Trial Outcomes & Findings for A Six Week Efficacy, Safety and Tolerability Study of V565 in Crohn's Disease (NCT NCT02976129)
NCT ID: NCT02976129
Last Updated: 2021-12-22
Results Overview
Number of responders at Day 42, defined as subjects achieving both CDAI ≥ 70-point reduction from baseline or CDAI score \< 150, and a reduction of ≥ 40% from the baseline value of CRP or FCP. Crohn's Disease Activity Index (CDAI) is used to assess the symptoms of participants with Crohn's Disease. Scores generally range from 0 to 600, where clinical remission of Crohn's disease is defined as CDAI \< 150, and very severe disease is defined as CDAI \> 450.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
125 participants
Primary outcome timeframe
Day 42
Results posted on
2021-12-22
Participant Flow
Participant milestones
| Measure |
V565
V565 three times daily (TID) PO for 6 weeks
V565: Daily dosing of V565 three times a day orally for 6 weeks
|
Placebo
Placebo three times daily (TID) PO for 6 weeks
Placebo: Daily dosing of placebo three times a day orally for 6 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
82
|
43
|
|
Overall Study
COMPLETED
|
77
|
41
|
|
Overall Study
NOT COMPLETED
|
5
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Subjects were recruited into the study if their baseline CRP value was greater than or equal to 5mg/L OR if their baseline faecal calprotectin (FCP) measure was greater than or equal to 250µg/g. Data are reported for only those patients whose baseline CRP was greater than or equal to 5mg/L
Baseline characteristics by cohort
| Measure |
V565
n=82 Participants
V565 TID PO for 6 weeks
V565: Daily dosing of V565 three times a day orally for 6 weeks
|
Placebo
n=43 Participants
Placebo TID PO for 6 weeks
Placebo: Daily dosing of placebo three times a day orally for 6 weeks
|
Total
n=125 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
37.7 years
STANDARD_DEVIATION 14.05 • n=82 Participants
|
37.2 years
STANDARD_DEVIATION 12.08 • n=43 Participants
|
37.5 years
STANDARD_DEVIATION 13.36 • n=125 Participants
|
|
Sex: Female, Male
Female
|
32 Participants
n=82 Participants
|
19 Participants
n=43 Participants
|
51 Participants
n=125 Participants
|
|
Sex: Female, Male
Male
|
50 Participants
n=82 Participants
|
24 Participants
n=43 Participants
|
74 Participants
n=125 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=82 Participants
|
0 Participants
n=43 Participants
|
0 Participants
n=125 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=82 Participants
|
1 Participants
n=43 Participants
|
1 Participants
n=125 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=82 Participants
|
0 Participants
n=43 Participants
|
0 Participants
n=125 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=82 Participants
|
1 Participants
n=43 Participants
|
1 Participants
n=125 Participants
|
|
Race (NIH/OMB)
White
|
82 Participants
n=82 Participants
|
39 Participants
n=43 Participants
|
121 Participants
n=125 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=82 Participants
|
0 Participants
n=43 Participants
|
0 Participants
n=125 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=82 Participants
|
2 Participants
n=43 Participants
|
2 Participants
n=125 Participants
|
|
Region of Enrollment
Hungary
|
4 participants
n=82 Participants
|
1 participants
n=43 Participants
|
5 participants
n=125 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=82 Participants
|
3 participants
n=43 Participants
|
7 participants
n=125 Participants
|
|
Region of Enrollment
Czechia
|
18 participants
n=82 Participants
|
11 participants
n=43 Participants
|
29 participants
n=125 Participants
|
|
Region of Enrollment
Ukraine
|
22 participants
n=82 Participants
|
12 participants
n=43 Participants
|
