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

A Phase 2b, Randomized, Multi-Center, Double-Blind, Placebo-Controlled, Multiple Dose Study to Evaluate the Efficacy, Safety, and Tolerability of NDI-034858 in Subjects With Active Psoriatic Arthritis

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

Study Overview

• Status: Completed
• Conditions: Psoriatic Arthritis
• Intervention / Treatment: Drug: NDI-034858; Other: Placebo

Detailed Description

This is a Phase 2b, Randomized, Multi-center, Double-Blind, Placebo-Controlled, Multiple Dose Study.

Randomization to one of the treatments with NDI-034858 Dose 1, 2, 3 or placebo once daily (QD) will be based on a 1:1:1:1 scheme.

The maximum study duration per participant is approximately 20 weeks, including up to 30 days for the screening period, a 12-week treatment period, and a 4-week safety follow-up period.

Efficacy will be assessed using the ACR20 composite measure (including tender and swollen joint count, patient assessment of PsA pain visual analog scale (VAS), patient global PsA assessment VAS, physician global PsA assessment, HAQ-DI, and hsCRP) as well as the additional components. Efficacy for psoriasis among participants who have ≥ 3% BSA) involvement on Day 1, will be measured using PASI, PGAs, and BSA.

Safety will be assessed by collecting AEs, recording vital signs, performing physical examinations, and evaluating clinical laboratory and ECGs results.

Blood samples will be collected to measure plasma concentrations of NDI-034858.

• Study Type: Interventional
• Enrollment (Actual): 387
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Study Coordinator; Phone Number: 857-999-2009; Email: clinical@nimbustx.com

Study Locations

• Czechia
  • Ostrava, Czechia, 702 00
    • Nimbus site #XYZ
  • Pardubice, Czechia, 530 02
    • Nimbus site #XYZ
  • Uherské Hradiště, Czechia, 686 01
    • Nimbus site #XYZ
  • Zlin, Czechia, 760 01
    • Nimbus site #XYZ
  • Ostrava-město
    • Hlučín, Ostrava-město, Czechia, 748 01
      • Nimbus site #XYZ
  • Praha 3
    • Praha, Praha 3, Czechia, 130 00
      • Nimbus site #XYZ
• Germany
  • Berlin, Germany, 12161
    • Nimbus site #XYZ
  • Berlin, Germany, 14059
    • Nimbus site #XYZ
  • Hamburg, Germany, 20095
    • Nimbus site #XYZ
  • Hamburg, Germany, 22415
    • Nimbus site #XYZ
  • Brandenburg
    • Cottbus, Brandenburg, Germany, 03042
      • Nimbus site #XYZ
  • Nordrhein-Westfalen
    • Bonn, Nordrhein-Westfalen, Germany, 53127
      • Nimbus site #XYZ
    • Cologne, Nordrhein-Westfalen, Germany, 50937
      • Nimbus site #XYZ
    • Herne, Nordrhein-Westfalen, Germany, 44649
      • Nimbus site #XYZ
    • Ratingen, Nordrhein-Westfalen, Germany, 40878
      • Nimbus site #XYZ
• Poland
  • Bialystok, Poland, 15-077
    • Nimbus site #XYZ
  • Bydgoszcz, Poland, 85-065
    • Nimbus site #XYZ
  • Krakow, Poland, 30-363
    • Nimbus site #XYZ
  • Kraków, Poland, 30-149
    • Nimbus site #XYZ
  • Nadarzyn, Poland, 05-830
    • Nimbus site #XYZ
  • Nowa Sol, Poland, 67-100
    • Nimbus site #XYZ
  • Poznan, Poland, 60-218
    • Nimbus site #XYZ
  • Poznan, Poland, 61-293
    • Nimbus site #XYZ
  • Poznań, Poland, 61-397
    • Nimbus site #XYZ
  • Poznań, Poland, 61-731
    • Nimbus site #XYZ
  • Sochaczew, Poland, 96-500
    • Nimbus site #XYZ
  • Torun, Poland, 87-100
    • Nimbus site #XYZ
  • Warszawa, Poland, 02-665
    • Nimbus site #XYZ
  • Wroclaw, Poland, 50-244
    • Nimbus site #XYZ
  • Wroclaw, Poland, 51-318
    • Nimbus site #XYZ
  • Lubelskie
    • Lublin, Lubelskie, Poland, 20-607
      • Nimbus site #XYZ
  • Malopolskie
    • Kraków, Malopolskie, Poland, 30-033
      • Nimbus site #XYZ
  • Warminsko-mazurskie
    • Elblag, Warminsko-mazurskie, Poland, 82-300
      • Nimbus site #XYZ
• United States
  • California
    • Palm Desert, California, United States, 92260
      • Nimbus site #XYZ
    • Upland, California, United States, 91786
      • Nimbus site #XYZ
  • Florida
    • Hollywood, Florida, United States, 33024
      • Nimbus site #XYZ
    • Plantation, Florida, United States, 33324
      • Nimbus site #XYZ
    • Saint Petersburg, Florida, United States, 33705
      • Nimbus site #XYZ
    • Tampa, Florida, United States, 33613
      • Nimbus site #XYZ
    • Tampa, Florida, United States, 33614
      • Nimbus site #XYZ
    • Winter Park, Florida, United States, 32789
      • Nimbus site #XYZ
    • Zephyrhills, Florida, United States, 33542
      • Nimbus site #XYZ
  • Indiana
    • Indianapolis, Indiana, United States, 46250
      • Nimbus site #XYZ
  • Iowa
    • West Des Moines, Iowa, United States, 50265
      • Nimbus site #XYZ
  • Louisiana
    • Lake Charles, Louisiana, United States, 70605
      • Nimbus site #XYZ
  • Massachusetts
    • Worcester, Massachusetts, United States, 01605
      • Nimbus site #XYZ
  • New Mexico
    • Albuquerque, New Mexico, United States, 87102
      • Nimbus site #XYZ
  • North Carolina
    • Charlotte, North Carolina, United States, 28210
      • Nimbus site #XYZ
  • Pennsylvania
    • Duncansville, Pennsylvania, United States, 16635
      • Nimbus site #XYZ
  • South Carolina
    • Columbia, South Carolina, United States, 29204
      • Nimbus site #XYZ
  • Tennessee
    • Jackson, Tennessee, United States, 38305
      • Nimbus site #XYZ
  • Texas
    • Baytown, Texas, United States, 77521
      • Nimbus site #XYZ
    • Corpus Christi, Texas, United States, 78404
      • Nimbus site #XYZ
    • Houston, Texas, United States, 77089
      • Nimbus site #XYZ
    • Mesquite, Texas, United States, 75150
      • Nimbus site #XYZ
  • West Virginia
    • Beckley, West Virginia, United States, 25801
      • Nimbus site #XYZ

