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NDI-034858 for 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 day 1: pre-dose,1 hour post-dose; week 4: pre-dose, 1 hour, and 4 hours post-dose; week 8: pre-dose and anytime at week 12
Awards & highlights

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

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1: pre-dose,1 hour post-dose; week 4: pre-dose, 1 hour, and 4 hours post-dose; week 8: pre-dose and anytime at week 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1: pre-dose,1 hour post-dose; week 4: pre-dose, 1 hour, and 4 hours post-dose; week 8: pre-dose and anytime at week 12 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Proportion of participants achieving at least an American College of Rheumatology (ACR) 20 response
Secondary outcome measures
Change From Baseline in Disease Activity Index for Psoriatic Arthritis (DAPSA)
Change from baseline in Health Activities Questionnaire - Disability Index (HAQ-DI) score
Change from baseline in Leed's Enthesitis Index (LEI)
+12 more

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: NDI-034858 study drug - Dose 3Experimental Treatment1 Intervention
NDI-034858 study drug will be orally administered QD for 12 weeks
Group II: NDI-034858 study drug - Dose 2Experimental Treatment1 Intervention
NDI-034858 study drug will be orally administered QD for 12 weeks
Group III: NDI-034858 study drug - Dose 1Experimental Treatment1 Intervention
NDI-034858 study drug will be orally administered QD for 12 weeks
Group IV: PlaceboPlacebo Group1 Intervention
Placebo will be orally administered QD for 12 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
NDI-034858
2022
Completed Phase 2
~390

Find a Location

Who is running the clinical trial?

TakedaLead Sponsor
1,202 Previous Clinical Trials
4,177,875 Total Patients Enrolled
Nimbus Lakshmi, Inc.Industry Sponsor
1 Previous Clinical Trials
259 Total Patients Enrolled
Study DirectorStudy DirectorTakeda
1,207 Previous Clinical Trials
489,293 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research endeavor include participants aged 65 and older?

"This medical experiment is accepting volunteers aged 18 or older and not exceeding 70 years in age."

Answered by AI

Has NDI-034858 been authorized by the Food and Drug Administration?

"We assess NDI-034858's safety as a 2 on our scale due to the presence of data supporting its precautionary measures, though efficacy has yet to be established."

Answered by AI

What is the estimated enrollment capacity for this clinical research?

"Nimbus Lakshmi, Inc. require 260 eligible participants to conduct the trial from two medical sites: Inland Rheumatology Clinical Trials in Atlanta and Intergral Rheumatology & Immunology Specialist in Salisbury."

Answered by AI

For whom is this research endeavor open to participation?

"This trial is recruiting 260 individuals diagnosed with psoriatic arthritis between the ages 18 and 70. To be eligible, patients must meet a set of criteria including: having PsA that fulfills Classification Criteria for Psoriatic Arthritis; displaying peripheral symptoms at time of screening; suffering from ≥ 3 tender joints and ≥ 3 swollen joints on day 1; exhibiting plaque psoriasis lesions or characteristic nail changes or documented history thereof; actively managing their conditions despite prior attempts to do so using NSAIDs, DMARDs (methotrexate/sulfasalazine), or TNFi agents over an extended period of time - if"

Answered by AI

How many medical facilities are currently administering this clinical trial?

"This trial has 54 distinct sites of operation, such as Inland Rheumatology Clinical Trials in Atlanta, Intergral Rheumatology & Immunology Specialist in Salisbury, and West Tennessee Research Institute in Upland. Additionally, there are other participating locales."

Answered by AI

Are there any slots available for this trial at the moment?

"This medical experiment is recruiting participants, as indicated by the clinicaltrials.gov website. It was initially made known on June 1st 2022 and updated most recently on October 17th 2022."

Answered by AI

Who else is applying?

What state do they live in?
Tennessee
Virginia
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
3+

Why did patients apply to this trial?

I am interested in TYK2 inhibitors for my condition.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
A Study to Evaluate the Efficacy, Safety, and Tolerability of NDI-034858 in Participants With Active Psoriatic Arthritis
2022. "A Study to Evaluate the Efficacy, Safety, and Tolerability of NDI-034858 in Participants With Active Psoriatic Arthritis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05153148.
~119 spots leftby Apr 2025
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