34 participants
n=125 Participants
|
|
Region of Enrollment
United Kingdom
|
4 participants
n=82 Participants
|
5 participants
n=43 Participants
|
9 participants
n=125 Participants
|
|
Region of Enrollment
Canada
|
1 participants
n=82 Participants
|
1 participants
n=43 Participants
|
2 participants
n=125 Participants
|
|
Region of Enrollment
Austria
|
3 participants
n=82 Participants
|
0 participants
n=43 Participants
|
3 participants
n=125 Participants
|
|
Region of Enrollment
Netherlands
|
1 participants
n=82 Participants
|
0 participants
n=43 Participants
|
1 participants
n=125 Participants
|
|
Region of Enrollment
Norway
|
1 participants
n=82 Participants
|
0 participants
n=43 Participants
|
1 participants
n=125 Participants
|
|
Region of Enrollment
Poland
|
9 participants
n=82 Participants
|
5 participants
n=43 Participants
|
14 participants
n=125 Participants
|
|
Region of Enrollment
Slovakia
|
6 participants
n=82 Participants
|
2 participants
n=43 Participants
|
8 participants
n=125 Participants
|
|
Region of Enrollment
Serbia
|
5 participants
n=82 Participants
|
1 participants
n=43 Participants
|
6 participants
n=125 Participants
|
|
Region of Enrollment
Germany
|
4 participants
n=82 Participants
|
2 participants
n=43 Participants
|
6 participants
n=125 Participants
|
|
Baseline Crohn's Disease Activity Index
|
316.34 units on a scale
STANDARD_DEVIATION 71.283 • n=82 Participants
|
296.69 units on a scale
STANDARD_DEVIATION 64.334 • n=43 Participants
|
309.69 units on a scale
STANDARD_DEVIATION 69.379 • n=125 Participants
|
|
Baseline C-Reactive Protein (CRP)
|
59 mg/L
STANDARD_DEVIATION 21.9 • n=59 Participants • Subjects were recruited into the study if their baseline CRP value was greater than or equal to 5mg/L OR if their baseline faecal calprotectin (FCP) measure was greater than or equal to 250µg/g. Data are reported for only those patients whose baseline CRP was greater than or equal to 5mg/L
|
18.7 mg/L
STANDARD_DEVIATION 14.56 • n=33 Participants • Subjects were recruited into the study if their baseline CRP value was greater than or equal to 5mg/L OR if their baseline faecal calprotectin (FCP) measure was greater than or equal to 250µg/g. Data are reported for only those patients whose baseline CRP was greater than or equal to 5mg/L
|
20.8 mg/L
STANDARD_DEVIATION 17.13 • n=92 Participants • Subjects were recruited into the study if their baseline CRP value was greater than or equal to 5mg/L OR if their baseline faecal calprotectin (FCP) measure was greater than or equal to 250µg/g. Data are reported for only those patients whose baseline CRP was greater than or equal to 5mg/L
|
|
Baseline Faecal Calprotectin (FCP)
|
1082.619 µg/g
STANDARD_DEVIATION 804.2154 • n=23 Participants • Subjects were recruited into the study if their baseline CRP value was greater than or equal to 5mg/L OR if their baseline FCP measure was greater than or equal to 250µg/g. Data are reported for only those patients whose baseline FCP was greater than or equal to 250µg/g
|
1091.217 µg/g
STANDARD_DEVIATION 974.0855 • n=10 Participants • Subjects were recruited into the study if their baseline CRP value was greater than or equal to 5mg/L OR if their baseline FCP measure was greater than or equal to 250µg/g. Data are reported for only those patients whose baseline FCP was greater than or equal to 250µg/g
|
1085.224 µg/g
STANDARD_DEVIATION 843.5207 • n=33 Participants • Subjects were recruited into the study if their baseline CRP value was greater than or equal to 5mg/L OR if their baseline FCP measure was greater than or equal to 250µg/g. Data are reported for only those patients whose baseline FCP was greater than or equal to 250µg/g
|
PRIMARY outcome
Timeframe: Day 42Population: Intent-to-treat population.