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.
• Participant has an estimated creatinine clearance of < 40 mL/min based on the Cockcroft-Gault equation or a history of renal failure.
• Participant was hospitalized in the 3 months prior to screening for asthma, has ever required intubation for treatment of asthma, currently require oral corticosteroids for the treatment of asthma, or has required more than one short-term (≤ 2 weeks) course of oral corticosteroids for asthma within 6 months prior to baseline (Day 1).
• Participant has a history of cancer or lymphoproliferative disease within 5 years prior to baseline (Day 1). Participants with successfully treated nonmetastatic cutaneous squamous cell or basal cell carcinoma and/or localized carcinoma in situ of the cervix are not to be excluded.
• Participant has a history of fever, inflammation, or systemic signs of illness suggestive of systemic or invasive infection within 4 weeks prior to baseline (Day 1).
• Participant has an active bacterial, viral, fungal, mycobacterial infection, or other infection (including TB or atypical mycobacterial disease), or any major episode of infection that required hospitalization or treatment with intravenous antibiotics within 12 weeks prior to baseline (Day 1), or oral antibiotics within 4 weeks prior to baseline (Day 1).
• Participant has a history of chronic or recurrent infectious disease, including but not limited to chronic renal infection, chronic chest infection, recurrent urinary tract infection, fungal infection (with the exception of superficial fungal infection of the nailbed), or infected skin wounds or ulcers.
• Participant has a history of an infected joint prosthesis or has received antibiotics for a suspected infection of a joint prosthesis, if that prosthesis has not been removed or replaced.
• Participant has active herpes infection, including herpes simplex 1 and 2 and herpes zoster within 8 weeks prior to Day 1.
• Participant has a history of known or suspected congenital or acquired immunodeficiency state or condition that would compromise the Participant's immune status (eg, history of splenectomy, primary immunodeficiency).
• Participant has positive results for hepatitis B surface antigens (HBsAg), antibodies to hepatitis B core antigens (anti-HBc), hepatitis C virus (HCV), or human immunodeficiency virus (HIV). Samples testing positive for HCV antibodies will require polymerase chain reaction (PCR) qualitative testing for HCV RNA.
• Participant has clinical or laboratory evidence of active or latent TB infection at screening as assessed by QuantiFERON-TB Gold (or a purified protein derivative [PPD] skin test or equivalent, or both if required per local guidelines) and chest X-ray. The PPD skin test should be utilized only when a QuantiFERON-TB Gold Test is not possible for any reason (unless local guidelines require both tests). Chest X-ray may be taken at screening or completed within 3 months prior to the screening visit, with documentation showing no evidence of infection or malignancy as read by a qualified physician.
• Participant has a known or suspected allergy to NDI-034858 or any component of the investigational product, or any other significant drug allergy (such as anaphylaxis or hepatotoxicity).
• Participant has a known history of clinically significant drug or alcohol abuse in the last year prior to baseline (Day 1).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NDI-034858 study drug - Dose 1; NDI-034858 study drug will be orally administered QD for 12 weeks	Drug: NDI-034858; Randomized participants will receive NDI-034858 capsule orally; Other Names: TAK-279
Experimental: NDI-034858 study drug - Dose 2; NDI-034858 study drug will be orally administered QD for 12 weeks	Drug: NDI-034858; Randomized participants will receive NDI-034858 capsule orally; Other Names: TAK-279
Experimental: NDI-034858 study drug - Dose 3; NDI-034858 study drug will be orally administered QD for 12 weeks	Drug: NDI-034858; Randomized participants will receive NDI-034858 capsule orally; Other Names: TAK-279
