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

Completed · Phase 2 · Has a placebo group

Conditions studied: Psoriatic Arthritis

In brief

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

Key facts

Study ID

NCT05153148

Run by

Takeda

People needed

305

Starts

2022-01-06

Expected to finish

2023-06-02

Last updated by the study team

2024-05-31

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

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 has received any marketed or investigational biological agent, other than those specified in other inclusion/exclusion criteria, within 12 weeks or 5 half-lives 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 apremilast or other non-biologic systemic treatment for PsA within 4 weeks prior to baseline (Day 1), other than methotrexate (MTX), sulfasalazine, corticosteroids, NSAIDs, or paracetamol/acetaminophen, which are allowed at stable doses as described in Inclusion Criterion 7. 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 leflunomide within 8 weeks of baseline (Day 1) if no elimination procedure was followed or adhere to an elimination procedure. 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 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.
• Participant is currently being treated with strong or moderate cytochrome P450 3A (CYP3A4) inhibitors, such as itraconazole or has received moderate or strong CYP3A4 inhibitors within 4 weeks prior to baseline (Day 1).
• Participant has consumed grapefruit or grapefruit juice within 1 week prior to baseline (Day 1).
• Participant has used tanning booths within 4 weeks prior to baseline (Day 1), has had excessive sun exposure, or is not willing to minimize natural and artificial sunlight exposure during the study.
• Participant is a female who is breastfeeding, pregnant, or who is planning to become pregnant during the study.
• Participant has evidence of erythrodermic, pustular, predominantly guttate psoriasis, or drug-induced psoriasis.
• Participant has any clinically significant medical condition, evidence of an unstable clinical condition, psychiatric condition, or vital signs/physical/laboratory/ECG abnormality that would, in the opinion of the investigator, put the participant at undue risk or interfere with interpretation of study results.
• Participant had a major surgery within 8 weeks prior to baseline (Day 1 or has a major surgery planned during the study.
• Participant has a history of Class III or IV congestive heart failure as defined by New York Heart Association Criteria.

Where it is running

• Nimbus site #XYZ — Upland, California, United States
• Nimbus site #XYZ — Hollywood, Florida, United States
• Nimbus site #XYZ — Plantation, Florida, United States
• Nimbus site #XYZ — St. Petersburg, Florida, United States
• Nimbus site #XYZ — Tampa, Florida, United States
• Nimbus site #XYZ — Tampa, Florida, United States
• Nimbus site #XYZ — Winter Park, Florida, United States
• Nimbus site #XYZ — Zephyrhills, Florida, United States
• Nimbus site #XYZ — Indianapolis, Indiana, United States
• Nimbus site #XYZ — West Des Moines, Iowa, United States
• Nimbus site #XYZ — Lake Charles, Louisiana, United States
• Nimbus site #XYZ — Worcester, Massachusetts, United States
• Nimbus site #XYZ — Albuquerque, New Mexico, United States
• Nimbus site #XYZ — Charlotte, North Carolina, United States
• Nimbus site #XYZ — Duncansville, Pennsylvania, United States
• Nimbus site #XYZ — Columbia, South Carolina, United States
• Nimbus site #XYZ — Jackson, Tennessee, United States
• Nimbus site #XYZ — Baytown, Texas, United States
• Nimbus site #XYZ — Corpus Christi, Texas, United States
• Nimbus site #XYZ — Houston, Texas, United States
• Nimbus site #XYZ — Mesquite, Texas, United States
• Nimbus site #XYZ — Beckley, West Virginia, United States
• Nimbus site #XYZ — Hlučín, Ostrava-město, Czechia
• Nimbus site #XYZ — Prague, Praha 3, Czechia
• Nimbus site #XYZ — Palm Desert, California, United States

Full record on ClinicalTrials.gov

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