Number of responders at Day 42, defined as subjects achieving both CDAI ≥ 70-point reduction from baseline or CDAI score \< 150, and a reduction of ≥ 40% from the baseline value of CRP or FCP. Crohn's Disease Activity Index (CDAI) is used to assess the symptoms of participants with Crohn's Disease. Scores generally range from 0 to 600, where clinical remission of Crohn's disease is defined as CDAI \< 150, and very severe disease is defined as CDAI \> 450.
Outcome measures
| Measure |
V565
n=82 Participants
V565 TID PO for 6 weeks
V565: Daily dosing of V565 three times a day orally for 6 weeks
|
Placebo
n=43 Participants
Placebo TID PO for 6 weeks
Placebo: Daily dosing of placebo three times a day orally for 6 weeks
|
|---|---|---|
|
Number of Subjects Achieving Response to Therapy, Defined as Reduction in the CDAI Score and in Inflammatory Markers CRP or FCP at Day 42.
|
29 Participants
|
16 Participants
|
SECONDARY outcome
Timeframe: Day 42Number of subjects achieving a ≥ 100-point reduction in CDAI score and a concomitant reduction of at least 50% in CRP or FCP at Day 42 Crohn's Disease Activity Index (CDAI) is used to assess the symptoms of participants with Crohn's Disease. Scores generally range from 0 to 600, where clinical remission of Crohn's disease is defined as CDAI \< 150, and very severe disease is defined as CDAI \> 450.
Outcome measures
| Measure |
V565
n=82 Participants
V565 TID PO for 6 weeks
V565: Daily dosing of V565 three times a day orally for 6 weeks
|
Placebo
n=43 Participants
Placebo TID PO for 6 weeks
Placebo: Daily dosing of placebo three times a day orally for 6 weeks
|
|---|---|---|
|
Number of Subjects Achieving Response to Therapy, Defined as Reduction in the CDAI Score and in Inflammatory Markers CRP or FCP at Day 42.
|
20 Participants
|
9 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 42Population: Only those subjects who had a second endoscopy are included in this analysis.
Subjects with a pre-treatment endoscopy Simple Endoscopic Score for Crohn's Disease (SES-CD) of at least 7 (4 if disease was confined to ileum) had a post-treatment endoscopy to evaluate changes in mucosal appearance. The central reader of the endoscopies, blinded to treatment and sequence, was asked to grade if video A was better or worse than video B. Pre- and post-treatment videos were randomly assigned to A and B. The endpoint is the number of subjects whose post-treatment endoscopy was better than their pre-treatment endoscopy.
Outcome measures
| Measure |
V565
n=32 Participants
V565 TID PO for 6 weeks
V565: Daily dosing of V565 three times a day orally for 6 weeks
|
Placebo
n=10 Participants
Placebo TID PO for 6 weeks
Placebo: Daily dosing of placebo three times a day orally for 6 weeks
|
|---|---|---|
|
Number of Subjects With Improvement in Endoscopic Mucosal Appearance
|
18 Participants
|
3 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Days 14 and 42Population: Patients were enrolled into the study based on either a baseline CRP measurement or a baseline FCP measurement. Only the subjects who entered the study based on their CRP measurement are included here.
The number of subjects who entered the study with an elevated CRP who had a CRP level within normal limits at Days 14 and 42. Normal levels defined as CRP less than or equal to 5mg/L
Outcome measures
| Measure |
V565
n=58 Participants
V565 TID PO for 6 weeks
V565: Daily dosing of V565 three times a day orally for 6 weeks
|
Placebo
n=31 Participants
Placebo TID PO for 6 weeks
Placebo: Daily dosing of placebo three times a day orally for 6 weeks
|
|---|---|---|
|
Number of Subjects Achieving CRP Levels Within Normal Limits at Days 14 and 42
|
11 Participants
|
4 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Days 14 and 42Population: Patients were enrolled into the study based on either a baseline CRP measurement or a baseline FCP measurement. Only the subjects who entered the study based on their FCP measurement are included here.
