Study of NDI-034858 in Participants With Moderate to Severe Plaque Psoriasis

Inclusion Criteria

In order to be eligible to participate in this study, a participant must meet all of the following criteria, either at the screening and Day 1 visits or only at one of the specified visits (screening or Day 1) as noted in the criterion:

• Male or female participant aged 18 to 70 years, inclusive, at the time of consent.
• Participant has a history of plaque psoriasis for at least 6 months prior to the screening visit.
• Participant had no significant flare in psoriasis for at least 3 months before screening (information obtained from medical chart or participant's physician, or directly from the participant).
• Participant has moderate to severe plaque psoriasis as defined by a PASI score ≥ 12 and a PGA score ≥ 3 at screening and Day 1.
• Participant has plaque psoriasis covering ≥ 10% of his or her total BSA at screening and Day 1.
• Participant must be a candidate for phototherapy or systemic therapy.
• For female participants of childbearing potential involved in any sexual intercourse that could lead to pregnancy: the participant must agree to use a highly effective contraceptive method from at least 4 weeks prior to Day 1 until at least 4 weeks after the last study product 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), bilateral tubal ligation or occlusion, 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.
• Female participants of childbearing potential have had a negative serum pregnancy test at screening and negative urine pregnancy test at Day 1.
• For male participants involved in any sexual intercourse that could lead to pregnancy, participant must agree to use one of the highly effective contraceptive methods listed in Inclusion Criterion 6, from Day 1 until at least 12 weeks after the last study product administration. If the female partner of a male participant 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 until at least 12 weeks after the last study product administration.
• Participant has a BMI within the range of 18 to 42 kg/m2, inclusive (BMI = weight [kg]/[height (m)]2), and total body weight >50 kg (110 lb).
• Participant is willing to participate and is capable of giving informed consent. Note: Consent must be obtained prior to any study-related procedures.
• Participant must be willing to comply with all study procedures and must be available for the duration of the study.

Exclusion Criteria

A participant who meets any of the following criteria at the screening and/or Day 1 visits, as applicable, will be excluded from participation in this 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 a history of skin disease or presence of skin condition that, in the opinion of the investigator, would interfere with the study assessments.
• Participant has immune-mediated conditions commonly associated with psoriasis, such as psoriatic arthritis, uveitis, inflammatory bowel disease, that require systemic treatment (including corticosteroids, immunosuppressants, or biologics). Note: Participants with immune-mediated conditions that do not require systemic treatment may be included in the study. Certain therapies such as NSAIDs may be permitted, but should be discussed with the Medical Monitor prior to determination of participant eligibility.
• Participant has any clinically signi