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NDI-034858 study drug for Plaque Psoriasis

Phase 2
Waitlist Available
Research Sponsored by Takeda
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 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
Awards & highlights

Study Summary

This study is evaluating whether a drug called NDI-034858 can help treat psoriasis.

Eligible Conditions
  • Plaque Psoriasis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~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
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of Participants Who Achieved at Least 75 Percent (%) Improvement From Baseline in Psoriasis Area and Severity Index (PASI-75) at Week 12
Secondary outcome measures
Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 12
Number of Participants With Treatment-emergent Adverse Event (TEAEs) and Serious TEAEs
Percentage of Participants Who Achieved Physician's Global Assessment (PGA) Score of Clear (0) or Almost Clear (1) at Week 12
+3 more

Side effects data

From 2022 Phase 2 trial • 259 Patients • NCT04999839
11%
COVID-19
6%
Blood creatine phosphokinase increased
6%
Acne
4%
Lymphocyte count decreased
2%
Dermatitis acneiform
2%
Diarrhoea
2%
Pericardial effusion
2%
Pleural effusion
2%
Lymphopenia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
NDI-034858 15 mg
NDI-034858 2 mg
NDI-034858 5 mg
NDI-034858 30 mg

Trial Design

5Treatment groups
Experimental Treatment
Placebo Group
Group I: NDI-034858 5 mgExperimental Treatment1 Intervention
Participants received 5 mg of NDI-034858 oral capsules, QD for up to 12 weeks.
Group II: NDI-034858 30 mgExperimental Treatment1 Intervention
Participants received 30 mg (2*15 mg) of NDI-034858 oral capsules, QD for up to 12 weeks.
Group III: NDI-034858 2 milligrams (mg)Experimental Treatment1 Intervention
Participants received 2 mg of NDI-034858 oral capsules, QD for up to 12 weeks.
Group IV: NDI-034858 15 mgExperimental Treatment1 Intervention
Participants received 15 mg of NDI-034858 oral capsules, QD for up to 12 weeks.
Group V: PlaceboPlacebo Group1 Intervention
Participants received placebo matched to NDI-034858 oral capsules, once daily (QD) for up to 12 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
NDI-034858 study drug
2021
Completed Phase 2
~260

Find a Location

Who is running the clinical trial?

TakedaLead Sponsor
1,201 Previous Clinical Trials
4,178,024 Total Patients Enrolled
Nimbus Lakshmi, Inc.Industry Sponsor
1 Previous Clinical Trials
387 Total Patients Enrolled
Innovaderm Research Inc.OTHER
48 Previous Clinical Trials
2,957 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Study of NDI-034858 in Participants With Moderate to Severe Plaque Psoriasis
2021. "Study of NDI-034858 in Participants With Moderate to Severe Plaque Psoriasis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04999839.
~71 spots leftby Apr 2025
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