A Study to Evaluate the Efficacy, Safety, and Tolerability of NDI-034858 in Participants With Active Psoriatic Arthritis

NCT05153148 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: 4858-2022021-005888-52
• Study Type: interventional
• Target: 305
• Locations: 4 countries
• Sites: 56

Brief Summary

This study is designed to evaluate the efficacy, safety, and tolerability of NDI-034858 in participants with active Psoriatic Arthritis (PsA).

Conditions

Psoriatic Arthritis

Keywords

Placebo-Controlled; Double-blind; Multiple-dose study

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Who Achieved at Least an American College of Rheumatology 20 (ACR20) Response at Week 12

  ACR20 is composite measure defined as improvement of 20 percent(%) from baseline in both number of tender (68) \& number of swollen (66) joints \& a 20% improvement in at least 3 of following 5 criteria: patient global assessment of psoriatic arthritis (PGA-PsA) \[visual analog scale (VAS) where, 0=very good, no symptoms \& 100=very poor, severe symptoms\], physician global assessment of psoriatic arthritis (PhGA-PsA) \[(VAS) where 0=no disease activity \& 100=maximum disease activity\], patient global assessment of psoriatic arthritis pain (PGAAP) \[(VAS) where 0=no pain \& 100=most severe pain\], disability history questionnaire i.e., Health Assessment Questionnaire-Disability Index \[HAQ-DI\] (20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip \& activities, 0=without difficulty to 3=unable to do) \& acute phase reactant like high sensitivity C-reactive protein \[hsCRP\]). Percentages are rounded off to the nearest decimal.

  Week 12

Secondary Outcomes (16)

• Percentage of Participants Who Achieved at Least an ACR-50 Response at Week 12

  Week 12

• Percentage of Participants Who Achieved at Least an ACR-70 Response at Week 12

  Week 12

• Change From Baseline in Tender Joint Count (TJC) at Week 12

  Baseline, Week 12

• Change From Baseline in Swollen Joint Count (SJC) at Week 12

  Baseline, Week 12

• Change From Baseline in PGA-PsA at Week 12

  Baseline, Week 12

Study Arms (4)

Placebo

PLACEBO COMPARATOR

Participants received placebo capsules, orally, QD for 12 weeks.

Other: Placebo

NDI-034858 Low Dose

EXPERIMENTAL

Participants received NDI-034858 low dose, capsules, orally, QD for 12 weeks.

Drug: NDI-034858

NDI-034858 Medium Dose

EXPERIMENTAL

Participants received NDI-034858 medium dose, capsules, orally, QD for 12 weeks.

Drug: NDI-034858

NDI-034858 High Dose

EXPERIMENTAL

Participants received NDI-034858 high dose, capsules, orally, QD for 12 weeks.

Drug: NDI-034858

Interventions

NDI-034858 DRUG

NDI-034858 oral capsule

Also known as: TAK-279

NDI-034858 High Dose; NDI-034858 Low Dose; NDI-034858 Medium Dose

Placebo OTHER

NDI-034858-matching oral placebo capsule

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant has PsA on the basis of the Classification Criteria for Psoriatic Arthritis with peripheral symptoms at the screening visit.
• Participant has a history of PsA symptoms for ≥ 6 months prior to the screening visit.
• Participant has ≥ 3 tender joints and ≥ 3 swollen joints at screening and Day 1 visits.
• Participant has at least one lesion of plaque psoriasis ≥ 2 cm in diameter, nail changes characteristic of psoriasis, or a documented history of plaque psoriasis.
• Participant has active PsA despite previous standard doses of non-steroidal anti-inflammatory drug (NSAIDs) administered for ≥ 4 weeks, or traditional disease-modifying anti-rheumatic drug (DMARDs) (including methotrexate and sulfasalazine) administered for ≥ 3 months, or tumor necrosis factor inhibitor (TNFi) agents administered for ≥ 3 months, or participants are intolerant to NSAIDs or DMARDs or TNFi agents.
• If participant is on concurrent PsA treatments, they must be on stable doses.
• All female participants should followed the protocol defined contraceptive method.

You may not qualify if:

• Participant has other disease(s) that might confound the evaluations of benefit of NDI-034858 therapy, including but not limited to rheumatoid arthritis (RA), axial spondyloarthritis (this does not include a primary diagnosis of PsA with spondylitis), systemic lupus erythematosus, Lyme disease, or fibromyalgia.
• Participant has a history of lack of response to any therapeutic agent targeting IL-12, IL17, and/or IL23 at approved doses after at least 12 weeks of therapy, and/or received one of these therapies within 6 months prior to baseline (Day 1).
• Participant has a history of lack of response to \> 1 therapeutic agent targeting tumor necrosis factor.
• Participant has received infliximab, golimumab, adalimumab, or certolizumab pegol, or any biosimilar of these agents, within 8 weeks prior to baseline (Day 1).
• Participant has received etanercept, or any biosimilar of etanercept, within 4 weeks prior to baseline (Day 1).
• Participant has received rituximab or any immune-cell-depleting therapy within 6 months prior to baseline (Day 1).
• Participant is currently receiving a non-biological investigational product or device or has received one within 4 weeks prior to baseline (Day 1).
• Participant has received intraarticular injection (including corticosteroids), intramuscular steroids, intralesional steroids, or intravenous steroids within 4 weeks prior to baseline (Day 1). For participants not receiving MTX and sulfasalazine at screening, MTX and sulfasalazine are excluded within 4 weeks prior to baseline (Day 1). For participants not receiving MTX and sulfasalazine at screening, MTX and sulfasalazine are excluded within 4 weeks prior to baseline (Day 1).
• Participant has received high potency opioid analgesics (eg, methadone, hydromorphone, or morphine) within 2 weeks prior to baseline (Day 1).
• Participant has used any topical medication that could affect PsA or psoriasis (including corticosteroids, retinoids, vitamin D analogues (such as calcipotriol), JAK inhibitors, or tar) within 2 weeks prior to baseline (Day 1).
• Participant has used any systemic treatment that could affect PsA or psoriasis (including oral retinoids, immunosuppressive/immunomodulating medication, cyclosporine, oral JAK inhibitors, or apremilast) within 4 weeks prior to baseline (Day 1).
• Participant has received any ultraviolet (UV)-B phototherapy (including tanning beds) or excimer laser within 4 weeks prior to baseline (Day 1).
• Participant has had psoralen and UV A (PUVA) treatment within 4 weeks prior to baseline (Day 1).
• Participant has received Chinese traditional medicine within 4 weeks prior to baseline (Day 1)
• Participant has received any live-attenuated vaccine, including for COVID-19, within 4 weeks prior to baseline (Day 1) or plans to receive a live-attenuated vaccine during the study and up to 4 weeks or 5 half-lives of the study drug, whichever is longer, after the last study drug administration.

