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A Study to Evaluate the Efficacy, Safety, and Tolerability of NDI-034858 in Participants With Active Psoriatic Arthritis
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 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 12
Summary
This trial is testing a new medication called NDI-034858 to help people with active Psoriatic Arthritis. The goal is to see if it can reduce joint pain, swelling, and improve skin conditions. Participants will be monitored for several months to assess the medication's effectiveness and safety.
Eligible Conditions
- Psoriatic Arthritis
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 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 12
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~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 12
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Percentage of Participants Who Achieved at Least an American College of Rheumatology 20 (ACR20) Response at Week 12
Secondary study objectives
Change From Baseline in Dactylitis Count (DC) at Week 12
Change From Baseline in Disease Activity Index for Psoriatic Arthritis (DAPSA) at Week 12
Change From Baseline in HAQ-DI Total Score at Week 12
+13 moreSide effects data
From 2023 Phase 2 trial • 305 Patients • NCT0515314811%
Upper respiratory tract infection
8%
Nasopharyngitis
4%
Rash
3%
Headache
3%
Blood creatine phosphokinase increased
1%
Rash papular
1%
Atrial fibrillation
1%
Cellulitis
1%
Respiratory tract infection
1%
Dermatitis allergic
1%
Coronary artery disease
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
NDI-034858 Low Dose
NDI-034858 Medium Dose
NDI-034858 High Dose
Trial Design
4Treatment groups
Experimental Treatment
Placebo Group
Group I: NDI-034858 Medium DoseExperimental Treatment1 Intervention
Participants received NDI-034858 medium dose, capsules, orally, QD for 12 weeks.
Group II: NDI-034858 Low DoseExperimental Treatment1 Intervention
Participants received NDI-034858 low dose, capsules, orally, QD for 12 weeks.
Group III: NDI-034858 High DoseExperimental Treatment1 Intervention
Participants received NDI-034858 high dose, capsules, orally, QD for 12 weeks.
Group IV: PlaceboPlacebo Group1 Intervention
Participants received placebo capsules, orally, QD for 12 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
NDI-034858
2022
Completed Phase 2
~310
Find a Location
Who is running the clinical trial?
TakedaLead Sponsor
1,240 Previous Clinical Trials
4,149,166 Total Patients Enrolled
2 Trials studying Psoriatic Arthritis
1,688 Patients Enrolled for Psoriatic Arthritis
Nimbus Lakshmi, Inc.Industry Sponsor
1 Previous Clinical Trials
259 Total Patients Enrolled
Medical DirectorStudy DirectorTakeda
2,905 Previous Clinical Trials
8,091,158 Total Patients Enrolled
1 Trials studying Psoriatic Arthritis
1,000 Patients Enrolled for Psoriatic Arthritis
Study DirectorStudy DirectorTakeda
1,289 Previous Clinical Trials
502,068 Total Patients Enrolled
2 Trials studying Psoriatic Arthritis
1,688 Patients Enrolled for Psoriatic Arthritis
Esha Gangolli, PhDStudy DirectorNimbus Lakshmi, Inc.
Bhaskar Srivastava, MDStudy DirectorNimbus Lakshmi, Inc.
2 Previous Clinical Trials
365 Total Patients Enrolled