any AE that was ongoing at the final visit was followed until resolution or until four weeks after the study drug administration, whichever came first.
|
0.00%
0/36 • All Adverse Event (AE)s were collected starting from the time of signed informed consent and until the final visit (End of Study/Early Termination visit) had occurred. Any AE that was ongoing at the final visit was followed until resolution or until four weeks after the study drug administration, whichever came first.
|
5.9%
2/34 • Number of events 2 • All Adverse Event (AE)s were collected starting from the time of signed informed consent and until the final visit (End of Study/Early Termination visit) had occurred. Any AE that was ongoing at the final visit was followed until resolution or until four weeks after the study drug administration, whichever came first.
|
|
Gastrointestinal disorders
Constipation
|
5.7%
2/35 • Number of events 2 • All Adverse Event (AE)s were collected starting from the time of signed informed consent and until the final visit (End of Study/Early Termination visit) had occurred. Any AE that was ongoing at the final visit was followed until resolution or until four weeks after the study drug administration, whichever came first.
|
8.3%
3/36 • Number of events 3 • All Adverse Event (AE)s were collected starting from the time of signed informed consent and until the final visit (End of Study/Early Termination visit) had occurred. Any AE that was ongoing at the final visit was followed until resolution or until four weeks after the study drug administration, whichever came first.
|
0.00%
0/34 • All Adverse Event (AE)s were collected starting from the time of signed informed consent and until the final visit (End of Study/Early Termination visit) had occurred. Any AE that was ongoing at the final visit was followed until resolution or until four weeks after the study drug administration, whichever came first.
|
|
Investigations
Diarrhea
|
2.9%
1/35 • Number of events 1 • All Adverse Event (AE)s were collected starting from the time of signed informed consent and until the final visit (End of Study/Early Termination visit) had occurred. Any AE that was ongoing at the final visit was followed until resolution or until four weeks after the study drug administration, whichever came first.
|
5.6%
2/36 • Number of events 2 • All Adverse Event (AE)s were collected starting from the time of signed informed consent and until the final visit (End of Study/Early Termination visit) had occurred. Any AE that was ongoing at the final visit was followed until resolution or until four weeks after the study drug administration, whichever came first.
|
0.00%
0/34 • All Adverse Event (AE)s were collected starting from the time of signed informed consent and until the final visit (End of Study/Early Termination visit) had occurred. Any AE that was ongoing at the final visit was followed until resolution or until four weeks after the study drug administration, whichever came first.
|
|
Investigations
GGT increased
|
8.6%
3/35 • Number of events 3 • All Adverse Event (AE)s were collected starting from the time of signed informed consent and until the final visit (End of Study/Early Termination visit) had occurred. Any AE that was ongoing at the final visit was followed until resolution or until four weeks after the study drug administration, whichever came first.
|
0.00%
0/36 • All Adverse Event (AE)s were collected starting from the time of signed informed consent and until the final visit (End of Study/Early Termination visit) had occurred. Any AE that was ongoing at the final visit was followed until resolution or until four weeks after the study drug administration, whichever came first.
|
8.8%
3/34 • Number of events 3 • All Adverse Event (AE)s were collected starting from the time of signed informed consent and until the final visit (End of Study/Early Termination visit) had occurred. Any AE that was ongoing at the final visit was followed until resolution or until four weeks after the study drug administration, whichever came first.
|
|
Nervous system disorders
Headache
|
5.7%
2/35 • Number of events 2 • All Adverse Event (AE)s were collected starting from the time of signed informed consent and until the final visit (End of Study/Early Termination visit) had occurred. Any AE that was ongoing at the final visit was followed until resolution or until four weeks after the study drug administration, whichever came first.
|
13.9%
5/36 • Number of events 5 • All Adverse Event (AE)s were collected starting from the time of signed informed consent and until the final visit (End of Study/Early Termination visit) had occurred. Any AE that was ongoing at the final visit was followed until resolution or until four weeks after the study drug administration, whichever came first.
|
0.00%
0/34 • All Adverse Event (AE)s were collected starting from the time of signed informed consent and until the final visit (End of Study/Early Termination visit) had occurred. Any AE that was ongoing at the final visit was followed until resolution or until four weeks after the study drug administration, whichever came first.
|
|
Gastrointestinal disorders
Nausea
|
14.3%
5/35 • Number of events 5 • All Adverse Event (AE)s were collected starting from the time of signed informed consent and until the final visit (End of Study/Early Termination visit) had occurred. Any AE that was ongoing at the final visit was followed until resolution or until four weeks after the study drug administration, whichever came first.
|
19.4%
7/36 • Number of events 8 • All Adverse Event (AE)s were collected starting from the time of signed informed consent and until the final visit (End of Study/Early Termination visit) had occurred. Any AE that was ongoing at the final visit was followed until resolution or until four weeks after the study drug administration, whichever came first.
|
20.6%
7/34 • Number of events 7 • All Adverse Event (AE)s were collected starting from the time of signed informed consent and until the final visit (End of Study/Early Termination visit) had occurred. Any AE that was ongoing at the final visit was followed until resolution or until four weeks after the study drug administration, whichever came first.
|
|
Gastrointestinal disorders
Obstipation
|
5.7%
2/35 • Number of events 2 • All Adverse Event (AE)s were collected starting from the time of signed informed consent and until the final visit (End of Study/Early Termination visit) had occurred. Any AE that was ongoing at the final visit was followed until resolution or until four weeks after the study drug administration, whichever came first.
|
2.8%
1/36 • Number of events 1 • All Adverse Event (AE)s were collected starting from the time of signed informed consent and until the final visit (End of Study/Early Termination visit) had occurred. Any AE that was ongoing at the final visit was followed until resolution or until four weeks after the study drug administration, whichever came first.
|
0.00%
0/34 • All Adverse Event (AE)s were collected starting from the time of signed informed consent and until the final visit (End of Study/Early Termination visit) had occurred. Any AE that was ongoing at the final visit was followed until resolution or until four weeks after the study drug administration, whichever came first.
|
|
Respiratory, thoracic and mediastinal disorders
Sore Throat
|
0.00%
0/35 • All Adverse Event (AE)s were collected starting from the time of signed informed consent and until the final visit (End of Study/Early Termination visit) had occurred. Any AE that was ongoing at the final visit was followed until resolution or until four weeks after the study drug administration, whichever came first.
|
5.6%
2/36 • Number of events 2 • All Adverse Event (AE)s were collected starting from the time of signed informed consent and until the final visit (End of Study/Early Termination visit) had occurred. Any AE that was ongoing at the final visit was followed until resolution or until four weeks after the study drug administration, whichever came first.
|
2.9%
1/34 • Number of events 1 • All Adverse Event (AE)s were collected starting from the time of signed informed consent and until the final visit (End of Study/Early Termination visit) had occurred. Any AE that was ongoing at the final visit was followed until resolution or until four weeks after the study drug administration, whichever came first.
|
Additional Information
Thomas Jonassen, Chief Scientific Officer
SynAct Pharma
Phone: +45 4015 6669
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60