Trial Outcomes & Findings for A Study to Evaluate the Efficacy, Safety, and Tolerability of NDI-034858 in Participants With Active Psoriatic Arthritis (NCT NCT05153148)
NCT ID: NCT05153148
Last Updated: 2024-05-31
Results Overview
ACR20 is composite measure defined as improvement of 20 percent(%) from baseline in both number of tender (68) \& number of swollen (66) joints \& a 20% improvement in at least 3 of following 5 criteria: patient global assessment of psoriatic arthritis (PGA-PsA) \[visual analog scale (VAS) where, 0=very good, no symptoms \& 100=very poor, severe symptoms\], physician global assessment of psoriatic arthritis (PhGA-PsA) \[(VAS) where 0=no disease activity \& 100=maximum disease activity\], patient global assessment of psoriatic arthritis pain (PGAAP) \[(VAS) where 0=no pain \& 100=most severe pain\], disability history questionnaire i.e., Health Assessment Questionnaire-Disability Index \[HAQ-DI\] (20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip \& activities, 0=without difficulty to 3=unable to do) \& acute phase reactant like high sensitivity C-reactive protein \[hsCRP\]). Percentages are rounded off to the nearest decimal.
COMPLETED
PHASE2
305 participants
Week 12
2024-05-31
Participant Flow
Participants took part in the study at 45 investigative sites in the United States (US), Germany, Poland, and the Czech Republic from 6 January 2022 to 2 June 2023.
A total of 305 participants with a diagnosis of psoriatic arthritis were enrolled in a 1:1:1:1 ratio to receive either one of the 3 doses of NDI-034858 or placebo.
Participant milestones
| Measure |
Placebo
Participants received placebo capsules, orally, once daily (QD) for 12 weeks.
|
NDI-034858 Low Dose
Participants received NDI-034858 low dose, capsules, orally, QD for 12 weeks.
|
NDI-034858 Medium Dose
Participants received NDI-034858 medium dose, capsules, orally, QD for 12 weeks.
|
NDI-034858 High Dose
Participants received NDI-034858 high dose, capsules, orally, QD for 12 weeks.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
75
|
76
|
78
|
76
|
|
Overall Study
COMPLETED
|
66
|
66
|
65
|
60
|
|
Overall Study
NOT COMPLETED
|
9
|
10
|
13
|
16
|
Reasons for withdrawal
| Measure |
Placebo
Participants received placebo capsules, orally, once daily (QD) for 12 weeks.
|
NDI-034858 Low Dose
Participants received NDI-034858 low dose, capsules, orally, QD for 12 weeks.
|
NDI-034858 Medium Dose
Participants received NDI-034858 medium dose, capsules, orally, QD for 12 weeks.
|
NDI-034858 High Dose
Participants received NDI-034858 high dose, capsules, orally, QD for 12 weeks.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
3
|
5
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
6
|
8
|
6
|
8
|
|
Overall Study
Coronavirus Disease 2019 (COVID-19)
|
0
|
0
|
1
|
0
|
|
Overall Study
Randomized Without Dosing due to Ineligibility
|
0
|
0
|
0
|
2
|
|
Overall Study
Reason not Specified
|
1
|
1
|
1
|
1
|
Baseline Characteristics
A Study to Evaluate the Efficacy, Safety, and Tolerability of NDI-034858 in Participants With Active Psoriatic Arthritis
Baseline characteristics by cohort
| Measure |
Placebo
n=72 Participants
Participants received placebo capsules, orally, QD for 12 weeks.
|
NDI-034858 Low Dose
n=71 Participants
Participants received NDI-034858 low dose, capsules, orally, QD for 12 weeks.
|
NDI-034858 Medium Dose
n=75 Participants
Participants received NDI-034858 medium dose, capsules, orally, QD for 12 weeks.
|
NDI-034858 High Dose
n=72 Participants
Participants received NDI-034858 high dose, capsules, orally, QD for 12 weeks.
|
Total
n=290 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
49.7 years
STANDARD_DEVIATION 11.83 • n=5 Participants
|
48.3 years
STANDARD_DEVIATION 10.43 • n=7 Participants
|
52.5 years
STANDARD_DEVIATION 12.15 • n=5 Participants
|
49.0 years
STANDARD_DEVIATION 11.51 • n=4 Participants
|
49.9 years
STANDARD_DEVIATION 11.56 • n=21 Participants
|
|
Sex: Female, Male
Female
|
37 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
43 Participants
n=4 Participants
|
166 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
35 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
124 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
70 Participants
n=5 Participants
|
69 Participants
n=7 Participants
|
71 Participants
n=5 Participants
|
70 Participants
n=4 Participants
|
280 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
White
|
69 Participants
n=5 Participants
|
66 Participants
n=7 Participants
|
71 Participants
n=5 Participants
|
69 Participants
n=4 Participants
|
275 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Non-white
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Missing
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Height
|
170.3 centimeters (cm)
STANDARD_DEVIATION 10.65 • n=5 Participants
|
170.1 centimeters (cm)
STANDARD_DEVIATION 8.67 • n=7 Participants
|
169.0 centimeters (cm)
STANDARD_DEVIATION 9.04 • n=5 Participants
|
170.4 centimeters (cm)
STANDARD_DEVIATION 9.06 • n=4 Participants
|
169.9 centimeters (cm)
STANDARD_DEVIATION 9.35 • n=21 Participants
|
|
Weight
|
86.26 kilograms (kg)
STANDARD_DEVIATION 25.307 • n=5 Participants
|
86.97 kilograms (kg)
STANDARD_DEVIATION 26.611 • n=7 Participants
|
85.85 kilograms (kg)
STANDARD_DEVIATION 22.048 • n=5 Participants
|
87.74 kilograms (kg)
STANDARD_DEVIATION 20.152 • n=4 Participants
|
86.69 kilograms (kg)
STANDARD_DEVIATION 23.529 • n=21 Participants
|
|
Body Mass Index (BMI)
|
29.48 kilograms per meter square (kg/m^2)
STANDARD_DEVIATION 6.865 • n=5 Participants
|
29.78 kilograms per meter square (kg/m^2)
STANDARD_DEVIATION 8.153 • n=7 Participants
|
30.04 kilograms per meter square (kg/m^2)
STANDARD_DEVIATION 7.937 • n=5 Participants
|
30.15 kilograms per meter square (kg/m^2)
STANDARD_DEVIATION 6.610 • n=4 Participants
|
29.87 kilograms per meter square (kg/m^2)
STANDARD_DEVIATION 7.390 • n=21 Participants
|
PRIMARY outcome
Timeframe: Week 12Population: Full Analysis Set included all randomized participants who received at least one dose of study drug.
