Trial Outcomes & Findings for Efficacy&Safety of ALTB-168 in Patients With Moderate to Severe Active,Anti-TNF Alpha and/or Anti-integrin Refractory UC (NCT NCT03298022)
NCT ID: NCT03298022
Last Updated: 2024-01-05
Results Overview
The clinical response is defined as a ≥ 3-point reduction in Mayo Clinic Score, a 30% or greater decrease from the baseline score, and with a 1-point or greater decrease of the rectal bleeding subscore or an absolute rectal bleeding score of 0 or 1, The colonic site with maximum inflammation was determined by Mayo endoscopic subscore (MES) defined as follows: normal (0 points); erythema, decreased vascular pattern, mild friability (1 point); absent vascular pattern, friability, erosions (2 points); and spontaneous bleeding or ulceration (3 points). Lower score means disease improvement.
TERMINATED
PHASE2
24 participants
week 12
2024-01-05
Participant Flow
Participants were enrolled at 12 centers locate in North America and Puerto Rico from May 2018 to June 2020. It was a 24 weeks open label, single arm, multiple dose proof of principle study.
Participant milestones
| Measure |
ALTB-168 in Patients With Refractory Ulcerative Colitis
Amendment 1\~3: 9 mg/kg; total of 8 doses of ALTB-168. Amendment 4: 9 mg/kg; total of 10 doses of ALTB-168.
|
|---|---|
|
Overall Study
STARTED
|
24
|
|
Overall Study
Number of Participants Who Received 8 Doses of ALTB-168
|
10
|
|
Overall Study
Number of Participants Who Received 10 Doses of ALTB-168
|
14
|
|
Overall Study
COMPLETED
|
11
|
|
Overall Study
NOT COMPLETED
|
13
|
Reasons for withdrawal
| Measure |
ALTB-168 in Patients With Refractory Ulcerative Colitis
Amendment 1\~3: 9 mg/kg; total of 8 doses of ALTB-168. Amendment 4: 9 mg/kg; total of 10 doses of ALTB-168.
|
|---|---|
|
Overall Study
Lack of Efficacy
|
4
|
|
Overall Study
Withdrawal by Subject
|
7
|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
disease relapse
|
1
|
Baseline Characteristics
Total enrolled number of participants is 24. 10 participants were enrolled under Amendment 1-3 14 participants were enrolled under Amendment 4
Baseline characteristics by cohort
| Measure |
ALTB-168
n=24 Participants
Intravenous doses of ALTB-168
ALTB-168: monoclonal antibody
|
|---|---|
|
Age, Categorical
Enrolled Under Amendment 1-3 · <=18 years
|
0 Participants
n=10 Participants • Total enrolled number of participants is 24. 10 participants were enrolled under Amendment 1-3 14 participants were enrolled under Amendment 4
|
|
Age, Categorical
Enrolled Under Amendment 1-3 · Between 18 and 65 years
|
9 Participants
n=10 Participants • Total enrolled number of participants is 24. 10 participants were enrolled under Amendment 1-3 14 participants were enrolled under Amendment 4
|
|
Age, Categorical
Enrolled Under Amendment 1-3 · >=65 years
|
1 Participants
n=10 Participants • Total enrolled number of participants is 24. 10 participants were enrolled under Amendment 1-3 14 participants were enrolled under Amendment 4
|
|
Age, Categorical
Enrolled Under Amendment 4 · <=18 years
|
0 Participants
n=14 Participants • Total enrolled number of participants is 24. 10 participants were enrolled under Amendment 1-3 14 participants were enrolled under Amendment 4
|
|
Age, Categorical
Enrolled Under Amendment 4 · Between 18 and 65 years
|
14 Participants
n=14 Participants • Total enrolled number of participants is 24. 10 participants were enrolled under Amendment 1-3 14 participants were enrolled under Amendment 4
|
|
Age, Categorical
Enrolled Under Amendment 4 · >=65 years
|
0 Participants
n=14 Participants • Total enrolled number of participants is 24. 10 participants were enrolled under Amendment 1-3 14 participants were enrolled under Amendment 4
|
|
Age, Continuous
Amendment 1-3
|
37 years
n=10 Participants • 10 subjects were enrolled under Amendment 1-3 and 14 subjects under Amendment 4.