Sponsors & Collaborators

• Takeda: lead
• Nimbus Lakshmi, Inc.: collaborator

Study Sites (56)

Nimbus site #XYZ

Palm Desert, California, 92260, United States

Location

Nimbus site #XYZ

Upland, California, 91786, United States

Location

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Hollywood, Florida, 33024, United States

Location

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Plantation, Florida, 33324, United States

Location

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St. Petersburg, Florida, 33705, United States

Location

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Tampa, Florida, 33613, United States

Location

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Tampa, Florida, 33614, United States

Location

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Winter Park, Florida, 32789, United States

Location

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Zephyrhills, Florida, 33542, United States

Location

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Indianapolis, Indiana, 46250, United States

Location

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West Des Moines, Iowa, 50265, United States

Location

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Lake Charles, Louisiana, 70605, United States

Location

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Worcester, Massachusetts, 01605, United States

Location

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Albuquerque, New Mexico, 87102, United States

Location

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Charlotte, North Carolina, 28210, United States

Location

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Duncansville, Pennsylvania, 16635, United States

Location

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Columbia, South Carolina, 29204, United States

Location

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Jackson, Tennessee, 38305, United States

Location

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Baytown, Texas, 77521, United States

Location

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Corpus Christi, Texas, 78404, United States

Location

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Houston, Texas, 77089, United States

Location

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Mesquite, Texas, 75150, United States

Location

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Beckley, West Virginia, 25801, United States

Location

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Hlučín, Ostrava-město, 748 01, Czechia

Location

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Prague, Praha 3, 130 00, Czechia

Location

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Ostrava, 702 00, Czechia

Location

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Pardubice, 530 02, Czechia

Location

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Uherské Hradiště, 686 01, Czechia

Location

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Zlín, 760 01, Czechia

Location

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Cottbus, Brandenburg, 03042, Germany

Location

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Bonn, North Rhine-Westphalia, 53127, Germany

Location

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Cologne, North Rhine-Westphalia, 50937, Germany

Location

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Herne, North Rhine-Westphalia, 44649, Germany

Location

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Ratingen, North Rhine-Westphalia, 40878, Germany

Location

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Berlin, 12161, Germany

Location

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Berlin, 14059, Germany

Location

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Hamburg, 20095, Germany

Location

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Hamburg, 22415, Germany

Location

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Krakow, Lesser Poland Voivodeship, 30-033, Poland

Location

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Lublin, Lublin Voivodeship, 20-607, Poland

Location

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Elblag, Warmian-Masurian Voivodeship, 82-300, Poland

Location

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Bialystok, 15-077, Poland

Location

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Bydgoszcz, 85-065, Poland

Location

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Krakow, 30-149, Poland

Location

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Krakow, 30-363, Poland

Location

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Nadarzyn, 05-830, Poland

Location

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Nowa Sól, 67-100, Poland

Location

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Poznan, 60-218, Poland

Location

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Poznan, 61-293, Poland

Location

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Poznan, 61-397, Poland

Location

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Poznan, 61-731, Poland

Location

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Sochaczew, 96-500, Poland

Location

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Torun, 87-100, Poland

Location

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Warsaw, 02-665, Poland

Location

Nimbus site #XYZ

Wroclaw, 50-244, Poland

Location

Nimbus site #XYZ

Wroclaw, 51-318, Poland

Location

Related Links

• To obtain more information on the study, click here/on this link

MeSH Terms

Conditions

Arthritis, Psoriatic

Condition Hierarchy (Ancestors)

Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Study Director
• Organization: Takeda

TrialDisclosures@takeda.com

+1-877-825-3327

Study Officials

• Medical Director

  Takeda

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Treatment and randomization information will be kept confidential and will not be released to the investigator, the study staff, the contract research organization (CRO), or the sponsor's study team until after the conclusion of the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2021
• First Posted: December 10, 2021
• Study Start: January 6, 2022
• Primary Completion: May 4, 2023
• Study Completion: June 2, 2023
• Last Updated: May 31, 2024
• Results First Posted: May 31, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Access Criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.

Locations

CZ (6); DE (9); PL (18); US (23)