ACR20 is composite measure defined as improvement of 20 percent(%) from baseline in both number of tender (68) \& number of swollen (66) joints \& a 20% improvement in at least 3 of following 5 criteria: patient global assessment of psoriatic arthritis (PGA-PsA) \[visual analog scale (VAS) where, 0=very good, no symptoms \& 100=very poor, severe symptoms\], physician global assessment of psoriatic arthritis (PhGA-PsA) \[(VAS) where 0=no disease activity \& 100=maximum disease activity\], patient global assessment of psoriatic arthritis pain (PGAAP) \[(VAS) where 0=no pain \& 100=most severe pain\], disability history questionnaire i.e., Health Assessment Questionnaire-Disability Index \[HAQ-DI\] (20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip \& activities, 0=without difficulty to 3=unable to do) \& acute phase reactant like high sensitivity C-reactive protein \[hsCRP\]). Percentages are rounded off to the nearest decimal.
Outcome measures
| Measure |
Placebo
n=72 Participants
Participants received placebo capsules, orally, QD for 12 weeks.
|
NDI-034858 Low Dose
n=71 Participants
Participants received NDI-034858 low dose, capsules, orally, QD for 12 weeks.
|
NDI-034858 Medium Dose
n=75 Participants
Participants received NDI-034858 medium dose, capsules, orally, QD for 12 weeks.
|
NDI-034858 High Dose
n=72 Participants
Participants received NDI-034858 high dose, capsules, orally, QD for 12 weeks.
|
|---|---|---|---|---|
|
Percentage of Participants Who Achieved at Least an American College of Rheumatology 20 (ACR20) Response at Week 12
|
29.2 percentage of participants
Interval 18.7 to 39.7
|
35.2 percentage of participants
Interval 24.1 to 46.3
|
53.3 percentage of participants
Interval 42.0 to 64.6
|
54.2 percentage of participants
Interval 42.7 to 65.7
|
SECONDARY outcome
Timeframe: Week 12Population: Full Analysis Set included all randomized participants who received at least one dose of study drug.
The ACR-50 is a composite measure defined as improvement of 50% from baseline in both the number of tender (68) and number of swollen (66) joints, and a 50% improvement in at least three of the following five criteria: PGA-PsA (VAS where, 0 is 'very good, no symptoms' and 100 is 'very poor, severe symptoms'), PhGA-PsA \[(VAS) where 0=no disease activity and 100=maximum disease activity\], PGAAP \[(VAS) where 0=no pain \& 100=most severe pain\], disability history questionnaire (i.e., HAQ-DI) \[20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do\] and an acute phase reactant \[i.e., erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP)\]. Percentages are rounded off to the nearest decimal.
Outcome measures
| Measure |
Placebo
n=72 Participants
Participants received placebo capsules, orally, QD for 12 weeks.
|
NDI-034858 Low Dose
n=71 Participants
Participants received NDI-034858 low dose, capsules, orally, QD for 12 weeks.
|
NDI-034858 Medium Dose
n=75 Participants
Participants received NDI-034858 medium dose, capsules, orally, QD for 12 weeks.
|
NDI-034858 High Dose
n=72 Participants
Participants received NDI-034858 high dose, capsules, orally, QD for 12 weeks.
|
|---|---|---|---|---|
|
Percentage of Participants Who Achieved at Least an ACR-50 Response at Week 12
|
9.7 percentage of participants
Interval 2.9 to 16.6
|
15.5 percentage of participants
Interval 7.1 to 23.9
|
26.7 percentage of participants
Interval 16.7 to 36.7
|
26.4 percentage of participants
Interval 16.2 to 36.6
|
SECONDARY outcome
Timeframe: Week 12Population: Full Analysis Set included all randomized participants who received at least one dose of study drug.
The ACR-70 is a composite measure defined as improvement of 70% from baseline in both the number of tender (68) and number of swollen (66) joints, and a 70% improvement in at least three of the following five criteria: PGA-PsA (VAS where, 0 is 'very good, no symptoms' and 100 is 'very poor, severe symptoms'), PhGA-PsA \[(VAS) where 0=no disease activity and 100=maximum disease activity\], PGAAP \[(VAS) where 0=no pain \& 100=most severe pain\], disability history questionnaire (i.e., HAQ-DI) \[20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do\] and an acute phase reactant (i.e., ESR or CRP). Percentages are rounded off to the nearest decimal.
Outcome measures
| Measure |
Placebo
n=72 Participants
Participants received placebo capsules, orally, QD for 12 weeks.
|
NDI-034858 Low Dose
n=71 Participants
Participants received NDI-034858 low dose, capsules, orally, QD for 12 weeks.
|
NDI-034858 Medium Dose
n=75 Participants
Participants received NDI-034858 medium dose, capsules, orally, QD for 12 weeks.
|
NDI-034858 High Dose
n=72 Participants
Participants received NDI-034858 high dose, capsules, orally, QD for 12 weeks.
|
|---|---|---|---|---|
|
Percentage of Participants Who Achieved at Least an ACR-70 Response at Week 12
|
5.6 percentage of participants
Interval 1.5 to 13.6
|
8.5 percentage of participants
Interval 2.0 to 14.9
|
14.7 percentage of participants
Interval 6.7 to 22.7
|
13.9 percentage of participants
Interval 5.9 to 21.9
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Full Analysis Set included all randomized participants who received at least one dose of study drug. Overall number analyzed is the number of participants with data available for analyses.
The TJC 68 is a total score of points assigned for the presence of tenderness in the 68 joints in the upper body and upper/lower extremity. The response to tenderness for each joint was evaluated using the following scale: 'Present' was assigned a score of 1 whereas, 'Absent', 'Not Done', 'Not Applicable', or joints with missing response were assigned a score of 0. The sum of all tender joints was derived. The overall tender joint count ranged from 0 to 68, with a higher score indicating a greater degree of tenderness. A negative change from baseline indicates improvement.
Outcome measures
| Measure |
Placebo
n=66 Participants
Participants received placebo capsules, orally, QD for 12 weeks.
|
NDI-034858 Low Dose
n=66 Participants
Participants received NDI-034858 low dose, capsules, orally, QD for 12 weeks.
|
NDI-034858 Medium Dose
n=64 Participants
Participants received NDI-034858 medium dose, capsules, orally, QD for 12 weeks.
|
NDI-034858 High Dose
n=63 Participants
Participants received NDI-034858 high dose, capsules, orally, QD for 12 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in Tender Joint Count (TJC) at Week 12
|
-5.9 tender joints
Standard Error 1.12
|
-7.6 tender joints
Standard Error 1.12
|
-8.9 tender joints
Standard Error 1.12
|
-8.3 tender joints
Standard Error 1.15
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Full Analysis Set included all randomized participants who received at least one dose of study drug. Overall number analyzed is the number of participants with data available for analyses.