|
|
Age, Continuous
Amendment 4
|
35.5 years
n=14 Participants • 10 subjects were enrolled under Amendment 1-3 and 14 subjects under Amendment 4.
|
|
Sex: Female, Male
Enrolled under Amendment 1~3 · Female
|
6 Participants
n=10 Participants • Row population does not differ from the Overall population. Altogether 24 participants were enrolled to the study. Out of them 10 were enrolled under protocol Amendments 1-3 and 14 under the Amendment 14.
|
|
Sex: Female, Male
Enrolled under Amendment 1~3 · Male
|
4 Participants
n=10 Participants • Row population does not differ from the Overall population. Altogether 24 participants were enrolled to the study. Out of them 10 were enrolled under protocol Amendments 1-3 and 14 under the Amendment 14.
|
|
Sex: Female, Male
Enrolled under Amendment 4 · Female
|
7 Participants
n=14 Participants • Row population does not differ from the Overall population. Altogether 24 participants were enrolled to the study. Out of them 10 were enrolled under protocol Amendments 1-3 and 14 under the Amendment 14.
|
|
Sex: Female, Male
Enrolled under Amendment 4 · Male
|
7 Participants
n=14 Participants • Row population does not differ from the Overall population. Altogether 24 participants were enrolled to the study. Out of them 10 were enrolled under protocol Amendments 1-3 and 14 under the Amendment 14.
|
|
Race/Ethnicity, Customized
Ethnicity · Hispanic or Latino
|
7 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Not Hispanic or Latino
|
15 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Not reported
|
2 Participants
n=24 Participants
|
|
Region of Enrollment
United States
|
24 participants
n=24 Participants
|
PRIMARY outcome
Timeframe: week 12Population: The full analysis set includes all participants who received at least 1 dose of study drug. The response rates were calculated using non-responder imputation, where participants with a missing scores at week 12 were counted as non-responders.
The clinical response is defined as a ≥ 3-point reduction in Mayo Clinic Score, a 30% or greater decrease from the baseline score, and with a 1-point or greater decrease of the rectal bleeding subscore or an absolute rectal bleeding score of 0 or 1, The colonic site with maximum inflammation was determined by Mayo endoscopic subscore (MES) defined as follows: normal (0 points); erythema, decreased vascular pattern, mild friability (1 point); absent vascular pattern, friability, erosions (2 points); and spontaneous bleeding or ulceration (3 points). Lower score means disease improvement.
Outcome measures
| Measure |
Pilot Study (Amendment 1~3: 9 mg/kg; Total 8 Doses)
n=9 Participants
10 participants enrolled under protocol Amendments 1-3 received total of 8 doses of ALTB-168
|
Main Study (Amendment 4: 9 mg/kg; Total 10 Doses)
n=14 Participants
14 participants enrolled under Amendment 4 received total of 10 doses of ALTB-168
|
|---|---|---|
|
The Proportion of Patients With Clinical Response at Week 12
|
22.2 percentage of total number of patients
Interval 2.8 to 60.0
|
50 percentage of total number of patients
Interval 23.0 to 77.0
|
SECONDARY outcome
Timeframe: weeks 6,16, 20 and 26Population: The full analysis set includes all participants who received at least 1 dose of study drug. Response rates were calculated using non-responder imputation, where participants with a missing information were counted as non-responders. 23 participants are included in the study analysis. 9 participants from the pilot study (protocol Amendments 1-3) and 14 participants from the main study (protocol Amendment 4).
The proportion of patients with clinical response defined as a ≥2-point decrease in partial MCS (pMCS), and with a 1 point or greater decrease of the rectal bleeding subscale or an absolute rectal bleeding score of 0 or 1. The colonic site with maximum inflammation was determined by Mayo endoscopic subscore (MES) defined as follows: normal (0 points); erythema, decreased vascular pattern, mild friability (1 point); absent vascular pattern, friability, erosions (2 points); and spontaneous bleeding or ulceration (3 points). Lower score means disease improvement.
