NDI-034858 for Psoriatic Arthritis

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Psoriatic Arthritis+2 More
NDI-034858 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will test a new drug, NDI-034858, for treating psoriatic arthritis. The goal is to see if it is effective, safe, and well tolerated.

Eligible Conditions
  • Psoriatic Arthritis

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Psoriatic Arthritis

Study Objectives

1 Primary · 12 Secondary · Reporting Duration: Day 1 to Week 16

Week 16
Change from baseline in Disease Activity Score 28 with CRP(DAS28-CRP)
Change from baseline in Health Activities Questionnaire - Disability Index (HAQ-DI) score
Change from baseline in Leed's Enthesitis Index (LEI)
Change from baseline in Patient Global Assessment of Psoriatic Arthritis
Change from baseline in Patient Global Assessment of Psoriatic Arthritis pain
Change from baseline in Physician Global Assessment of Psoriasis
Change from baseline in Physician Global Assessment of Psoriatic Arthritis
Change from baseline in dactylitis count
Incidence of AEs and TAEs
Proportion of subjects achieving at least an ACR-50 or ACR-70 response
Proportion of subjects achieving at least an American College of Rheumatology (ACR) 20 response
Week 12
Change from baseline in swollen joint count (SJC)
Change from baseline in tender joint count (TJC)

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Other trials for Psoriatic Arthritis

Trial Design

4 Treatment Groups

NDI-034858 study drug - Dose 1
1 of 4
NDI-034858 study drug - Dose 3
1 of 4
NDI-034858 study drug - Dose 2
1 of 4
Placebo
1 of 4
Experimental Treatment
Non-Treatment Group

260 Total Participants · 4 Treatment Groups

Primary Treatment: NDI-034858 · Has Placebo Group · Phase 2

NDI-034858 study drug - Dose 1
Drug
Experimental Group · 1 Intervention: NDI-034858 · Intervention Types: Drug
NDI-034858 study drug - Dose 3
Drug
Experimental Group · 1 Intervention: NDI-034858 · Intervention Types: Drug
NDI-034858 study drug - Dose 2
Drug
Experimental Group · 1 Intervention: NDI-034858 · Intervention Types: Drug
Placebo
Other
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Other

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: day 1 to week 16

Who is running the clinical trial?

Nimbus Lakshmi, Inc.Lead Sponsor
1 Previous Clinical Trials
260 Total Patients Enrolled
Bhaskar Srivastava, MDStudy DirectorNimbus Lakshmi, Inc.
1 Previous Clinical Trials
260 Total Patients Enrolled
Esha Gangolli, PhDStudy DirectorNimbus Lakshmi, Inc.

Eligibility Criteria

Age 18+ · All Participants · 7 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have PsA symptoms for ≥ 6 months prior to the screening visit.
You have 3 or more tender joints and 3 or more swollen joints at screening and Day 1 visits.
Subjects with active PsA who have previously received standard doses of NSAIDs or DMARDs or TNFi agents are eligible.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 10th, 2021

Last Reviewed: October 21st, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

Who else is applying?

What state do they live in?
Tennessee100.0%
How old are they?
18 - 65100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%