The SJC 66 (TJC 68 joint assessment minus hip joints, which cannot be assessed for swelling) is a total score of points assigned for presence of swelling in the 66 joints in the upper body and upper/lower extremity. The response to swelling for each joint was evaluated using the following scale: 'Present' was assigned a score of 1 whereas, 'Absent', 'Not Done', 'Not Applicable', or joints with missing response were assigned a score of 0. The sum of all swollen joints was derived. The overall swollen joint count ranged from 0 to 66, with a higher score indicating a greater degree of swelling. A negative change from baseline indicates improvement.
Outcome measures
| Measure |
Placebo
n=66 Participants
Participants received placebo capsules, orally, QD for 12 weeks.
|
NDI-034858 Low Dose
n=66 Participants
Participants received NDI-034858 low dose, capsules, orally, QD for 12 weeks.
|
NDI-034858 Medium Dose
n=64 Participants
Participants received NDI-034858 medium dose, capsules, orally, QD for 12 weeks.
|
NDI-034858 High Dose
n=63 Participants
Participants received NDI-034858 high dose, capsules, orally, QD for 12 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in Swollen Joint Count (SJC) at Week 12
|
-3.9 swollen joints
Standard Error 0.57
|
-4.8 swollen joints
Standard Error 0.58
|
-5.0 swollen joints
Standard Error 0.58
|
-5.0 swollen joints
Standard Error 0.59
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Full Analysis Set included all randomized participants who received at least one dose of study drug. Overall number analyzed is the number of participants with data available for analyses.
Participants assessed their overall disease status based on symptoms of psoriasis and psoriatic arthritis at the time of the visit using the PGA-PsA VAS of 100 millimeters (mm) which ranges from 0 (very good, no symptoms) to 100 (very poor, severe symptoms). A negative change from Baseline indicates improvement in symptoms.
Outcome measures
| Measure |
Placebo
n=64 Participants
Participants received placebo capsules, orally, QD for 12 weeks.
|
NDI-034858 Low Dose
n=65 Participants
Participants received NDI-034858 low dose, capsules, orally, QD for 12 weeks.
|
NDI-034858 Medium Dose
n=63 Participants
Participants received NDI-034858 medium dose, capsules, orally, QD for 12 weeks.
|
NDI-034858 High Dose
n=62 Participants
Participants received NDI-034858 high dose, capsules, orally, QD for 12 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in PGA-PsA at Week 12
|
-11.1 mm
Standard Error 2.85
|
-12.9 mm
Standard Error 2.84
|
-20.2 mm
Standard Error 2.85
|
-19.8 mm
Standard Error 2.92
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Full Analysis Set included all randomized participants who received at least one dose of study drug. Overall number analyzed is the number of participants with data available for analyses.
Participants assessed their overall psoriatic arthritis-related pain at the time of the visit using the PGAAP VAS of 100 mm which ranges from 0 (no pain) to 100 (most severe pain). A negative change from Baseline indicates improvement in pain.
Outcome measures
| Measure |
Placebo
n=64 Participants
Participants received placebo capsules, orally, QD for 12 weeks.
|
NDI-034858 Low Dose
n=65 Participants
Participants received NDI-034858 low dose, capsules, orally, QD for 12 weeks.
|
NDI-034858 Medium Dose
n=63 Participants
Participants received NDI-034858 medium dose, capsules, orally, QD for 12 weeks.
|
NDI-034858 High Dose
n=62 Participants
Participants received NDI-034858 high dose, capsules, orally, QD for 12 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in PGAAP at Week 12
|
-12.1 mm
Standard Error 2.75
|
-13.0 mm
Standard Error 2.74
|
-18.8 mm
Standard Error 2.75
|
-18.4 mm
Standard Error 2.82
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Full Analysis Set included all randomized participants who received at least one dose of study drug. Overall number analyzed is the number of participants with data available for analyses.
The participants' overall disease status was assessed, taking into account signs, symptoms, and function, of all components of joint and skin affected at the time of the visit and this overall status was rated by the investigator using the PhGA-PsA VAS of 100 mm where 0 is 'very good, asymptomatic, and no limitation of normal activities' and 100 is 'very poor, very severe symptoms which are intolerable, and inability to carry out all normal activities'. A negative change from Baseline indicates improvement in symptoms.
Outcome measures
| Measure |
Placebo
n=65 Participants
Participants received placebo capsules, orally, QD for 12 weeks.
|
NDI-034858 Low Dose
n=66 Participants
Participants received NDI-034858 low dose, capsules, orally, QD for 12 weeks.
|
NDI-034858 Medium Dose
n=64 Participants
Participants received NDI-034858 medium dose, capsules, orally, QD for 12 weeks.
|
NDI-034858 High Dose
n=63 Participants
Participants received NDI-034858 high dose, capsules, orally, QD for 12 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in PhGA-PsA at Week 12
|
-20.7 mm
Standard Error 2.66
|
-29.6 mm
Standard Error 2.65
|
-31.3 mm
Standard Error 2.65
|
-31.6 mm
Standard Error 2.73
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Full Analysis Set included all randomized participants who received at least one dose of study drug. Overall number analyzed is the number of participants with data available for analyses.
The HAQ-DI consists of 20 questions referring to eight domains consisting of dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. Each item is scored from 0 (without any difficulty) to 3 (unable to do). The worst score within each domain will be used as the domain score (i.e., if the score for one question is 1 and 2 for the other, then the worst score for the domain is 2). The HAQ-DI total score is calculated by dividing the sum of the domain scores by the number of non-missing domains. The total score indicates the patient's self-assessed level of functional ability and higher scores indicate worse functional ability. The HAQ-DI total score ranges from 0 to 3. A higher score indicates worse function and greater disability. A negative change from Baseline indicates improved function.
Outcome measures
| Measure |
Placebo
n=66 Participants
Participants received placebo capsules, orally, QD for 12 weeks.
|
NDI-034858 Low Dose
n=66 Participants
Participants received NDI-034858 low dose, capsules, orally, QD for 12 weeks.
|
NDI-034858 Medium Dose
n=64 Participants
Participants received NDI-034858 medium dose, capsules, orally, QD for 12 weeks.
|
NDI-034858 High Dose
n=63 Participants
Participants received NDI-034858 high dose, capsules, orally, QD for 12 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in HAQ-DI Total Score at Week 12
|
-0.22 score on a scale
Standard Error 0.053
|
-0.29 score on a scale
Standard Error 0.053
|
-0.32 score on a scale
Standard Error 0.053
|
-0.28 score on a scale
Standard Error 0.055
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Full Analysis Set included all randomized participants who received at least one dose of study drug. Overall number analyzed is the number of participants with dactylitis at Baseline and with available data.
Tender score (0 = no tenderness, 1 = tender, 2 = tender and wince, 3 = tender and withdraw) is collected for Dactylitis Assessments on the Dactylitis Score Sheet that is used for calculation of total score. DC equals the number of tender fingers and toes (tender score \>0). For participants with dactylitis status absent for all the fingers and toes, the DC is set as 0. The total score range of DC is from 0 to 60, higher scores indicate greater presence of dactylitis. A negative change from baseline indicates improvement.
