Trial Outcomes & Findings for Study of NDI-034858 in Participants With Moderate to Severe Plaque Psoriasis (NCT NCT04999839)

Last Updated: 2023-09-28

Results Overview

The PASI quantifies the severity of a participant's psoriasis based on both "lesion severity" and the "percent of body surface area (BSA)" affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin\], and lower limbs \[including buttocks\]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI composite score varies in increments of 0.1 and range from 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. PASI 75 response is a binary measure defined as at least a 75% improvement in PASI score at Week 12, relative to baseline PASI score.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

259 participants

Primary outcome timeframe

Baseline, Week 12

Results posted on

2023-09-28

Participant Flow

This study was conducted at 55 study centers in the United States and Canada from 11 August 2021 to 12 September 2022.

A total of 259 participants received either one of the four doses of NDI-034858 (2 milligrams \[mg\], 5 mg, 15 mg, or 30 mg), or matching placebo.

Participant milestones

Participant milestones
Measure	Placebo Participants received placebo matched to NDI-034858 oral capsules, once daily (QD) for up to 12 weeks.	NDI-034858 2 mg Participants received 2 mg of NDI-034858 oral capsules, QD for up to 12 weeks.	NDI-034858 5 mg Participants received 5 mg of NDI-034858 oral capsules, QD for up to 12 weeks.	NDI-034858 15 mg Participants received 15 mg of NDI-034858 oral capsules, QD for up to 12 weeks.	NDI-034858 30 mg Participants received 30 mg (2\*15 mg) of NDI-034858 oral capsules, QD for up to 12 weeks.
Overall Study STARTED	52	50	52	53	52
Overall Study COMPLETED	43	42	45	46	47
Overall Study NOT COMPLETED	9	8	7	7	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Participants received placebo matched to NDI-034858 oral capsules, once daily (QD) for up to 12 weeks.	NDI-034858 2 mg Participants received 2 mg of NDI-034858 oral capsules, QD for up to 12 weeks.	NDI-034858 5 mg Participants received 5 mg of NDI-034858 oral capsules, QD for up to 12 weeks.	NDI-034858 15 mg Participants received 15 mg of NDI-034858 oral capsules, QD for up to 12 weeks.	NDI-034858 30 mg Participants received 30 mg (2\*15 mg) of NDI-034858 oral capsules, QD for up to 12 weeks.
Overall Study Adverse Event	1	1	1	1	1
Overall Study Lost to Follow-up	2	0	2	4	1
Overall Study Withdrawal by Subject	6	5	3	2	2
Overall Study Lack of Efficacy	0	1	0	0	0
Overall Study Physician Decision	0	0	0	0	1
Overall Study Sponsor request	0	1	0	0	0
Overall Study Other	0	0	1	0	0