Outcome measures
| Measure |
Pilot Study (Amendment 1~3: 9 mg/kg; Total 8 Doses)
n=9 Participants
10 participants enrolled under protocol Amendments 1-3 received total of 8 doses of ALTB-168
|
Main Study (Amendment 4: 9 mg/kg; Total 10 Doses)
n=14 Participants
14 participants enrolled under Amendment 4 received total of 10 doses of ALTB-168
|
|---|---|---|
|
The Proportion of Patients With Clinical Response (mITT)
Clinical Response at week 6
|
33.3 percentage of total number of patients
Interval 7.5 to 70.1
|
57.1 percentage of total number of patients
Interval 28.9 to 82.3
|
|
The Proportion of Patients With Clinical Response (mITT)
Clinical Response at week 16
|
0 percentage of total number of patients
Interval 0.0 to 0.0
|
64.3 percentage of total number of patients
Interval 35.1 to 87.2
|
|
The Proportion of Patients With Clinical Response (mITT)
Clinical Response at week 20
|
11.1 percentage of total number of patients
Interval 0.3 to 48.2
|
64.3 percentage of total number of patients
Interval 35.1 to 87.2
|
|
The Proportion of Patients With Clinical Response (mITT)
Clinical Response at week 26
|
11.1 percentage of total number of patients
Interval 0.3 to 48.2
|
35.7 percentage of total number of patients
Interval 12.8 to 64.9
|
SECONDARY outcome
Timeframe: weeks 6,16, 20 and 26Population: The full analysis set includes all participants who received at least 1 dose of study drug. Response rates were calculated using non-responder imputation, where participants with a missing information were counted as non-responders. 23 participants are included in the study analysis. 9 participants from the pilot study (protocol Amendments 1-3) and 14 participants from the main study (protocol Amendment 4).
The number of patients with clinical remission, defined as MCS of 2 or lower (or pMCS of 1 or lower) and no subscore higher than 1. The colonic site with maximum inflammation was determined by Mayo endoscopic subscore (MES) defined as follows: normal (0 points); erythema, decreased vascular pattern, mild friability (1 point); absent vascular pattern, friability, erosions (2 points); and spontaneous bleeding or ulceration (3 points). Lower score means disease improvement.
Outcome measures
| Measure |
Pilot Study (Amendment 1~3: 9 mg/kg; Total 8 Doses)
n=9 Participants
10 participants enrolled under protocol Amendments 1-3 received total of 8 doses of ALTB-168
|
Main Study (Amendment 4: 9 mg/kg; Total 10 Doses)
n=14 Participants
14 participants enrolled under Amendment 4 received total of 10 doses of ALTB-168
|
|---|---|---|
|
The Proportion of Patients With Clinical Remission
Clinical response at week 6
|
11.1 percentage of total number of patients
Interval 0.3 to 48.2
|
35.7 percentage of total number of patients
Interval 12.8 to 64.9
|
|
The Proportion of Patients With Clinical Remission
Clinical response at week 16
|
0 percentage of total number of patients
Interval 0.0 to 0.0
|
35.7 percentage of total number of patients
Interval 12.8 to 64.9
|
|
The Proportion of Patients With Clinical Remission
Clinical response at week 20
|
0 percentage of total number of patients
Interval 0.0 to 0.0
|
35.7 percentage of total number of patients
Interval 12.8 to 64.9
|
|
The Proportion of Patients With Clinical Remission
Clinical response at week 26
|
11.1 percentage of total number of patients
Interval 0.3 to 48.2
|
21.4 percentage of total number of patients
Interval 4.7 to 50.8
|
SECONDARY outcome
Timeframe: Baseline, week 12- and week 26 after the first treatmentPopulation: Study participants who entered the study under amendment 1-3 (n=9) and participans who entered the study under amendment 4 (n=14) have been inlcuded in this analysis
The mean (SD) observed flexible sigmoidoscopy subscore change from baseline (CFB). Baseline is defined as the last available assessment prior to the first administration of the study drug. The sigmoidoscopic improvement is defined as any decrease in Mayo Clinic Score (MCS) endoscopic subscore, at Weeks 12 and 26. MCS range is 1-3. The colonic site with maximum inflammation was determined by Mayo endoscopic subscore (MES) defined as follows: normal (0 points); erythema, decreased vascular pattern, mild friability (1 point); absent vascular pattern, friability, erosions (2 points); and spontaneous bleeding or ulceration (3 points). Lower score means disease improvement.