Outcome measures
| Measure |
Placebo
n=14 Participants
Participants received placebo capsules, orally, QD for 12 weeks.
|
NDI-034858 Low Dose
n=14 Participants
Participants received NDI-034858 low dose, capsules, orally, QD for 12 weeks.
|
NDI-034858 Medium Dose
n=12 Participants
Participants received NDI-034858 medium dose, capsules, orally, QD for 12 weeks.
|
NDI-034858 High Dose
n=14 Participants
Participants received NDI-034858 high dose, capsules, orally, QD for 12 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in Dactylitis Count (DC) at Week 12
|
-2.1 dactylitis count
Standard Error 0.39
|
-0.8 dactylitis count
Standard Error 0.41
|
-2.0 dactylitis count
Standard Error 0.47
|
-1.9 dactylitis count
Standard Error 0.41
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Full Analysis Set included all randomized participants who received at least one dose of study drug. Overall number analyzed is the number of participants who had a baseline LEI score of ≥1 and with data available for analyses.
Enthesitis is assessed using LEI. The enthesitis examination by LEI evaluates the presence or absence of pain by applying local pressure on 6 anatomical sites: medial femoral condyle (left and right), lateral epicondyle (left and right), and the achilles tendon insertion (left and right). Enthesitis at each site is scored as 0 (enthesitis absent) and 1 (enthesitis present). LEI is derived as the sum of the enthesitis score over the 6 sites, divided by the number of sites with non-missing score. The total score ranges from 0 to 6, higher scores indicate greater degree of enthesitis. A negative change from baseline indicates improvement.
Outcome measures
| Measure |
Placebo
n=32 Participants
Participants received placebo capsules, orally, QD for 12 weeks.
|
NDI-034858 Low Dose
n=33 Participants
Participants received NDI-034858 low dose, capsules, orally, QD for 12 weeks.
|
NDI-034858 Medium Dose
n=34 Participants
Participants received NDI-034858 medium dose, capsules, orally, QD for 12 weeks.
|
NDI-034858 High Dose
n=31 Participants
Participants received NDI-034858 high dose, capsules, orally, QD for 12 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in Leeds Enthesitis Index (LEI) at Week 12
|
-0.9 score on a scale
Standard Error 0.24
|
-1.4 score on a scale
Standard Error 0.24
|
-1.6 score on a scale
Standard Error 0.24
|
-1.0 score on a scale
Standard Error 0.25
|
SECONDARY outcome
Timeframe: Week 12Population: Full Analysis Set included all randomized participants who received at least one dose of study drug.
MDA is a measure to indicate a state of minimal disease activity, and is a composite score of 7 domains. A participant is considered as having achieved the MDA if the participant fulfills at least 5 of the following 7 criteria: TJC 68 ≤1; SJC 66 ≤1; Psoriasis area and severity index (PASI) score ≤1 \[The total score ranges from 0 (no disease) to 72 (maximal disease)\] or body surface area (BSA) ≤3%; PGAAP ≤15 \[using VAS on a scale of 0 (no pain) to 100 (serious pain)\]; PGA-PsA ≤20 \[using VAS on a scale of 0 (very well) to 100 (very poor)\]; HAQ-DI score ≤0.5; LEI score ≤1. Percentages are rounded off to the nearest decimal.
Outcome measures
| Measure |
Placebo
n=72 Participants
Participants received placebo capsules, orally, QD for 12 weeks.
|
NDI-034858 Low Dose
n=71 Participants
Participants received NDI-034858 low dose, capsules, orally, QD for 12 weeks.
|
NDI-034858 Medium Dose
n=75 Participants
Participants received NDI-034858 medium dose, capsules, orally, QD for 12 weeks.
|
NDI-034858 High Dose
n=72 Participants
Participants received NDI-034858 high dose, capsules, orally, QD for 12 weeks.
|
|---|---|---|---|---|
|
Percentage of Participants With Minimal Disease Activity (MDA) Response at Week 12
|
12.5 percentage of participants
Interval 4.9 to 20.1
|
18.3 percentage of participants
Interval 9.3 to 27.3
|
28.0 percentage of participants
Interval 17.8 to 38.2
|
29.2 percentage of participants
Interval 18.7 to 39.7
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Full Analysis Set included all randomized participants who received at least one dose of study drug. Overall number analyzed is the number of participants with data available for analyses.
The DAPSA score is a composite score and was calculated using: TJC68, SJC66, PGA-PsA, PGAAP, and hsCRP level (milligram per deciliter \[mg/dL\]). DAPSA scores 0-4 = remission, 5-14 = low disease activity, 15-28 = moderate disease activity, and \>28 = high disease activity. The DAPSA score has a lower bound of 0 and has no upper bound. A higher DAPSA score indicated more active disease activity. A negative change from baseline indicates improvement.
Outcome measures
| Measure |
Placebo
n=64 Participants
Participants received placebo capsules, orally, QD for 12 weeks.
|
NDI-034858 Low Dose
n=64 Participants
Participants received NDI-034858 low dose, capsules, orally, QD for 12 weeks.
|
NDI-034858 Medium Dose
n=63 Participants
Participants received NDI-034858 medium dose, capsules, orally, QD for 12 weeks.
|
NDI-034858 High Dose
n=62 Participants
Participants received NDI-034858 high dose, capsules, orally, QD for 12 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in Disease Activity Index for Psoriatic Arthritis (DAPSA) at Week 12
|
-11.56 score on a scale
Standard Error 1.948
|
-15.30 score on a scale
Standard Error 1.946
|
-17.99 score on a scale
Standard Error 1.943
|
-16.79 score on a scale
Standard Error 1.989
|
SECONDARY outcome
Timeframe: Week 12Population: Full Analysis Set included all randomized participants who received at least one dose of study drug. Overall number analyzed is the number of participants with psoriasis covering ≥ 3% of the BSA at Baseline and with available data.
PASI-75 is assessed in participants with psoriasis involvement for ≥ 3% of the BSA at Baseline and assesses the extent of involvement and severity of psoriasis. To calculate the PASI, the body is divided into 4 regions: the head and neck, trunk, upper limbs, and lower limbs. Each of these areas are assessed separately for the percentage of the area involved and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90% to 100% involvement). The PASI produces a numeric score that can range from 0 (no disease) to 72 (maximal disease). For PASI-75, the improvement threshold from baseline in PASI score is 75%. A higher score indicates more severe disease. Percentages are rounded off to the nearest decimal.