Baseline Characteristics

Study of NDI-034858 in Participants With Moderate to Severe Plaque Psoriasis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=52 Participants Participants received placebo matched to NDI-034858 oral capsules, QD for up to 12 weeks.	NDI-034858 2 mg n=50 Participants Participants received 2 mg of NDI-034858 oral capsules, QD for up to 12 weeks.	NDI-034858 5 mg n=52 Participants Participants received 5 mg of NDI-034858 oral capsules, QD for up to 12 weeks.	NDI-034858 15 mg n=53 Participants Participants received 15 mg of NDI-034858 oral capsules, QD for up to 12 weeks.	NDI-034858 30 mg n=52 Participants Participants received 30 mg (2\*15 mg) of NDI-034858 oral capsules, QD for up to 12 weeks.	Total n=259 Participants Total of all reporting groups
Age, Continuous	48.8 years STANDARD_DEVIATION 12.70 • n=5 Participants	45.8 years STANDARD_DEVIATION 14.17 • n=7 Participants	45.1 years STANDARD_DEVIATION 13.60 • n=5 Participants	46.2 years STANDARD_DEVIATION 13.02 • n=4 Participants	48.5 years STANDARD_DEVIATION 11.41 • n=21 Participants	46.9 years STANDARD_DEVIATION 12.99 • n=8 Participants
Sex: Female, Male Female	21 Participants n=5 Participants	12 Participants n=7 Participants	11 Participants n=5 Participants	19 Participants n=4 Participants	19 Participants n=21 Participants	82 Participants n=8 Participants
Sex: Female, Male Male	31 Participants n=5 Participants	38 Participants n=7 Participants	41 Participants n=5 Participants	34 Participants n=4 Participants	33 Participants n=21 Participants	177 Participants n=8 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	26 Participants n=5 Participants	21 Participants n=7 Participants	12 Participants n=5 Participants	19 Participants n=4 Participants	15 Participants n=21 Participants	93 Participants n=8 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	26 Participants n=5 Participants	29 Participants n=7 Participants	40 Participants n=5 Participants	34 Participants n=4 Participants	37 Participants n=21 Participants	166 Participants n=8 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	2 Participants n=21 Participants	5 Participants n=8 Participants
Race (NIH/OMB) Asian	5 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants	2 Participants n=4 Participants	3 Participants n=21 Participants	20 Participants n=8 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=5 Participants	3 Participants n=4 Participants	4 Participants n=21 Participants	17 Participants n=8 Participants
Race (NIH/OMB) White	44 Participants n=5 Participants	43 Participants n=7 Participants	40 Participants n=5 Participants	46 Participants n=4 Participants	42 Participants n=21 Participants	215 Participants n=8 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	2 Participants n=8 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
Psoriasis Area and Severity Index (PASI)	18.27 score on a scale STANDARD_DEVIATION 8.120 • n=5 Participants	18.37 score on a scale STANDARD_DEVIATION 6.752 • n=7 Participants	18.60 score on a scale STANDARD_DEVIATION 6.050 • n=5 Participants	15.52 score on a scale STANDARD_DEVIATION 4.504 • n=4 Participants	17.63 score on a scale STANDARD_DEVIATION 6.220 • n=21 Participants	17.67 score on a scale STANDARD_DEVIATION 6.477 • n=8 Participants
Dermatology Life Quality Index (DLQI)	12.4 score on a scale STANDARD_DEVIATION 7.04 • n=5 Participants	10.3 score on a scale STANDARD_DEVIATION 6.19 • n=7 Participants	12.8 score on a scale STANDARD_DEVIATION 7.45 • n=5 Participants	11.9 score on a scale STANDARD_DEVIATION 7.10 • n=4 Participants	12.5 score on a scale STANDARD_DEVIATION 6.87 • n=21 Participants	12.0 score on a scale STANDARD_DEVIATION 6.95 • n=8 Participants

PRIMARY outcome

Timeframe: Baseline, Week 12

Population: The mITT analysis set included all participants who were randomized and received at least one dose of study treatment.

Outcome measures

Outcome measures
Measure	NDI-034858 5 mg n=52 Participants Participants received 5 mg of NDI-034858 oral capsules, QD for up to 12 weeks.	NDI-034858 15 mg n=53 Participants Participants received 15 mg of NDI-034858 oral capsules, QD for up to 12 weeks.	NDI-034858 30 mg n=52 Participants Participants received 30 mg (2\*15 mg) of NDI-034858 oral capsules, QD for up to 12 weeks.	Placebo n=52 Participants Participants received placebo matched to NDI-034858 oral capsules, QD for up to 12 weeks.	NDI-034858 2 mg n=50 Participants Participants received 2 mg of NDI-034858 oral capsules, QD for up to 12 weeks.
Percentage of Participants Who Achieved at Least 75 Percent (%) Improvement From Baseline in Psoriasis Area and Severity Index (PASI-75) at Week 12	44.2 percentage of participants	67.9 percentage of participants	67.3 percentage of participants	5.8 percentage of participants	18.0 percentage of participants

SECONDARY outcome

Timeframe: At Week 12

Population: The mITT analysis set included all participants who were randomized and received at least one dose of study treatment.

The PGA is a global assessment of the current state of the disease. It is a 5-point morphological assessment of overall disease severity with scores ranging from 0 to 4, where Score 0: Clear (No signs of psoriasis; post-inflammatory hyperpigmentation may be present); Score 1: Almost clear (No thickening; normal to pink coloration; no to minimal focal scaling); Score 2: Mild (Just detectable to mild thickening; pink to light red coloration; predominantly fine scaling); Score 3: Moderate (Clearly distinguishable to moderate thickening; dull to bright red; clearly distinguishable to moderate erythema; moderate scaling); Score 4: Severe (Severe thickening with hard edges; bright to deep dark red coloration; severe/coarse scaling covering almost all or all lesions). The percentage of participants who achieved a PGA score of clear (0) or almost clear (1) at Week 12 were reported.