Outcome measures
| Measure |
Pilot Study (Amendment 1~3: 9 mg/kg; Total 8 Doses)
n=9 Participants
10 participants enrolled under protocol Amendments 1-3 received total of 8 doses of ALTB-168
|
Main Study (Amendment 4: 9 mg/kg; Total 10 Doses)
n=14 Participants
14 participants enrolled under Amendment 4 received total of 10 doses of ALTB-168
|
|---|---|---|
|
Flexible Sigmoidoscopy Subscore Changes From Baseline
Flexible Sigmoidoscopy Score at Baseline
|
2.7 score on a scale
Standard Deviation 0.5
|
2.6 score on a scale
Standard Deviation 0.5
|
|
Flexible Sigmoidoscopy Subscore Changes From Baseline
Flexible Sigmoidoscopy Score at week 12 CFB
|
-0.7 score on a scale
Standard Deviation 1.03
|
-0.6 score on a scale
Standard Deviation 1.0
|
|
Flexible Sigmoidoscopy Subscore Changes From Baseline
Flexible Sigmoidoscopy Score at week 26 CFB
|
0 score on a scale
Standard Deviation 0
|
-0.6 score on a scale
Standard Deviation 1.27
|
SECONDARY outcome
Timeframe: at 12- and 26-week after the first treatmentPopulation: Study participants who received at least one dose of ALTB-168. Missing data imputed as non-responders (i.e. Amd 1-3: Week 12 - 3 missing; Week 26 - 8 missing; and Amd 4: Week 12 - 2 missing; Week 26 - 7 missing).
The mucosal healing is defined as an absolute subscore for endoscopy of 0 or 1 The colonic site with maximum inflammation was determined by Mayo endoscopic subscore (MES) defined as follows: normal (0 points); erythema, decreased vascular pattern, mild friability (1 point); absent vascular pattern, friability, erosions (2 points); and spontaneous bleeding or ulceration (3 points). Lower score means disease improvement.
Outcome measures
| Measure |
Pilot Study (Amendment 1~3: 9 mg/kg; Total 8 Doses)
n=9 Participants
10 participants enrolled under protocol Amendments 1-3 received total of 8 doses of ALTB-168
|
Main Study (Amendment 4: 9 mg/kg; Total 10 Doses)
n=14 Participants
14 participants enrolled under Amendment 4 received total of 10 doses of ALTB-168
|
|---|---|---|
|
The Number of Patients With Mucosal Healing
Week 12
|
2 participants
|
4 participants
|
|
The Number of Patients With Mucosal Healing
Week 26
|
0 participants
|
3 participants
|
SECONDARY outcome
Timeframe: at 12- and 26-week after the first treatmentPopulation: Study participants who received at least one dose of ALTB-168
The number of patients with histological activity Geboes Score ≤ 3.1 (worst of both rectum and sigmoid colon). The original Geboes grade system is from Grade 0 to Grade 5. The following are the grades: Grade 0: Architectural changes Grade 1: Chronic inflammatory infiltrate Grade 2A: Eosinophils in lamina propria Grade 2B: Neutrophils in lamina propria Grade 3: Neutrophils in epithelium Grade 4:Crypt destruction Grade 5: Erosions and ulcerations
Outcome measures
| Measure |
Pilot Study (Amendment 1~3: 9 mg/kg; Total 8 Doses)
n=9 Participants
10 participants enrolled under protocol Amendments 1-3 received total of 8 doses of ALTB-168
|
Main Study (Amendment 4: 9 mg/kg; Total 10 Doses)
n=14 Participants
14 participants enrolled under Amendment 4 received total of 10 doses of ALTB-168
|
|---|---|---|
|
Change of Histological Activity Grade From Baseline Using the Geboes System
Week 12
|
0 participants
|
2 participants
|
|
Change of Histological Activity Grade From Baseline Using the Geboes System
Week 26
|
1 participants
|
4 participants
|
SECONDARY outcome
Timeframe: at 12- and 26-week after the first treatmentPopulation: Study participants who received at least one dose of ALTB-168. Missing data imputed as non-responders (i.e. Amd 1-3: Week 12 - 4 missing; Week 26 - 8 missing; and Amd 4: Week 12 - 2 missing; Week 26 - 7 missing).