Placebo Comparator: Placebo; Placebo will be orally administered QD for 12 weeks	Other: Placebo; Randomized participants will receive placebo orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of participants achieving at least an American College of Rheumatology (ACR) 20 response	The ACR20 is a composite measure defined as both improvement of 20% in the number of tender (68) and number of swollen (66) joints, and a 20% improvement in three of the following five criteria: patient global assessment of psoriatic arthritis, physician global assessment of psoriatic arthritis, patient pain scale, disability history questionnaire (ie, HAQ-DI) and an acute phase reactant (ie, erythrocyte sedimentation rate [ESR] or hsCRP). For this primary endpoint, hsCRP will be used.	At Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of participants achieving at least an ACR-50 or ACR-70 response	The ACR-50 and ACR-70 are a composite measure defined as both improvement of 50% or 70%, respectively, in the number of tender (68) and number of swollen (66) joints, and a 50% or 70%, respectively, improvement in three of the following five criteria: patient global assessment of psoriatic arthritis, physician global assessment of psoriatic arthritis, patient pain scale, disability history questionnaire (ie, HAQ-DI) and an acute phase reactant (ie, ESR or CRP).	At Week 12
Change from baseline in tender joint count (TJC)	The TJC 68 are a total score of points assigned for presence of tenderness in the following: Temporomandibular, sternoclavicular, acromioclavicular, shoulder, elbow, wrist, hip, knee, ankle, tarsus, typically assigned 2 points each; Metacarpophalangeal, finger proximal interphalangeal, metatarsophalangeal, toe proximal interphalangeal, typically assigned 10 points each; Distal interphalangeal, typically assigned 8 points.	Baseline (Day 1), Week 12
Change from baseline in swollen joint count (SJC)	The SJC 66 (SJC minus hip joints, which cannot be assessed for swelling) are a total score of points assigned for presence of swelling in the following: Temporomandibular, sternoclavicular, acromioclavicular, shoulder, elbow, wrist, knee, ankle, tarsus, typically assigned 2 points each; Metacarpophalangeal, finger proximal interphalangeal, metatarsophalangeal, toe proximal interphalangeal, typically assigned 10 points each; Distal interphalangeal, typically assigned 8 points.	Baseline (Day 1), Week 12
Change from baseline in Patient Global Assessment of Psoriatic Arthritis	Participants will rate their assessment of their PsA using a VAS where 0 is 'very good, no symptoms' and 100 is 'very poor, severe symptoms'.	Baseline (Day 1), Week 12
Change from baseline in Patient Global Assessment of Psoriatic Arthritis pain	Participants will rate their assessment of their PsA using a VAS where 0 is 'no pain' and 100 is 'most severe pain'.	Baseline (Day 1), Week 12
Change from baseline in Physician Global Assessment of Psoriatic Arthritis	The participants' overall disease status will be assessed, taking into account signs, symptoms, and function, of all components of joint and skin which is affected at the time of the visit and will rate this overall status using a VAS scale where 0 is 'very good, asymptomatic, and no limitation of normal activities' and 100 is 'very poor, very severe symptoms which are intolerable, and inability to carry out all normal activities'.	Baseline (Day 1), Week 12
Change from baseline in Health Activities Questionnaire - Disability Index (HAQ-DI) score	The HAQ-DI is comprised of eight domains: dressing, arising, eating, walking, hygiene, reach, grip, and activities. There are two or three questions per section. Scoring within each section is from 0 (without any difficulty) to 3 (unable to do). For each section the score given to that section is the worst score within the section (ie, if one question is scored 1 and another 2, then the score for the section is 2).	Baseline (Day 1), Week 12
Change from baseline in dactylitis count	The dactylitis count consists of totaling the number of single digits in the hands and feet with tenderness.	Baseline (Day 1), Week 12
Change from baseline in Leed's Enthesitis Index (LEI)	The LEI is comprised of review of six bilateral sites: Achilles tendon insertions, medial femoral condyles, and lateral epicondyles of the humerus. Tenderness at each site is quantified on a dichotomous basis: 0 means nontender and 1 means tender.	Baseline (Day 1), Week 12