The number of subjects who entered the study with an elevated FCP who had an FCP level within normal limits at Days 14 and 42. Normal limits of FCP defined as less than or equal to 250µg/g
Outcome measures
| Measure |
V565
n=23 Participants
V565 TID PO for 6 weeks
V565: Daily dosing of V565 three times a day orally for 6 weeks
|
Placebo
n=10 Participants
Placebo TID PO for 6 weeks
Placebo: Daily dosing of placebo three times a day orally for 6 weeks
|
|---|---|---|
|
Number of Subjects Achieving FCP Levels Within Normal Limits at Day 14 and 42
|
7 Participants
|
3 Participants
|
Adverse Events
V565
Serious events: 3 serious events
Other events: 30 other events
Deaths: 0 deaths
Placebo
Serious events: 2 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
V565
n=82 participants at risk
V565 TID PO for 6 weeks
V565: Daily dosing of V565 three times a day orally for 6 weeks
|
Placebo
n=43 participants at risk
Placebo TID PO for 6 weeks
Placebo: Daily dosing of placebo three times a day orally for 6 weeks
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
1.2%
1/82 • Number of events 1 • From Day 1 (first day of study medication) to Day 56 (14 days after last dose of study medication)
|
2.3%
1/43 • Number of events 1 • From Day 1 (first day of study medication) to Day 56 (14 days after last dose of study medication)
|
|
Gastrointestinal disorders
Crohns Disease
|
1.2%
1/82 • Number of events 1 • From Day 1 (first day of study medication) to Day 56 (14 days after last dose of study medication)
|
0.00%
0/43 • From Day 1 (first day of study medication) to Day 56 (14 days after last dose of study medication)
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/82 • From Day 1 (first day of study medication) to Day 56 (14 days after last dose of study medication)
|
2.3%
1/43 • Number of events 1 • From Day 1 (first day of study medication) to Day 56 (14 days after last dose of study medication)
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/82 • From Day 1 (first day of study medication) to Day 56 (14 days after last dose of study medication)
|
2.3%
1/43 • Number of events 1 • From Day 1 (first day of study medication) to Day 56 (14 days after last dose of study medication)
|
|
Infections and infestations
Anal abscess
|
1.2%
1/82 • Number of events 1 • From Day 1 (first day of study medication) to Day 56 (14 days after last dose of study medication)
|
0.00%
0/43 • From Day 1 (first day of study medication) to Day 56 (14 days after last dose of study medication)
|
Other adverse events
| Measure |
V565
n=82 participants at risk
V565 TID PO for 6 weeks
V565: Daily dosing of V565 three times a day orally for 6 weeks
|
Placebo
n=43 participants at risk
Placebo TID PO for 6 weeks
Placebo: Daily dosing of placebo three times a day orally for 6 weeks
|
|---|---|---|
|
Investigations
Alanine aminotransferase increased
|
2.4%
2/82 • Number of events 2 • From Day 1 (first day of study medication) to Day 56 (14 days after last dose of study medication)
|
2.3%
1/43 • Number of events 1 • From Day 1 (first day of study medication) to Day 56 (14 days after last dose of study medication)
|
|
Investigations
Aspartate aminotransferase increased
|
2.4%
2/82 • Number of events 2 • From Day 1 (first day of study medication) to Day 56 (14 days after last dose of study medication)
|
0.00%
0/43 • From Day 1 (first day of study medication) to Day 56 (14 days after last dose of study medication)
|
|
Investigations
Urine analysis abnormal
|
0.00%
0/82 • From Day 1 (first day of study medication) to Day 56 (14 days after last dose of study medication)
|
2.3%
1/43 • Number of events 1 • From Day 1 (first day of study medication) to Day 56 (14 days after last dose of study medication)
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/82 • From Day 1 (first day of study medication) to Day 56 (14 days after last dose of study medication)
|
2.3%