Outcome measures

Outcome measures
Measure	NDI-034858 5 mg n=52 Participants Participants received 5 mg of NDI-034858 oral capsules, QD for up to 12 weeks.	NDI-034858 15 mg n=53 Participants Participants received 15 mg of NDI-034858 oral capsules, QD for up to 12 weeks.	NDI-034858 30 mg n=52 Participants Participants received 30 mg (2\*15 mg) of NDI-034858 oral capsules, QD for up to 12 weeks.	Placebo n=52 Participants Participants received placebo matched to NDI-034858 oral capsules, QD for up to 12 weeks.	NDI-034858 2 mg n=50 Participants Participants received 2 mg of NDI-034858 oral capsules, QD for up to 12 weeks.
Percentage of Participants Who Achieved Physician's Global Assessment (PGA) Score of Clear (0) or Almost Clear (1) at Week 12	26.9 percentage of participants	49.1 percentage of participants	51.9 percentage of participants	3.8 percentage of participants	10.0 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: The mITT analysis set included all participants who were randomized and received at least one dose of study treatment.

The PASI quantifies the severity of a participant's psoriasis based on both "lesion severity" and the "percent of BSA" affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin\], and lower limbs \[including buttocks\]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI composite score varies in increments of 0.1 and range from 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. PASI 90 response is a binary measure defined as at least a 90% improvement in PASI score at Week 12, relative to baseline PASI score.

Outcome measures

Outcome measures
Measure	NDI-034858 5 mg n=52 Participants Participants received 5 mg of NDI-034858 oral capsules, QD for up to 12 weeks.	NDI-034858 15 mg n=53 Participants Participants received 15 mg of NDI-034858 oral capsules, QD for up to 12 weeks.	NDI-034858 30 mg n=52 Participants Participants received 30 mg (2\*15 mg) of NDI-034858 oral capsules, QD for up to 12 weeks.	Placebo n=52 Participants Participants received placebo matched to NDI-034858 oral capsules, QD for up to 12 weeks.	NDI-034858 2 mg n=50 Participants Participants received 2 mg of NDI-034858 oral capsules, QD for up to 12 weeks.
Percentage of Participants Who Achieved at Least 90% Improvement From Baseline in Psoriasis Area and Severity Index (PASI-90) at Week 12	21.2 percentage of participants	45.3 percentage of participants	46.2 percentage of participants	0 percentage of participants	8.0 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: The mITT analysis set included all participants who were randomized and received at least one dose of study treatment.

The PASI quantifies the severity of a participant's psoriasis based on both "lesion severity" and the "percent of BSA" affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin\], and lower limbs \[including buttocks\]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI composite score varies in increments of 0.1 and range from 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. PASI 100 response is a binary measure defined as at least a 100% improvement in PASI score at Week 12, relative to baseline PASI score.

Outcome measures

Outcome measures
Measure	NDI-034858 5 mg n=52 Participants Participants received 5 mg of NDI-034858 oral capsules, QD for up to 12 weeks.	NDI-034858 15 mg n=53 Participants Participants received 15 mg of NDI-034858 oral capsules, QD for up to 12 weeks.	NDI-034858 30 mg n=52 Participants Participants received 30 mg (2\*15 mg) of NDI-034858 oral capsules, QD for up to 12 weeks.	Placebo n=52 Participants Participants received placebo matched to NDI-034858 oral capsules, QD for up to 12 weeks.	NDI-034858 2 mg n=50 Participants Participants received 2 mg of NDI-034858 oral capsules, QD for up to 12 weeks.
Percentage of Participants Who Achieved at Least 100% Improvement From Baseline in Psoriasis Area and Severity Index (PASI-100) at Week 12	9.6 percentage of participants	15.1 percentage of participants	32.7 percentage of participants	0 percentage of participants	2.0 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: The mITT analysis set included all participants who were randomized and received at least one dose of study treatment. Overall number of participants analyzed signifies participants who were evaluable for this outcome measure.

The DLQI is a simple 10 question validated questionnaire that has been used in more than 40 different skin conditions. The DLQI is the most frequently used quality of life instrument in studies of randomized controlled trials in dermatology. Each question is scored on a four-point Likert scale: very much (3); a lot (2); a little (1); not at all (0). DLQI total score is defined as the sum of the 10 questions, ranging from 0 (not at all) to 30 (very much). Higher scores indicate more impact on quality of life of participants; and lower scores indicate less impact on the quality of life of participants.