Outcome measures
| Measure |
Placebo
n=39 Participants
Participants received placebo capsules, orally, QD for 12 weeks.
|
NDI-034858 Low Dose
n=39 Participants
Participants received NDI-034858 low dose, capsules, orally, QD for 12 weeks.
|
NDI-034858 Medium Dose
n=46 Participants
Participants received NDI-034858 medium dose, capsules, orally, QD for 12 weeks.
|
NDI-034858 High Dose
n=46 Participants
Participants received NDI-034858 high dose, capsules, orally, QD for 12 weeks.
|
|---|---|---|---|---|
|
Percentage of Participants Who Achieved PASI-75 Response at Week 12
|
15.4 percentage of participants
Interval 4.1 to 26.7
|
25.6 percentage of participants
Interval 11.9 to 39.3
|
28.3 percentage of participants
Interval 15.2 to 41.3
|
45.7 percentage of participants
Interval 31.3 to 60.0
|
SECONDARY outcome
Timeframe: Week 12Population: Full Analysis Set included all randomized participants who received at least one dose of study drug. Overall number analyzed is the number of participants with PhGA-PSO ≥2 at Baseline.
PhGA-PsO responder is defined as participants 1) who had PhGA-PsO score of 0 or 1 at any given post-baseline visit; and 2) who had at least 2-point improvement from baseline. The PhGA-PsO is measured using a 0 to 4 scale with a 0 meaning clear or a 4 meaning severe. The proportion of participants achieving PhGA-PsO response at Week 12 was calculated and analyzed for participants with a score of at least 2 at baseline. Percentages are rounded off to the nearest decimal.
Outcome measures
| Measure |
Placebo
n=57 Participants
Participants received placebo capsules, orally, QD for 12 weeks.
|
NDI-034858 Low Dose
n=54 Participants
Participants received NDI-034858 low dose, capsules, orally, QD for 12 weeks.
|
NDI-034858 Medium Dose
n=63 Participants
Participants received NDI-034858 medium dose, capsules, orally, QD for 12 weeks.
|
NDI-034858 High Dose
n=58 Participants
Participants received NDI-034858 high dose, capsules, orally, QD for 12 weeks.
|
|---|---|---|---|---|
|
Percentage of Participants Who Achieved a Physician Global Assessment of Psoriasis (PhGA-PsO) of 0 or 1 and at Least a 2-point Improvement at Week 12
|
15.8 percentage of participants
Interval 6.3 to 25.3
|
20.4 percentage of participants
Interval 9.6 to 31.1
|
20.6 percentage of participants
Interval 10.6 to 30.6
|
32.8 percentage of participants
Interval 20.7 to 44.8
|
SECONDARY outcome
Timeframe: From first dose of study drug up to end of study (up to Week 16)Population: Safety Analysis Set included all randomized participants who received at least one dose of study drug.
Adverse Event(AE)=medical occurrence that does not necessarily have a causal relationship with this drug also including clinically meaningful findings in laboratory safety tests,vital signs,weight,and electrocardiogram(ECG).TEAEs=AEs occurring at time of or post study drug dosing until study end.SAE=any medical occurrence at any dose that resulted in death,was life-threatening,required inpatient hospitalization/prolongation of existing hospitalization,resulted in persistent or significant disability/incapacity,was a congenital abnormality/birth defect,an important medical event.AESIs included Common Terminology Criteria for Adverse Events(CTCAE)Grade≥2 cytopenia,CTCAE Grade≥3 elevation of creatine phosphokinase(CPK)\[clinically significant or not\]defined as CPK\>5xupper limit of normal(ULN),infections,adverse events of abnormal liver function tests,adverse events of renal dysfunction,major adverse cardiovascular events,thromboembolic events,gastrointestinal perforation,and malignancies.
Outcome measures
| Measure |
Placebo
n=72 Participants
Participants received placebo capsules, orally, QD for 12 weeks.
|
NDI-034858 Low Dose
n=71 Participants
Participants received NDI-034858 low dose, capsules, orally, QD for 12 weeks.
|
NDI-034858 Medium Dose
n=75 Participants
Participants received NDI-034858 medium dose, capsules, orally, QD for 12 weeks.
|
NDI-034858 High Dose
n=72 Participants
Participants received NDI-034858 high dose, capsules, orally, QD for 12 weeks.
|
|---|---|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs)
TEAEs
|
39 Participants
|
42 Participants
|
45 Participants
|
56 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs)
SAEs
|
4 Participants
|
4 Participants
|
3 Participants
|
2 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs)
AESIs
|
19 Participants
|
33 Participants
|
22 Participants
|
38 Participants
|
SECONDARY outcome
Timeframe: Pre-dose, 1 hour post-dose on Day 1 and Week 4, 4 hours post-dose at Week 4, Pre-dose at Week 8, and anytime at Week 12Population: Pharmacokinetic (PK) Analysis Set included all participants in the Safety Analysis Set with at least one evaluable post-dose PK assessment. Number analyzed is the number of participants with data available for analysis at the specified time point.
Plasma concentration of NDI-034858 was measured in participants who received low, medium, or high doses of NDI-034858.
Outcome measures
| Measure |
Placebo
n=71 Participants
Participants received placebo capsules, orally, QD for 12 weeks.
|
NDI-034858 Low Dose
n=75 Participants
Participants received NDI-034858 low dose, capsules, orally, QD for 12 weeks.
|
NDI-034858 Medium Dose
n=72 Participants
Participants received NDI-034858 medium dose, capsules, orally, QD for 12 weeks.
|
NDI-034858 High Dose
Participants received NDI-034858 high dose, capsules, orally, QD for 12 weeks.
|
|---|---|---|---|---|
|
Plasma Concentration of NDI-034858
Week 4: Pre-dose
|
25.26 nanograms per milliliter (ng/mL)
Standard Deviation 17.95
|
82.11 nanograms per milliliter (ng/mL)
Standard Deviation 74.46
|
187.5 nanograms per milliliter (ng/mL)
Standard Deviation 140.9
|
—
|
|
Plasma Concentration of NDI-034858
Week 4: 1 Hour
|
33.03 nanograms per milliliter (ng/mL)
Standard Deviation 24.05
|
112.8 nanograms per milliliter (ng/mL)
Standard Deviation 81.19
|
245.3 nanograms per milliliter (ng/mL)
Standard Deviation 184.6
|
—
|
|
Plasma Concentration of NDI-034858
Week 8: Pre-dose
|
26.99 nanograms per milliliter (ng/mL)
Standard Deviation 21.00
|
78.29 nanograms per milliliter (ng/mL)
Standard Deviation 69.37
|
209.4 nanograms per milliliter (ng/mL)
Standard Deviation 182.0
|
—
|
|
Plasma Concentration of NDI-034858
Day 1: Pre-dose
|
0.000 nanograms per milliliter (ng/mL)
Standard Deviation 0.000
|
0.000 nanograms per milliliter (ng/mL)
Standard Deviation 0.000
|
0.000 nanograms per milliliter (ng/mL)
Standard Deviation 0.000
|
—
|
|
Plasma Concentration of NDI-034858
Day 1: 1 Hour
|
5.860 nanograms per milliliter (ng/mL)
Standard Deviation 7.251
|
25.43 nanograms per milliliter (ng/mL)
Standard Deviation 37.21
|
38.32 nanograms per milliliter (ng/mL)
Standard Deviation 59.74
|
—
|
|
Plasma Concentration of NDI-034858
Week 4: 4 Hours
|
46.68 nanograms per milliliter (ng/mL)
Standard Deviation 25.85
|
149.5 nanograms per milliliter (ng/mL)
Standard Deviation 90.56
|
370.1 nanograms per milliliter (ng/mL)
Standard Deviation 178.4
|
—
|
|
Plasma Concentration of NDI-034858
Week 12: Any Time
|
24.85 nanograms per milliliter (ng/mL)
Standard Deviation 20.58
|
66.17 nanograms per milliliter (ng/mL)
Standard Deviation 51.81
|
178.2 nanograms per milliliter (ng/mL)
Standard Deviation 149.5
|
—
|
Adverse Events
Placebo
NDI-034858 Low Dose
NDI-034858 Medium Dose
NDI-034858 High Dose
Serious adverse events
| Measure |
Placebo
n=72 participants at risk
Participants received placebo capsules, orally, QD for 12 weeks.