1/43 • Number of events 1 • From Day 1 (first day of study medication) to Day 56 (14 days after last dose of study medication)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/82 • From Day 1 (first day of study medication) to Day 56 (14 days after last dose of study medication)
|
2.3%
1/43 • Number of events 1 • From Day 1 (first day of study medication) to Day 56 (14 days after last dose of study medication)
|
|
Blood and lymphatic system disorders
Anaemia
|
1.2%
1/82 • Number of events 1 • From Day 1 (first day of study medication) to Day 56 (14 days after last dose of study medication)
|
2.3%
1/43 • Number of events 1 • From Day 1 (first day of study medication) to Day 56 (14 days after last dose of study medication)
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/82 • From Day 1 (first day of study medication) to Day 56 (14 days after last dose of study medication)
|
2.3%
1/43 • Number of events 1 • From Day 1 (first day of study medication) to Day 56 (14 days after last dose of study medication)
|
|
Blood and lymphatic system disorders
Neutrophilia
|
0.00%
0/82 • From Day 1 (first day of study medication) to Day 56 (14 days after last dose of study medication)
|
2.3%
1/43 • Number of events 1 • From Day 1 (first day of study medication) to Day 56 (14 days after last dose of study medication)
|
|
Nervous system disorders
Headache
|
1.2%
1/82 • Number of events 1 • From Day 1 (first day of study medication) to Day 56 (14 days after last dose of study medication)
|
2.3%
1/43 • Number of events 1 • From Day 1 (first day of study medication) to Day 56 (14 days after last dose of study medication)
|
|
Nervous system disorders
Seizure
|
0.00%
0/82 • From Day 1 (first day of study medication) to Day 56 (14 days after last dose of study medication)
|
2.3%
1/43 • Number of events 1 • From Day 1 (first day of study medication) to Day 56 (14 days after last dose of study medication)
|
|
General disorders
Oedema peripheral
|
0.00%
0/82 • From Day 1 (first day of study medication) to Day 56 (14 days after last dose of study medication)
|
2.3%
1/43 • Number of events 1 • From Day 1 (first day of study medication) to Day 56 (14 days after last dose of study medication)
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/82 • From Day 1 (first day of study medication) to Day 56 (14 days after last dose of study medication)
|
2.3%
1/43 • Number of events 1 • From Day 1 (first day of study medication) to Day 56 (14 days after last dose of study medication)
|
|
Psychiatric disorders
Personality change
|
0.00%
0/82 • From Day 1 (first day of study medication) to Day 56 (14 days after last dose of study medication)
|
2.3%
1/43 • Number of events 1 • From Day 1 (first day of study medication) to Day 56 (14 days after last dose of study medication)
|
|
Gastrointestinal disorders
Abdominal pain
|
4.9%
4/82 • Number of events 6 • From Day 1 (first day of study medication) to Day 56 (14 days after last dose of study medication)
|
9.3%
4/43 • Number of events 4 • From Day 1 (first day of study medication) to Day 56 (14 days after last dose of study medication)
|
|
Gastrointestinal disorders
Crohn's Disease
|
6.1%
5/82 • Number of events 5 • From Day 1 (first day of study medication) to Day 56 (14 days after last dose of study medication)
|
0.00%
0/43 • From Day 1 (first day of study medication) to Day 56 (14 days after last dose of study medication)
|
|
Gastrointestinal disorders
Diarrhoea
|
2.4%
2/82 • Number of events 2 • From Day 1 (first day of study medication) to Day 56 (14 days after last dose of study medication)
|
4.7%
2/43 • Number of events 2 • From Day 1 (first day of study medication) to Day 56 (14 days after last dose of study medication)
|
|
Gastrointestinal disorders
Vomiting
|
1.2%
1/82 • Number of events 1 • From Day 1 (first day of study medication) to Day 56 (14 days after last dose of study medication)
|
4.7%
2/43 • Number of events 2 • From Day 1 (first day of study medication) to Day 56 (14 days after last dose of study medication)
|
|
Gastrointestinal disorders
Dyspepsia
|
2.4%
2/82 • Number of events 2 • From Day 1 (first day of study medication) to Day 56 (14 days after last dose of study medication)