The histological healing is defined as histological grade = 0
Outcome measures
| Measure |
Pilot Study (Amendment 1~3: 9 mg/kg; Total 8 Doses)
n=9 Participants
10 participants enrolled under protocol Amendments 1-3 received total of 8 doses of ALTB-168
|
Main Study (Amendment 4: 9 mg/kg; Total 10 Doses)
n=14 Participants
14 participants enrolled under Amendment 4 received total of 10 doses of ALTB-168
|
|---|---|---|
|
The Number of Patients With Histological Healing
Week 12
|
0 Participants
|
0 Participants
|
|
The Number of Patients With Histological Healing
Week 26
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: at 12- and 26-week after the first treatmentPopulation: Study participants who received at least one dose of ALTB-168. Missing data imputed as non-responders (i.e. Amd 1-3: Week 12 - 3 missing; Week 26 - 8 missing; and Amd 4: Week 12 - 0 missing; Week 26 - 6 missing).
Number of Participants with a Clinically Significant Difference in the Inflammatory Bowel Disease Questionnaire (IBDQ) Score From Baseline, to Week 12 and Week 26. The IBDQ is a questionnaire used for an assessment of Health Related Quality of Life (HRQoL) in patients with the Inflammatory Bowel Disease (IBD). The IBDQ has a possible score range of 32 (minimum) to 224 (maximum), where a higher score indicates better HRQoL. A difference of 16 points from Baseline Assessment (Baseline Score) to Week 12, and Baseline Assessment (Baseline Score) to Week 26, is considered clinically significant. The outcome measure is assessed by comparing each patient's change in individual IBDQ score from Baseline to Week 12, and from Baseline to Week 26. Patients who achieved the 16 point difference (improvement of the IBDQ score from the baseline indicating the Clinically Significant Difference) are included as responders to the treatment.
Outcome measures
| Measure |
Pilot Study (Amendment 1~3: 9 mg/kg; Total 8 Doses)
n=9 Participants
10 participants enrolled under protocol Amendments 1-3 received total of 8 doses of ALTB-168
|
Main Study (Amendment 4: 9 mg/kg; Total 10 Doses)
n=14 Participants
14 participants enrolled under Amendment 4 received total of 10 doses of ALTB-168
|
|---|---|---|
|
Change of Inflammatory Bowel Disease Questionnaire (IBDQ) Score From Baseline
Week 12
|
2 participants
|
9 participants
|
|
Change of Inflammatory Bowel Disease Questionnaire (IBDQ) Score From Baseline
Week 26
|
1 participants
|
7 participants
|
SECONDARY outcome
Timeframe: at 12- and 26-week after the first treatmentPopulation: Study participants who received at least one dose of ALTB-168. Missing data imputed as non-responders (i.e. Amd 1-3: Week 12 - 3 missing; Week 26 - 8 missing; and Amd 4: Week 12 - 0 missing; Week 26 - 6 missing).