|
NDI-034858 Low Dose
n=71 participants at risk
Participants received NDI-034858 low dose, capsules, orally, QD for 12 weeks.
|
NDI-034858 Medium Dose
n=75 participants at risk
Participants received NDI-034858 medium dose, capsules, orally, QD for 12 weeks.
|
NDI-034858 High Dose
n=72 participants at risk
Participants received NDI-034858 high dose, capsules, orally, QD for 12 weeks.
|
|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
1.4%
1/72 • From first dose of study drug up to end of study (up to Week 16)
All-cause Mortality: all enrolled participants. SAEs and Other AEs: Safety Analysis Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/71 • From first dose of study drug up to end of study (up to Week 16)
All-cause Mortality: all enrolled participants. SAEs and Other AEs: Safety Analysis Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/75 • From first dose of study drug up to end of study (up to Week 16)
All-cause Mortality: all enrolled participants. SAEs and Other AEs: Safety Analysis Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/72 • From first dose of study drug up to end of study (up to Week 16)
All-cause Mortality: all enrolled participants. SAEs and Other AEs: Safety Analysis Set included all randomized participants who received at least one dose of study drug.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/72 • From first dose of study drug up to end of study (up to Week 16)
All-cause Mortality: all enrolled participants. SAEs and Other AEs: Safety Analysis Set included all randomized participants who received at least one dose of study drug.
|
1.4%
1/71 • From first dose of study drug up to end of study (up to Week 16)
All-cause Mortality: all enrolled participants. SAEs and Other AEs: Safety Analysis Set included all randomized participants who received at least one dose of study drug.
|
1.3%
1/75 • From first dose of study drug up to end of study (up to Week 16)
All-cause Mortality: all enrolled participants. SAEs and Other AEs: Safety Analysis Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/72 • From first dose of study drug up to end of study (up to Week 16)
All-cause Mortality: all enrolled participants. SAEs and Other AEs: Safety Analysis Set included all randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Bell's palsy
|
0.00%
0/72 • From first dose of study drug up to end of study (up to Week 16)
All-cause Mortality: all enrolled participants. SAEs and Other AEs: Safety Analysis Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/71 • From first dose of study drug up to end of study (up to Week 16)
All-cause Mortality: all enrolled participants. SAEs and Other AEs: Safety Analysis Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/75 • From first dose of study drug up to end of study (up to Week 16)
All-cause Mortality: all enrolled participants. SAEs and Other AEs: Safety Analysis Set included all randomized participants who received at least one dose of study drug.
|
1.4%
1/72 • From first dose of study drug up to end of study (up to Week 16)
All-cause Mortality: all enrolled participants. SAEs and Other AEs: Safety Analysis Set included all randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/72 • From first dose of study drug up to end of study (up to Week 16)
All-cause Mortality: all enrolled participants. SAEs and Other AEs: Safety Analysis Set included all randomized participants who received at least one dose of study drug.
|
1.4%
1/71 • From first dose of study drug up to end of study (up to Week 16)
All-cause Mortality: all enrolled participants. SAEs and Other AEs: Safety Analysis Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/75 • From first dose of study drug up to end of study (up to Week 16)
All-cause Mortality: all enrolled participants. SAEs and Other AEs: Safety Analysis Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/72 • From first dose of study drug up to end of study (up to Week 16)
All-cause Mortality: all enrolled participants. SAEs and Other AEs: Safety Analysis Set included all randomized participants who received at least one dose of study drug.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/72 • From first dose of study drug up to end of study (up to Week 16)
All-cause Mortality: all enrolled participants. SAEs and Other AEs: Safety Analysis Set included all randomized participants who received at least one dose of study drug.
|
1.4%
1/71 • From first dose of study drug up to end of study (up to Week 16)
All-cause Mortality: all enrolled participants. SAEs and Other AEs: Safety Analysis Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/75 • From first dose of study drug up to end of study (up to Week 16)
All-cause Mortality: all enrolled participants. SAEs and Other AEs: Safety Analysis Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/72 • From first dose of study drug up to end of study (up to Week 16)
All-cause Mortality: all enrolled participants. SAEs and Other AEs: Safety Analysis Set included all randomized participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Erythema nodosum
|
0.00%
0/72 • From first dose of study drug up to end of study (up to Week 16)
All-cause Mortality: all enrolled participants. SAEs and Other AEs: Safety Analysis Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/71 • From first dose of study drug up to end of study (up to Week 16)
All-cause Mortality: all enrolled participants. SAEs and Other AEs: Safety Analysis Set included all randomized participants who received at least one dose of study drug.
|
1.3%
1/75 • From first dose of study drug up to end of study (up to Week 16)
All-cause Mortality: all enrolled participants. SAEs and Other AEs: Safety Analysis Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/72 • From first dose of study drug up to end of study (up to Week 16)
All-cause Mortality: all enrolled participants. SAEs and Other AEs: Safety Analysis Set included all randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Gastrointestinal inflammation
|
0.00%
0/72 • From first dose of study drug up to end of study (up to Week 16)
All-cause Mortality: all enrolled participants. SAEs and Other AEs: Safety Analysis Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/71 • From first dose of study drug up to end of study (up to Week 16)
All-cause Mortality: all enrolled participants. SAEs and Other AEs: Safety Analysis Set included all randomized participants who received at least one dose of study drug.