Proportion of Participants With Minimal Disease Activity (MDA)	The MDA criteria assess 7 domains: number of tender joints (0-68), number of swollen joints (0-66), visual analogue scale (VAS) for pain (0-100 mm, 100 mm=most pain), VAS for patient's global assessment (0-100 mm, 100 mm=worst score), tender entheseal point and Psoriasis Area and Severity Index(PASI)/body surface area(BSA). Functional disability is assessed by the Health Assessment Questionnaire (HAQ) (0-3=most functional disability). The MDA criteria have the following cutoffs: tender joint count less than and equal to (<=) 1, swollen joint count <=1, enthesitis count <=1, PASI <=1 (or BSA <=3%), function score <=0.5 (measured by the HAQ), patient's global assessment ,<=20 and patient-reported pain <=15 on a 100-mm VAS. If 5 of the 7 cutoffs for these domains are met, then the participant is classified as having MDA.	At Week 12
Change From Baseline in Disease Activity Index for Psoriatic Arthritis (DAPSA)	The DAPSA score is a composite score calculated using scores from TJC of 68 joints and SJC of 66 joints, patient's global assessment of PsA and patient's global assessment of PsA pain scores on a VAS, and the high sensitivity C-reactive protein (hsCRP) level. The total scores ranges from 0 to 50. A DAPSA score of 5-14 represents a state of low disease activity and a score of <=4 represents remission.	Baseline (Day 1), Week 12
Proportion of Participants Achieving 75% Improvement From Baseline in Psoriasis Area Severity Index (PASI-75) at Week 12	The PASI is a composite score ranging from 0 to 72 that takes into account the degree of erythema, induration/infiltration, and desquamation (each scored from 0 to 4 separately) for each of four body regions, with adjustments for the percentage of BSA involved for each body region and for the proportion of the body region to the whole body. Higher score means worse outcome. Proportion of participants achieving 75% improvement from baseline in PASI-75 among participants with >= 3% BSA psoriatic involvement at Day 1 will be reported.	Baseline (Day 1), Week 12
Proportion of Participants Achieving a Physician Global Assessment of Psoriasis of 0 or 1 and at least a 2-point Improvement From Baseline at Week 12	The PGA is measured using a 0 to 4 scale with a 0 score meaning cleared and a 4 score meaning severe and a ≥ 2 grade improvement from baseline.	Baseline (Day 1), Week 12
Number of Participants with Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs and Treatment-emergent Adverse Events of Special Interests (TEAESIs)	TEAEs are defined as adverse events (AEs) with onset at the time of or following the first exposure to NDI-034858 in this study, or medical conditions present prior to the start of treatment but increasing in severity or relationship at the time of or following the start of treatment. Serious TEAEs are defined as any untoward clinical manifestation of signs, symptoms, outcomes (related to Investigational product [IP] or not) that at any dose: resulted in death, was life-threatening, required inpatient/prolongation of hospitalization, resulted in persistent/significant disability/incapacity, congenital abnormality/birth defect, important medical event. TEAESIs are defined as investigator-reported hypersensitivity reactions, events of disordered coagulation as bleeding/hypercoagulable. Relatedness to study drug was based on Investigator's discretion.	Baseline (Day 1) up to End of study (EOS) (Week 16)
Plasma Concentrations of NDI-034858	Plasma concentrations of NDI-034858 will be assessed.	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

Collaborators and Investigators

• Sponsor: Takeda
• Collaborators: Nimbus Lakshmi, Inc.
• Investigators: Study Director: Study Director, Takeda

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): January 6, 2022
• Primary Completion (Actual): June 2, 2023
• Study Completion (Actual): June 2, 2023

Study Registration Dates

• First Submitted: November 26, 2021
• First Submitted That Met QC Criteria: December 9, 2021
• First Posted (Actual): December 10, 2021

Study Record Updates

• Last Update Posted (Actual): March 19, 2024
• Last Update Submitted That Met QC Criteria: March 15, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Double-blind; Placebo-Controlled; Multiple-dose study
• Additional Relevant MeSH Terms: Skin Diseases; Joint Diseases; Musculoskeletal Diseases; Skin Diseases, Papulosquamous; Spinal Diseases; Bone Diseases; Spondylarthropathies; Spondylarthritis; Spondylitis; Psoriasis; Arthritis; Arthritis, Psoriatic
• Other Study ID Numbers: 4858-202; 2021-005888-52 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No