Outcome measures

Outcome measures
Measure	NDI-034858 5 mg n=47 Participants Participants received 5 mg of NDI-034858 oral capsules, QD for up to 12 weeks.	NDI-034858 15 mg n=46 Participants Participants received 15 mg of NDI-034858 oral capsules, QD for up to 12 weeks.	NDI-034858 30 mg n=47 Participants Participants received 30 mg (2\*15 mg) of NDI-034858 oral capsules, QD for up to 12 weeks.	Placebo n=47 Participants Participants received placebo matched to NDI-034858 oral capsules, QD for up to 12 weeks.	NDI-034858 2 mg n=43 Participants Participants received 2 mg of NDI-034858 oral capsules, QD for up to 12 weeks.
Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 12	-7.9 score on a scale Standard Error 0.75	-8.5 score on a scale Standard Error 0.74	-8.9 score on a scale Standard Error 0.75	-4.9 score on a scale Standard Error 0.75	-5.3 score on a scale Standard Error 0.78

SECONDARY outcome

Timeframe: From start of study drug administration up to Week 16

Population: The safety analysis set included all participants who received at least one dose of the study product.

An adverse event (AE) means any untoward medical occurrence in a participant administered a pharmaceutical product; the untoward medical occurrence does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product whether or not it is related to the medicinal product. TEAEs were defined as any AEs with onset date on or after the first study treatment dosing. An SAE was any untoward medical occurrence that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital abnormality or birth defect, an important medical event. TEAEs included both serious and non-serious AEs.

Outcome measures

Outcome measures
Measure	NDI-034858 5 mg n=52 Participants Participants received 5 mg of NDI-034858 oral capsules, QD for up to 12 weeks.	NDI-034858 15 mg n=53 Participants Participants received 15 mg of NDI-034858 oral capsules, QD for up to 12 weeks.	NDI-034858 30 mg n=52 Participants Participants received 30 mg (2\*15 mg) of NDI-034858 oral capsules, QD for up to 12 weeks.	Placebo n=52 Participants Participants received placebo matched to NDI-034858 oral capsules, QD for up to 12 weeks.	NDI-034858 2 mg n=50 Participants Participants received 2 mg of NDI-034858 oral capsules, QD for up to 12 weeks.
Number of Participants With Treatment-emergent Adverse Event (TEAEs) and Serious TEAEs Participants with TEAEs	28 Participants	28 Participants	31 Participants	23 Participants	31 Participants
Number of Participants With Treatment-emergent Adverse Event (TEAEs) and Serious TEAEs Participants with Serious TEAEs	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Week 1: Day 1, Pre-dose and 1-hour post-dose; Week 4: Pre-dose, 1-hour and 4 hours post-dose; Week 8: Pre-dose; Week 12: Post-dose

Population: The pharmacokinetic (PK) analysis set included all participants who received at least one dose of NDI-034858 and had evaluable plasma concentration data. One participant had PK data missing at baseline (Week 1, Day 1: pre-dose) in 30 mg arm but contributed to PK analysis at post baseline timepoints. Number analyzed signifies participants who were evaluable for this outcome measure at specified timepoints. Data for this outcome measure was not planned to be collected and analyzed for placebo arm.

The analysis of NDI-034858 levels in plasma was performed using a validated reversed-phase Ultra High-Performance Liquid Chromatography coupled with tandem mass-spectrometry (UHPLC-MS/MS) method. Here, plasma concentrations of NDI-034858 determined at given timepoints were reported.

