A study to evaluate the efficacy, safety, and tolerability of NDI-034858 compared to placebo in subjects with active psoriatic arthritis
- Conditions
- Psoriatic ArthritisMedDRA version: 21.0Level: LLTClassification code 10037160Term: Psoriatic arthritisSystem Organ Class: 100000004859Therapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- EUCTR2021-005888-52-CZ
- Lead Sponsor
- imbus Lakshmi, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 290
1. Subject is male or female, aged =18 years, at the time of consent.
2. Subject has PsA on the basis of the CASPAR with peripheral symptoms at the screening visit, as assessed by the investigator.
3. Subject has PsA symptoms for = 6 months prior to screening, as assessed by the investigator.
4. Subject has = 3 tender joints and = 3 swollen joints at screening and Day 1 visits, as assessed by the investigator.
5. Subject has at least one lesion of plaque psoriasis = 2 cm in diameter, nail changes characteristic of psoriasis, or a documented history of plaque psoriasis.
6. Subject has active PsA despite previous standard doses of NSAIDs administered for = 4 weeks, or traditional DMARDs (including methotrexate and sulfasalazine) administered for = 3 months, or TNFi agents administered for = 3 months, or subjects are intolerant to NSAIDs or DMARDs or TNFi agents, as assessed by the investigator.
7. If subject is on concurrent PsA treatments, they must be on stable doses as described below and for the duration of the study:
a. Methotrexate (MTX): subject must have received treatment for = 3 months, with stable dose and stable route of administration (not to exceed 25 mg MTX per week) for = 4 weeks prior to Day 1 until Week 16 (EOS); subjects on MTX should be taking folic acid supplementation according to local standard of care to minimize the likelihood of MTX associated toxicity.
b. Sulfasalazine: Maximum dose of 3 gm/day. Minimum duration of therapy 2 months and dose stable for 4 weeks prior to Day 1.
c. Other traditional DMARDs not listed may be considered on a case-by-case basis after discussion with the medical monitor.
d. Oral corticosteroids: the subject must be on a stable dose, not to exceed the equivalent of 10 mg of prednisone per day, for = 2 weeks prior to Day 1. If subject is not currently using oral corticosteroids, must not have received for at least 2 weeks prior to Day 1.
a. NSAIDs or paracetamol/acetaminophen as needed: the subject must be on a stable dose for = 2 weeks prior to Day 1. If not currently using NSAIDs, must not have received for at least 2 weeks prior to Day 1.
8. For female subjects of childbearing potential involved in any sexual intercourse that could lead to pregnancy: the subject must agree to use a highly effective contraceptive method from screening until at least 4 weeks after the last study drug administration. Highly effective contraceptive methods include hormonal contraceptives (eg, combined oral contraceptive, patch, vaginal ring, injectable, or implant), intrauterine devices or intrauterine systems, vasectomized partner(s) (provided vasectomy was performed = 4 months prior to screening), tubal ligation, or double barrier methods of contraception (eg, male condom with cervical cap, male condom with diaphragm, and male condom with contraceptive sponge) in conjunction with spermicide.
9. Female subjects of childbearing potential must have had a negative serum pregnancy test at screening and negative urine pregnancy test at Day 1.
10. For male subjects involved in any sexual intercourse that could lead to pregnancy, subject must agree to use one of the highly effective contraceptive methods listed in Inclusion Criterion 9, from Day 1 until at least 12 weeks after the last study drug administration. If the female partner of a male subject uses any of the hormonal contraceptive methods listed above, this contraceptive method should be used by the female partner from at least 4 weeks before Day 1 unt
1. Other disease(s) that might confound the evaluations of benefit of NDI-034858 therapy, including but not limited to rheumatoid arthritis, axial spondyloarthritis (this does not include a primary diagnosis of PsA with spondylitis), systemic lupus erythematosus, Lyme disease or fibromyalgia.
2. History of lack of response to any therapeutic agent targeting interleukin (IL)-12, IL-17, and/or IL-23 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).
3. History of lack of response to >1 therapeutic agent targeting tumor necrosis factor.
4. Received infliximab, golimumab, adalimumab, or certolizumab pegol, or any biosimilar of these agents, within 8 weeks or 5 half-lives, whichever is longer, prior to baseline (Day 1).
5. Received etanercept, or any biosimilar of etanercept, within 4 weeks prior to baseline (Day 1).
6. Received rituximab or any immune-cell-depleting therapy within 6 months prior to baseline (Day 1).
7. Received any marketed or investigational biological agent, other than those specified in other inclusion/exclusion criteria, within 12 weeks or 5 half-lives (whichever is longer) prior to baseline (Day 1).
8. Currently receiving a non-biological investigational product or device or has received one within 4 weeks prior to baseline (Day 1).
9. Received apremilast or other non-biologic systemic treatment for PsA within 4 weeks prior to baseline (Day 1), other than MTX, sulfasalazine, corticosteroids, NSAIDs, or paracetamol/acetaminophen, which are allowed at stable doses as described in Inclusion Criterion 7. Subject has received leflunomide within 95 days of baseline (Day 1) if no elimination procedure was followed or adhere to an elimination procedure (eg, 11 days with cholestyramine or 30 days washout with activated charcoal as per local label). For subjects not receiving MTX and sulfasalazine at Screening, MTX and sulfasalazine are excluded within 4 weeks prior to baseline (Day 1).
10. Received intraarticular injection (including corticosteroids), intramuscular steroids, intralesional steroids, or intravenous steroids within 4 weeks prior to baseline (Day 1). For subjects not receiving MTX and sulfasalazine at screening, MTX and sulfasalazine are excluded within 4 weeks prior to baseline (Day 1).
11. Received high potency opioid analgesics (eg, methadone, hydromorphone, or morphine) within 2 weeks prior to baseline (Day 1).
12. Used any topical medication that could affect PsA or psoriasis (including corticosteroids, retinoids, vitamin D analogues [such as calcipotriol], Janus kinase [JAK] inhibitors, or tar) within 2 weeks prior to baseline (Day 1).
13. 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), unless otherwise excluded or allowed by protocol.
14. Received any ultraviolet (UV)-B phototherapy (including tanning beds) or excimer laser within 4 weeks prior to baseline (Day 1).
15. Had psoralen and ultraviolet A (PUVA) treatment within 4 weeks prior to baseline (Day 1).
16. Received Chinese traditional medicine within 4 weeks prior to baseline (Day 1).
17. Received any live-attenuated vaccine, including for Coronavirus Disease-19 (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 wee
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To assess the efficacy of NDI-034858 orally administered QD at 5 mg, 15 mg, or 30 mg for 12 weeks on the rheumatological signs, symptoms and function in subjects with active psoriatic arthritis (PsA);Secondary Objective: · To assess additional evaluations of efficacy of NDI-034858 orally administered QD at 5 mg, 15 mg, or 30 mg for 12 weeks in subjects with active PsA<br>· To assess the safety and tolerability of NDI-034858 orally administered QD at 5 mg, 15 mg, or 30 mg for 12 weeks in subjects with active PsA<br>·To evaluate the plasma concentration of NDI-034858 orally administered QD at 5 mg, 15 mg, or 30 mg in subjects with active PsA<br>;Primary end point(s): Proportion of subjects achieving at least an American College of Rheumatology (ACR) 20 response at Week 12;Timepoint(s) of evaluation of this end point: For time-point(s) see section E.5.1
- Secondary Outcome Measures
Name Time Method