|
0.00%
0/43 • From Day 1 (first day of study medication) to Day 56 (14 days after last dose of study medication)
|
|
Gastrointestinal disorders
Nausea
|
2.4%
2/82 • Number of events 2 • From Day 1 (first day of study medication) to Day 56 (14 days after last dose of study medication)
|
0.00%
0/43 • From Day 1 (first day of study medication) to Day 56 (14 days after last dose of study medication)
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/82 • From Day 1 (first day of study medication) to Day 56 (14 days after last dose of study medication)
|
2.3%
1/43 • Number of events 1 • From Day 1 (first day of study medication) to Day 56 (14 days after last dose of study medication)
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/82 • From Day 1 (first day of study medication) to Day 56 (14 days after last dose of study medication)
|
2.3%
1/43 • Number of events 1 • From Day 1 (first day of study medication) to Day 56 (14 days after last dose of study medication)
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/82 • From Day 1 (first day of study medication) to Day 56 (14 days after last dose of study medication)
|
2.3%
1/43 • Number of events 1 • From Day 1 (first day of study medication) to Day 56 (14 days after last dose of study medication)
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/82 • From Day 1 (first day of study medication) to Day 56 (14 days after last dose of study medication)
|
2.3%
1/43 • Number of events 1 • From Day 1 (first day of study medication) to Day 56 (14 days after last dose of study medication)
|
|
Renal and urinary disorders
Pollakiuria
|
1.2%
1/82 • Number of events 1 • From Day 1 (first day of study medication) to Day 56 (14 days after last dose of study medication)
|
2.3%
1/43 • Number of events 1 • From Day 1 (first day of study medication) to Day 56 (14 days after last dose of study medication)
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/82 • From Day 1 (first day of study medication) to Day 56 (14 days after last dose of study medication)
|
2.3%
1/43 • Number of events 1 • From Day 1 (first day of study medication) to Day 56 (14 days after last dose of study medication)
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/82 • From Day 1 (first day of study medication) to Day 56 (14 days after last dose of study medication)
|
2.3%
1/43 • Number of events 1 • From Day 1 (first day of study medication) to Day 56 (14 days after last dose of study medication)
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
1.2%
1/82 • Number of events 1 • From Day 1 (first day of study medication) to Day 56 (14 days after last dose of study medication)
|
2.3%
1/43 • Number of events 1 • From Day 1 (first day of study medication) to Day 56 (14 days after last dose of study medication)
|
|
Infections and infestations
Anal abscess
|
2.4%
2/82 • Number of events 2 • From Day 1 (first day of study medication) to Day 56 (14 days after last dose of study medication)
|
0.00%
0/43 • From Day 1 (first day of study medication) to Day 56 (14 days after last dose of study medication)
|
|
Infections and infestations
Gastroenteritis
|
2.4%
2/82 • Number of events 2 • From Day 1 (first day of study medication) to Day 56 (14 days after last dose of study medication)
|
0.00%
0/43 • From Day 1 (first day of study medication) to Day 56 (14 days after last dose of study medication)
|
|
Infections and infestations
Influenza
|
2.4%
2/82 • Number of events 3 • From Day 1 (first day of study medication) to Day 56 (14 days after last dose of study medication)
|
0.00%
0/43 • From Day 1 (first day of study medication) to Day 56 (14 days after last dose of study medication)
|
|
Infections and infestations
Pulpitis dental
|
2.4%
2/82 • Number of events 2 • From Day 1 (first day of study medication) to Day 56 (14 days after last dose of study medication)
|
0.00%
0/43 • From Day 1 (first day of study medication) to Day 56 (14 days after last dose of study medication)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60