Outcome measures

Outcome measures
Measure	NDI-034858 5 mg n=53 Participants Participants received 5 mg of NDI-034858 oral capsules, QD for up to 12 weeks.	NDI-034858 15 mg n=52 Participants Participants received 15 mg of NDI-034858 oral capsules, QD for up to 12 weeks.	NDI-034858 30 mg Participants received 30 mg (2\*15 mg) of NDI-034858 oral capsules, QD for up to 12 weeks.	Placebo n=50 Participants Participants received placebo matched to NDI-034858 oral capsules, QD for up to 12 weeks.	NDI-034858 2 mg n=52 Participants Participants received 2 mg of NDI-034858 oral capsules, QD for up to 12 weeks.
Plasma Concentrations of NDI-034858 in Participants Receiving Active Treatment Week 4: Pre-dose	55.87 nanograms per milliliter Geometric Coefficient of Variation 224.4	82.81 nanograms per milliliter Geometric Coefficient of Variation 658.3	—	7.38 nanograms per milliliter Geometric Coefficient of Variation 146.8	16.22 nanograms per milliliter Geometric Coefficient of Variation 246.8
Plasma Concentrations of NDI-034858 in Participants Receiving Active Treatment Week 4: 1 hour Post-dose	64.28 nanograms per milliliter Geometric Coefficient of Variation 227.6	114.95 nanograms per milliliter Geometric Coefficient of Variation 322.8	—	8.45 nanograms per milliliter Geometric Coefficient of Variation 140.7	21.04 nanograms per milliliter Geometric Coefficient of Variation 167.8
Plasma Concentrations of NDI-034858 in Participants Receiving Active Treatment Week 1, Day 1: Pre-dose	0.50 nanograms per milliliter Geometric Coefficient of Variation 0.0	0.50 nanograms per milliliter Geometric Coefficient of Variation 0.0	—	0.50 nanograms per milliliter Geometric Coefficient of Variation 0.0	0.50 nanograms per milliliter Geometric Coefficient of Variation 0.0
Plasma Concentrations of NDI-034858 in Participants Receiving Active Treatment Week 1, Day 1: 1 hour Post-dose	2.04 nanograms per milliliter Geometric Coefficient of Variation 447.7	3.59 nanograms per milliliter Geometric Coefficient of Variation 810.5	—	0.69 nanograms per milliliter Geometric Coefficient of Variation 63.7	1.85 nanograms per milliliter Geometric Coefficient of Variation 247.7
Plasma Concentrations of NDI-034858 in Participants Receiving Active Treatment Week 4: 4 hours Post-dose	115.04 nanograms per milliliter Geometric Coefficient of Variation 191.6	222.25 nanograms per milliliter Geometric Coefficient of Variation 215.8	—	12.39 nanograms per milliliter Geometric Coefficient of Variation 126.0	33.87 nanograms per milliliter Geometric Coefficient of Variation 128.3
Plasma Concentrations of NDI-034858 in Participants Receiving Active Treatment Week 8: Pre-dose	59.94 nanograms per milliliter Geometric Coefficient of Variation 193.0	103.82 nanograms per milliliter Geometric Coefficient of Variation 367.6	—	7.31 nanograms per milliliter Geometric Coefficient of Variation 169.4	11.54 nanograms per milliliter Geometric Coefficient of Variation 239.7
Plasma Concentrations of NDI-034858 in Participants Receiving Active Treatment Week 12: Post-dose	46.92 nanograms per milliliter Geometric Coefficient of Variation 357.1	55.51 nanograms per milliliter Geometric Coefficient of Variation 1473.5	—	4.66 nanograms per milliliter Geometric Coefficient of Variation 182.9	13.06 nanograms per milliliter Geometric Coefficient of Variation 204.6

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

NDI-034858 2 mg

Serious events: 0 serious events

Other events: 16 other events

Deaths: 0 deaths

NDI-034858 5 mg

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

NDI-034858 15 mg

Serious events: 1 serious events

Other events: 16 other events

Deaths: 0 deaths

NDI-034858 30 mg

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo n=52 participants at risk Participants received placebo matched to NDI-034858 oral capsules, QD for up to 12 weeks.	NDI-034858 2 mg n=50 participants at risk Participants received 2 mg of NDI-034858 oral capsules, QD for up to 12 weeks.	NDI-034858 5 mg n=52 participants at risk Participants received 5 mg of NDI-034858 oral capsules, QD for up to 12 weeks.	NDI-034858 15 mg n=53 participants at risk Participants received 15 mg of NDI-034858 oral capsules, QD for up to 12 weeks.	NDI-034858 30 mg n=52 participants at risk Participants received 30 mg (2\*15 mg) of NDI-034858 oral capsules, QD for up to 12 weeks.
Cardiac disorders Pericardial effusion	0.00% 0/52 • From start of study drug administration up to Week 16	0.00% 0/50 • From start of study drug administration up to Week 16	0.00% 0/52 • From start of study drug administration up to Week 16	1.9% 1/53 • From start of study drug administration up to Week 16	0.00% 0/52 • From start of study drug administration up to Week 16
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/52 • From start of study drug administration up to Week 16	0.00% 0/50 • From start of study drug administration up to Week 16	0.00% 0/52 • From start of study drug administration up to Week 16	1.9% 1/53 • From start of study drug administration up to Week 16	0.00% 0/52 • From start of study drug administration up to Week 16