|
1.3%
1/75 • From first dose of study drug up to end of study (up to Week 16)
All-cause Mortality: all enrolled participants. SAEs and Other AEs: Safety Analysis Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/72 • From first dose of study drug up to end of study (up to Week 16)
All-cause Mortality: all enrolled participants. SAEs and Other AEs: Safety Analysis Set included all randomized participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal adenocarcinoma
|
1.4%
1/72 • From first dose of study drug up to end of study (up to Week 16)
All-cause Mortality: all enrolled participants. SAEs and Other AEs: Safety Analysis Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/71 • From first dose of study drug up to end of study (up to Week 16)
All-cause Mortality: all enrolled participants. SAEs and Other AEs: Safety Analysis Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/75 • From first dose of study drug up to end of study (up to Week 16)
All-cause Mortality: all enrolled participants. SAEs and Other AEs: Safety Analysis Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/72 • From first dose of study drug up to end of study (up to Week 16)
All-cause Mortality: all enrolled participants. SAEs and Other AEs: Safety Analysis Set included all randomized participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
1.4%
1/72 • From first dose of study drug up to end of study (up to Week 16)
All-cause Mortality: all enrolled participants. SAEs and Other AEs: Safety Analysis Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/71 • From first dose of study drug up to end of study (up to Week 16)
All-cause Mortality: all enrolled participants. SAEs and Other AEs: Safety Analysis Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/75 • From first dose of study drug up to end of study (up to Week 16)
All-cause Mortality: all enrolled participants. SAEs and Other AEs: Safety Analysis Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/72 • From first dose of study drug up to end of study (up to Week 16)
All-cause Mortality: all enrolled participants. SAEs and Other AEs: Safety Analysis Set included all randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/72 • From first dose of study drug up to end of study (up to Week 16)
All-cause Mortality: all enrolled participants. SAEs and Other AEs: Safety Analysis Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/71 • From first dose of study drug up to end of study (up to Week 16)
All-cause Mortality: all enrolled participants. SAEs and Other AEs: Safety Analysis Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/75 • From first dose of study drug up to end of study (up to Week 16)
All-cause Mortality: all enrolled participants. SAEs and Other AEs: Safety Analysis Set included all randomized participants who received at least one dose of study drug.
|
1.4%
1/72 • From first dose of study drug up to end of study (up to Week 16)
All-cause Mortality: all enrolled participants. SAEs and Other AEs: Safety Analysis Set included all randomized participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Psoriatic arthropathy
|
1.4%
1/72 • From first dose of study drug up to end of study (up to Week 16)
All-cause Mortality: all enrolled participants. SAEs and Other AEs: Safety Analysis Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/71 • From first dose of study drug up to end of study (up to Week 16)
All-cause Mortality: all enrolled participants. SAEs and Other AEs: Safety Analysis Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/75 • From first dose of study drug up to end of study (up to Week 16)
All-cause Mortality: all enrolled participants. SAEs and Other AEs: Safety Analysis Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/72 • From first dose of study drug up to end of study (up to Week 16)
All-cause Mortality: all enrolled participants. SAEs and Other AEs: Safety Analysis Set included all randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/72 • From first dose of study drug up to end of study (up to Week 16)
All-cause Mortality: all enrolled participants. SAEs and Other AEs: Safety Analysis Set included all randomized participants who received at least one dose of study drug.
|
1.4%
1/71 • From first dose of study drug up to end of study (up to Week 16)
All-cause Mortality: all enrolled participants. SAEs and Other AEs: Safety Analysis Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/75 • From first dose of study drug up to end of study (up to Week 16)
All-cause Mortality: all enrolled participants. SAEs and Other AEs: Safety Analysis Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/72 • From first dose of study drug up to end of study (up to Week 16)
All-cause Mortality: all enrolled participants. SAEs and Other AEs: Safety Analysis Set included all randomized participants who received at least one dose of study drug.
|
Other adverse events
| Measure |
Placebo
n=72 participants at risk
Participants received placebo capsules, orally, QD for 12 weeks.
|
NDI-034858 Low Dose
n=71 participants at risk
Participants received NDI-034858 low dose, capsules, orally, QD for 12 weeks.
|
NDI-034858 Medium Dose
n=75 participants at risk
Participants received NDI-034858 medium dose, capsules, orally, QD for 12 weeks.
|
NDI-034858 High Dose
n=72 participants at risk
Participants received NDI-034858 high dose, capsules, orally, QD for 12 weeks.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Aphthous ulcer
|
0.00%
0/72 • From first dose of study drug up to end of study (up to Week 16)
All-cause Mortality: all enrolled participants. SAEs and Other AEs: Safety Analysis Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/71 • From first dose of study drug up to end of study (up to Week 16)
All-cause Mortality: all enrolled participants. SAEs and Other AEs: Safety Analysis Set included all randomized participants who received at least one dose of study drug.
|
1.3%
1/75 • From first dose of study drug up to end of study (up to Week 16)
All-cause Mortality: all enrolled participants. SAEs and Other AEs: Safety Analysis Set included all randomized participants who received at least one dose of study drug.
|
8.3%
6/72 • From first dose of study drug up to end of study (up to Week 16)
All-cause Mortality: all enrolled participants. SAEs and Other AEs: Safety Analysis Set included all randomized participants who received at least one dose of study drug.
|
|
Investigations
Blood creatine phosphokinase increased
|
4.2%
3/72 • From first dose of study drug up to end of study (up to Week 16)
All-cause Mortality: all enrolled participants. SAEs and Other AEs: Safety Analysis Set included all randomized participants who received at least one dose of study drug.
|
2.8%
2/71 • From first dose of study drug up to end of study (up to Week 16)
All-cause Mortality: all enrolled participants. SAEs and Other AEs: Safety Analysis Set included all randomized participants who received at least one dose of study drug.
|
5.3%
4/75 • From first dose of study drug up to end of study (up to Week 16)
All-cause Mortality: all enrolled participants. SAEs and Other AEs: Safety Analysis Set included all randomized participants who received at least one dose of study drug.
|
1.4%
1/72 • From first dose of study drug up to end of study (up to Week 16)
All-cause Mortality: all enrolled participants. SAEs and Other AEs: Safety Analysis Set included all randomized participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.00%
0/72 • From first dose of study drug up to end of study (up to Week 16)
All-cause Mortality: all enrolled participants. SAEs and Other AEs: Safety Analysis Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/71 • From first dose of study drug up to end of study (up to Week 16)
All-cause Mortality: all enrolled participants. SAEs and Other AEs: Safety Analysis Set included all randomized participants who received at least one dose of study drug.
|
2.7%
2/75 • From first dose of study drug up to end of study (up to Week 16)
All-cause Mortality: all enrolled participants. SAEs and Other AEs: Safety Analysis Set included all randomized participants who received at least one dose of study drug.
|
8.3%
6/72 • From first dose of study drug up to end of study (up to Week 16)
All-cause Mortality: all enrolled participants. SAEs and Other AEs: Safety Analysis Set included all randomized participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/72 • From first dose of study drug up to end of study (up to Week 16)
All-cause Mortality: all enrolled participants. SAEs and Other AEs: Safety Analysis Set included all randomized participants who received at least one dose of study drug.