The Inflammatory Bowel Disease Questionnaire (IBDQ) has a possible score range of 32 (minimum) to 224 (maximum), where a higher score indicates better Health Related Quality of Life (HRQoL). A difference of 16 points from Baseline to Week 12 and Baseline to Week 26, is considered clinically significant. The outcome measure will be assessed by comparing each patient's change in individual IBDQ score from Baseline to Week 12, and from Baseline to Week 26, to assess whether a response was seen.
Outcome measures
| Measure |
Pilot Study (Amendment 1~3: 9 mg/kg; Total 8 Doses)
n=9 Participants
10 participants enrolled under protocol Amendments 1-3 received total of 8 doses of ALTB-168
|
Main Study (Amendment 4: 9 mg/kg; Total 10 Doses)
n=14 Participants
14 participants enrolled under Amendment 4 received total of 10 doses of ALTB-168
|
|---|---|---|
|
The Number of Patients With Inflammatory IBDQ Response
Week 12
|
2 participants
|
9 participants
|
|
The Number of Patients With Inflammatory IBDQ Response
Week 26
|
1 participants
|
7 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Am 4, Weeks 4, 9, 12, 16, 20, 26; Am 1-3 weeks 4,8,12,16,20, 26Population: Study participants who received at least one dose of ALTB-168
Change in biomarkers of CRP (C-reactive protein). C-reactive protein (CRP) is a biomarker produced by your liver in response to inflammation. Normal CRP value is below 1 mg/L. 1-3 mg/L is in the "yellow zone", indicating some inflammation \>3 mg/L is in the "red zone", meaning there is significant inflammation
Outcome measures
| Measure |
Pilot Study (Amendment 1~3: 9 mg/kg; Total 8 Doses)
n=9 Participants
10 participants enrolled under protocol Amendments 1-3 received total of 8 doses of ALTB-168
|
Main Study (Amendment 4: 9 mg/kg; Total 10 Doses)
n=14 Participants
14 participants enrolled under Amendment 4 received total of 10 doses of ALTB-168
|
|---|---|---|
|
CRP Changes From Baseline (CFB) (Exploratory)
Week 26
|
NA mg/L
Standard Deviation NA
Only 1 participant
|
-0.42 mg/L
Standard Deviation 4.079
|
|
CRP Changes From Baseline (CFB) (Exploratory)
Baseline
|
4.3 mg/L
Standard Deviation 5.32
|
11.29 mg/L
Standard Deviation 20.555
|
|
CRP Changes From Baseline (CFB) (Exploratory)
Week 4
|
6.5 mg/L
Standard Deviation 17.30
|
-1.93 mg/L
Standard Deviation 14.403
|
|
CRP Changes From Baseline (CFB) (Exploratory)
Am 4 Week 9, Am 1-3 Week 8
|
6.2 mg/L
Standard Deviation 10.65
|
-0.42 mg/L
Standard Deviation 18.821
|
|
CRP Changes From Baseline (CFB) (Exploratory)
Week 12
|
6.0 mg/L
Standard Deviation 8.49
|
0.12 mg/L
Standard Deviation 15.605
|
|
CRP Changes From Baseline (CFB) (Exploratory)
Week 16
|
NA mg/L
Standard Deviation NA
Only 1 participant
|
-0.65 mg/L
Standard Deviation 13.450
|
|
CRP Changes From Baseline (CFB) (Exploratory)
Week 20
|
NA mg/L
Standard Deviation NA
Only 1 participant
|
-2.94 mg/L
Standard Deviation 14.161
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Am 4, Weeks 4, 9, 12, 16, 20, 26; Am 1-3 weeks 4,8,12,16,20, 26Population: Study participants who received at least one dose of ALTB-168
Faecal calprotectin changes from the baseline at Week 4, 9, 12, 16, 20, and 26 were measured. Baseline is defined as the last available assessment prior to the first administration of the study drug. Faecal calprotectin is measured as mcg/g, so the results come back as a numeric value. A level under 50 is considered to be 'normal'. A level between 50 and 100, coupled with digestive symptoms, means IBS is likely. Lower level means improvement.