Other adverse events

Other adverse events
Measure	Placebo n=52 participants at risk Participants received placebo matched to NDI-034858 oral capsules, QD for up to 12 weeks.	NDI-034858 2 mg n=50 participants at risk Participants received 2 mg of NDI-034858 oral capsules, QD for up to 12 weeks.	NDI-034858 5 mg n=52 participants at risk Participants received 5 mg of NDI-034858 oral capsules, QD for up to 12 weeks.	NDI-034858 15 mg n=53 participants at risk Participants received 15 mg of NDI-034858 oral capsules, QD for up to 12 weeks.	NDI-034858 30 mg n=52 participants at risk Participants received 30 mg (2\*15 mg) of NDI-034858 oral capsules, QD for up to 12 weeks.
Skin and subcutaneous tissue disorders Acne	0.00% 0/52 • From start of study drug administration up to Week 16	0.00% 0/50 • From start of study drug administration up to Week 16	1.9% 1/52 • From start of study drug administration up to Week 16	5.7% 3/53 • From start of study drug administration up to Week 16	3.8% 2/52 • From start of study drug administration up to Week 16
Investigations Alanine aminotransferase increased	0.00% 0/52 • From start of study drug administration up to Week 16	6.0% 3/50 • From start of study drug administration up to Week 16	0.00% 0/52 • From start of study drug administration up to Week 16	0.00% 0/53 • From start of study drug administration up to Week 16	1.9% 1/52 • From start of study drug administration up to Week 16
Investigations Blood creatine phosphokinase increased	3.8% 2/52 • From start of study drug administration up to Week 16	4.0% 2/50 • From start of study drug administration up to Week 16	3.8% 2/52 • From start of study drug administration up to Week 16	5.7% 3/53 • From start of study drug administration up to Week 16	5.8% 3/52 • From start of study drug administration up to Week 16
Infections and infestations COVID-19	1.9% 1/52 • From start of study drug administration up to Week 16	12.0% 6/50 • From start of study drug administration up to Week 16	7.7% 4/52 • From start of study drug administration up to Week 16	11.3% 6/53 • From start of study drug administration up to Week 16	13.5% 7/52 • From start of study drug administration up to Week 16
Skin and subcutaneous tissue disorders Dermatitis acneiform	0.00% 0/52 • From start of study drug administration up to Week 16	0.00% 0/50 • From start of study drug administration up to Week 16	1.9% 1/52 • From start of study drug administration up to Week 16	1.9% 1/53 • From start of study drug administration up to Week 16	5.8% 3/52 • From start of study drug administration up to Week 16
Gastrointestinal disorders Diarrhoea	1.9% 1/52 • From start of study drug administration up to Week 16	6.0% 3/50 • From start of study drug administration up to Week 16	1.9% 1/52 • From start of study drug administration up to Week 16	1.9% 1/53 • From start of study drug administration up to Week 16	0.00% 0/52 • From start of study drug administration up to Week 16
Investigations Lymphocyte count decreased	0.00% 0/52 • From start of study drug administration up to Week 16	4.0% 2/50 • From start of study drug administration up to Week 16	5.8% 3/52 • From start of study drug administration up to Week 16	3.8% 2/53 • From start of study drug administration up to Week 16	3.8% 2/52 • From start of study drug administration up to Week 16
Blood and lymphatic system disorders Lymphopenia	5.8% 3/52 • From start of study drug administration up to Week 16	0.00% 0/50 • From start of study drug administration up to Week 16	0.00% 0/52 • From start of study drug administration up to Week 16	1.9% 1/53 • From start of study drug administration up to Week 16	0.00% 0/52 • From start of study drug administration up to Week 16
Blood and lymphatic system disorders Neutropenia	5.8% 3/52 • From start of study drug administration up to Week 16	4.0% 2/50 • From start of study drug administration up to Week 16	0.00% 0/52 • From start of study drug administration up to Week 16	0.00% 0/53 • From start of study drug administration up to Week 16	1.9% 1/52 • From start of study drug administration up to Week 16

Additional Information

Study Director

Takeda

Phone: +1-877-825-3327

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee If a multicenter publication is not submitted within twelve (12) months after conclusion, abandonment or termination of the Study at all sites, or after Sponsor confirms there shall be no multicenter Study publication, the Institution and/or such Principal Investigator may publish the results from the Institution site individually.
Publication restrictions are in place

Restriction type: OTHER