Anemia Clinical Trials

• Participants must meet all the following criteria at screening (unless otherwise specified) to be eligible for enrollment in the study:

• Aged ≥18 years at the time of signing informed consent.

• Established diagnosis of IBD (CD, UC, or IBD-unclassified) based on documented findings on both endoscopy and histopathology.

• Baseline endoscopy at screening with modified Mayo Score for UC and CDAI for Crohn's Disease to include mild disease as defined below:

• a. CDAI of \<220 and SES-CD of 0 to 6 (CD/IBD-unclassified) modified Mayo Score of \<5 points and Mayo endoscopic subscore of 0 to 1 (UC/IBD-unclassified).

• Are symptomatic from anemia as assessed by the Investigator despite optimized, stable conventional IBD-directed therapy for 3 months.

• Hgb ≥7 AND \<12 g/dL for females and ≥7 AND \<13 g/dL for males (local lab) at screening.

• Have symptomatic anemia defined as:

∙ Hgb ≤10 g/dL and symptomatic as assessed by Investigator (fatigue, shortness of breath at rest or on minimal exertion, palpitations, tachycardia, orthostatic hypotension or dizziness), or

‣ Hgb \>10 g/dL and a minimum score of 4 on the Numeric Rating Scale for Fatigue.

• Serum ferritin ≥75 μg/L at screening (local lab).

• AST and ALT \<2× upper limit of normal (ULN) at screening.

• Total and direct bilirubin \<ULN at screening.

⁃ Estimated glomerular filtration rate ≥30 mL/min/1.73 m2 by the Chronic Kidney Disease-Epidemiology Collaboration (CKD-EPI) formula.

⁃ If female, then EITHER postmenopausal (defined as at least 12 months of spontaneous amenorrhea, 6 months of spontaneous amenorrhea with serum follicle-stimulating hormone (FSH) \>40 mIU/mL, or at least 6 weeks following surgical bilateral oophorectomy with or without hysterectomy), surgically sterile, OR agreeable to use 1 of the following highly effective contraception methods (listed below) during the study and for at least 8 weeks after the last dose of study drug:

∙ Stable hormonal contraceptive (≥3 months)

‣ Intrauterine device in place for at least 3 months

‣ Tubal ligation or single male partner with vasectomy

⁃ If a male with female sexual partner(s) of childbearing potential, agrees to use 1 of the following highly effective methods of contraception during the study and for at least 8 weeks after the last study drug dose:

∙ Stable hormonal contraceptive (≥3 months; female partner)

‣ Intrauterine device in place for at least 3 months (female partner)

‣ Surgically sterile by hysterectomy, bilateral oophorectomy, or bilateral tubal ligation (female partner)

‣ Confirmed successful vasectomy

⁃ Able to understand and provide written informed consent.

⁃ Able to comply with all study procedures.