|
1.4%
1/71 • From first dose of study drug up to end of study (up to Week 16)
All-cause Mortality: all enrolled participants. SAEs and Other AEs: Safety Analysis Set included all randomized participants who received at least one dose of study drug.
|
1.3%
1/75 • From first dose of study drug up to end of study (up to Week 16)
All-cause Mortality: all enrolled participants. SAEs and Other AEs: Safety Analysis Set included all randomized participants who received at least one dose of study drug.
|
5.6%
4/72 • From first dose of study drug up to end of study (up to Week 16)
All-cause Mortality: all enrolled participants. SAEs and Other AEs: Safety Analysis Set included all randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Headache
|
4.2%
3/72 • From first dose of study drug up to end of study (up to Week 16)
All-cause Mortality: all enrolled participants. SAEs and Other AEs: Safety Analysis Set included all randomized participants who received at least one dose of study drug.
|
2.8%
2/71 • From first dose of study drug up to end of study (up to Week 16)
All-cause Mortality: all enrolled participants. SAEs and Other AEs: Safety Analysis Set included all randomized participants who received at least one dose of study drug.
|
8.0%
6/75 • From first dose of study drug up to end of study (up to Week 16)
All-cause Mortality: all enrolled participants. SAEs and Other AEs: Safety Analysis Set included all randomized participants who received at least one dose of study drug.
|
5.6%
4/72 • From first dose of study drug up to end of study (up to Week 16)
All-cause Mortality: all enrolled participants. SAEs and Other AEs: Safety Analysis Set included all randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Nasopharyngitis
|
4.2%
3/72 • From first dose of study drug up to end of study (up to Week 16)
All-cause Mortality: all enrolled participants. SAEs and Other AEs: Safety Analysis Set included all randomized participants who received at least one dose of study drug.
|
8.5%
6/71 • From first dose of study drug up to end of study (up to Week 16)
All-cause Mortality: all enrolled participants. SAEs and Other AEs: Safety Analysis Set included all randomized participants who received at least one dose of study drug.
|
9.3%
7/75 • From first dose of study drug up to end of study (up to Week 16)
All-cause Mortality: all enrolled participants. SAEs and Other AEs: Safety Analysis Set included all randomized participants who received at least one dose of study drug.
|
9.7%
7/72 • From first dose of study drug up to end of study (up to Week 16)
All-cause Mortality: all enrolled participants. SAEs and Other AEs: Safety Analysis Set included all randomized participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Psoriatic arthropathy
|
5.6%
4/72 • From first dose of study drug up to end of study (up to Week 16)
All-cause Mortality: all enrolled participants. SAEs and Other AEs: Safety Analysis Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/71 • From first dose of study drug up to end of study (up to Week 16)
All-cause Mortality: all enrolled participants. SAEs and Other AEs: Safety Analysis Set included all randomized participants who received at least one dose of study drug.
|
2.7%
2/75 • From first dose of study drug up to end of study (up to Week 16)
All-cause Mortality: all enrolled participants. SAEs and Other AEs: Safety Analysis Set included all randomized participants who received at least one dose of study drug.
|
1.4%
1/72 • From first dose of study drug up to end of study (up to Week 16)
All-cause Mortality: all enrolled participants. SAEs and Other AEs: Safety Analysis Set included all randomized participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/72 • From first dose of study drug up to end of study (up to Week 16)
All-cause Mortality: all enrolled participants. SAEs and Other AEs: Safety Analysis Set included all randomized participants who received at least one dose of study drug.
|
4.2%
3/71 • From first dose of study drug up to end of study (up to Week 16)
All-cause Mortality: all enrolled participants. SAEs and Other AEs: Safety Analysis Set included all randomized participants who received at least one dose of study drug.
|
8.0%
6/75 • From first dose of study drug up to end of study (up to Week 16)
All-cause Mortality: all enrolled participants. SAEs and Other AEs: Safety Analysis Set included all randomized participants who received at least one dose of study drug.
|
5.6%
4/72 • From first dose of study drug up to end of study (up to Week 16)
All-cause Mortality: all enrolled participants. SAEs and Other AEs: Safety Analysis Set included all randomized participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/72 • From first dose of study drug up to end of study (up to Week 16)
All-cause Mortality: all enrolled participants. SAEs and Other AEs: Safety Analysis Set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/71 • From first dose of study drug up to end of study (up to Week 16)
All-cause Mortality: all enrolled participants. SAEs and Other AEs: Safety Analysis Set included all randomized participants who received at least one dose of study drug.
|
2.7%
2/75 • From first dose of study drug up to end of study (up to Week 16)
All-cause Mortality: all enrolled participants. SAEs and Other AEs: Safety Analysis Set included all randomized participants who received at least one dose of study drug.
|
5.6%
4/72 • From first dose of study drug up to end of study (up to Week 16)
All-cause Mortality: all enrolled participants. SAEs and Other AEs: Safety Analysis Set included all randomized participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/72 • From first dose of study drug up to end of study (up to Week 16)
All-cause Mortality: all enrolled participants. SAEs and Other AEs: Safety Analysis Set included all randomized participants who received at least one dose of study drug.
|
1.4%
1/71 • From first dose of study drug up to end of study (up to Week 16)
All-cause Mortality: all enrolled participants. SAEs and Other AEs: Safety Analysis Set included all randomized participants who received at least one dose of study drug.
|
4.0%
3/75 • From first dose of study drug up to end of study (up to Week 16)
All-cause Mortality: all enrolled participants. SAEs and Other AEs: Safety Analysis Set included all randomized participants who received at least one dose of study drug.
|
5.6%
4/72 • From first dose of study drug up to end of study (up to Week 16)
All-cause Mortality: all enrolled participants. SAEs and Other AEs: Safety Analysis Set included all randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
2.8%
2/72 • From first dose of study drug up to end of study (up to Week 16)
All-cause Mortality: all enrolled participants. SAEs and Other AEs: Safety Analysis Set included all randomized participants who received at least one dose of study drug.
|
11.3%
8/71 • From first dose of study drug up to end of study (up to Week 16)
All-cause Mortality: all enrolled participants. SAEs and Other AEs: Safety Analysis Set included all randomized participants who received at least one dose of study drug.
|
4.0%
3/75 • From first dose of study drug up to end of study (up to Week 16)
All-cause Mortality: all enrolled participants. SAEs and Other AEs: Safety Analysis Set included all randomized participants who received at least one dose of study drug.
|
9.7%
7/72 • From first dose of study drug up to end of study (up to Week 16)
All-cause Mortality: all enrolled participants. SAEs and Other AEs: Safety Analysis Set included all randomized participants who received at least one dose of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
- Publication restrictions are in place
Restriction type: OTHER