Outcome measures
| Measure |
Pilot Study (Amendment 1~3: 9 mg/kg; Total 8 Doses)
n=9 Participants
10 participants enrolled under protocol Amendments 1-3 received total of 8 doses of ALTB-168
|
Main Study (Amendment 4: 9 mg/kg; Total 10 Doses)
n=14 Participants
14 participants enrolled under Amendment 4 received total of 10 doses of ALTB-168
|
|---|---|---|
|
Changes in Fecal Calprotectin (CFB) - Exploratory Biomarker
Baseline
|
682.80 mcg/g
Standard Deviation 548.153
|
1283.49 mcg/g
Standard Deviation 758.019
|
|
Changes in Fecal Calprotectin (CFB) - Exploratory Biomarker
Week 4 (CFB)
|
113.89 mcg/g
Standard Deviation 753.179
|
-203.30 mcg/g
Standard Deviation 704.559
|
|
Changes in Fecal Calprotectin (CFB) - Exploratory Biomarker
Week 9 (Am 4, week 8 Am 1-3)
|
223.17 mcg/g
Standard Deviation 605.971
|
-384.47 mcg/g
Standard Deviation 662.420
|
|
Changes in Fecal Calprotectin (CFB) - Exploratory Biomarker
Week 12
|
923.00 mcg/g
Standard Deviation 997.162
|
-584.17 mcg/g
Standard Deviation 847.809
|
|
Changes in Fecal Calprotectin (CFB) - Exploratory Biomarker
Week 16
|
NA mcg/g
Standard Deviation NA
Only 1 participant
|
-155.01 mcg/g
Standard Deviation 1142.984
|
|
Changes in Fecal Calprotectin (CFB) - Exploratory Biomarker
Week 20
|
NA mcg/g
Standard Deviation NA
Only 1 participant
|
-29.46 mcg/g
Standard Deviation 477.150
|
|
Changes in Fecal Calprotectin (CFB) - Exploratory Biomarker
Week 26
|
NA mcg/g
Standard Deviation NA
Only 1 participant
|
-780.30 mcg/g
Standard Deviation 633.292
|
Adverse Events
ALTB-168 9mg/kg (Amendment 1-3)
ALTB-168 9mg/kg (Amendment 4)
Serious adverse events
| Measure |
ALTB-168 9mg/kg (Amendment 1-3)
n=10 participants at risk
Amendments 1-3: A total of 8 doses of ALTB-168 at 9 mg/kg
|
ALTB-168 9mg/kg (Amendment 4)
n=14 participants at risk
Amendment 4: A total of 10 doses of ALTB-168 at 9 mg/kg
|
|---|---|---|
|
Gastrointestinal disorders
Ulcerative Colitis Flare
|
10.0%
1/10 • Number of events 1 • 26 weeks
|
0.00%
0/14 • 26 weeks
|
Other adverse events
| Measure |
ALTB-168 9mg/kg (Amendment 1-3)
n=10 participants at risk
Amendments 1-3: A total of 8 doses of ALTB-168 at 9 mg/kg
|
ALTB-168 9mg/kg (Amendment 4)
n=14 participants at risk
Amendment 4: A total of 10 doses of ALTB-168 at 9 mg/kg
|
|---|---|---|
|
Gastrointestinal disorders
Constipation
|
10.0%
1/10 • Number of events 1 • 26 weeks
|
0.00%
0/14 • 26 weeks
|
|
General disorders
Chills
|
10.0%
1/10 • Number of events 1 • 26 weeks
|
0.00%
0/14 • 26 weeks
|
|
General disorders
Fatigue
|
10.0%
1/10 • Number of events 1 • 26 weeks
|
0.00%
0/14 • 26 weeks
|
|
General disorders
Pyrexia
|
10.0%
1/10 • Number of events 1 • 26 weeks
|
0.00%
0/14 • 26 weeks
|
|
Infections and infestations
Vulvovaginal Candidiasis
|
0.00%
0/10 • 26 weeks
|
7.1%
1/14 • 26 weeks
|
|
Nervous system disorders
Headache
|
50.0%
5/10 • Number of events 5 • 26 weeks
|
35.7%
5/14 • Number of events 5 • 26 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
20.0%
2/10 • Number of events 2 • 26 weeks
|
7.1%
1/14 • Number of events 1 • 26 weeks
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/10 • 26 weeks
|
21.4%
3/14 • Number of events 3 • 26 weeks
|
|
Injury, poisoning and procedural complications
Confusion
|
0.00%
0/10 • 26 weeks
|
14.3%
2/14 • Number of events 2 • 26 weeks
|
|
Investigations
Blood Creatinine Increased
|
0.00%
0/10 • 26 weeks
|
7.1%
1/14 • Number of events 1 • 26 weeks
|
|
Investigations
Fecal Calprotectin Increased
|
0.00%
0/10 • 26 weeks
|
14.3%
2/14 • Number of events 2 • 26 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/10 • 26 weeks
|
7.1%
1/14 • Number of events 1 • 26 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
10.0%
1/10 • Number of events 1 • 26 weeks
|
0.00%
0/14 • 26 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
10.0%
1/10 • Number of events 1 • 26 weeks
|
0.00%
0/14 • 26 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Sinus Congestion
|
10.0%
1/10 • Number of events 1 • 26 weeks
|
0.00%
0/14 • 26 weeks
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/10 • 26 weeks
|
14.3%
2/14 • Number of events 2 • 26 weeks
|
|
Skin and subcutaneous tissue disorders
Rash Pruritic
|
10.0%
1/10 • Number of events 1 • 26 weeks
|
0.00%
0/14 • 26 weeks
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/10 • 26 weeks
|
14.3%
2/14 • Number of events 2 • 26 weeks
|
|
Infections and infestations
Urinary Tract Infection
|
10.0%
1/10 • Number of events 1 • 26 weeks
|
0.00%
0/14 • 26 weeks
|
|
Injury, poisoning and procedural complications
Palate Injury
|
10.0%
1/10 • Number of events 1 • 26 weeks
|
0.00%
0/14 • 26 weeks
|
|
Injury, poisoning and procedural complications
Road Traffic Accident
|
10.0%
1/10 • Number of events 1 • 26 weeks
|
0.00%
0/14 • 26 weeks
|
|
Investigations
Blood Pressure Increased
|
10.0%
1/10 • Number of events 1 • 26 weeks
|
0.00%
0/14 • 26 weeks
|
|
Blood and lymphatic system disorders
Lymphocyte Count Decreased
|
10.0%
1/10 • Number of events 1 • 26 weeks
|
0.00%
0/14 • 26 weeks
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
10.0%
1/10 • Number of events 1 • 26 weeks
|
0.00%
0/14 • 26 weeks
|
|
Musculoskeletal and connective tissue disorders
Groin Pain
|
10.0%
1/10 • Number of events 1 • 26 weeks
|
0.00%
0/14 • 26 weeks
|
|
Blood and lymphatic system disorders
Anemia
|
10.0%
1/10 • Number of events 1 • 26 weeks
|
0.00%
0/14 • 26 weeks
|
|
Ear and labyrinth disorders
Ear Swelling
|
10.0%
1/10 • Number of events 1 • 26 weeks
|
0.00%
0/14 • 26 weeks
|
|
Gastrointestinal disorders
Dyspepsia
|
10.0%
1/10 • Number of events 1 • 26 weeks
|
0.00%
0/14 • 26 weeks
|
|
Gastrointestinal disorders
Oral Pain
|
10.0%
1/10 • Number of events 1 • 26 weeks
|
0.00%
0/14 • 26 weeks
|
|
Gastrointestinal disorders
Tongue Ulceration
|
10.0%
1/10 • Number of events 1 • 26 weeks
|
0.00%
0/14 • 26 weeks
|
|
Infections and infestations
Body Tinea
|
0.00%
0/10 • 26 weeks
|
7.1%
1/14 • Number of events 1 • 26 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place