Crohn's Disease Clinical Trials

• Male and females ≥ 18 and ≤ 65 years of age at time of consent.

• Weight of ≥ 40 kg.

• Medical history and biological evidence of active bowel inflammation documented by:

‣ Minimum of approximate 1 year of Crohn's disease diagnosis confirmed through Endoscopy, and;

⁃ Endoscopic evidence of CD diagnosis at least 3 months prior to and/or at Screening (SES-CD ≥ 6 for ilealcolonic or ≥ 4 isolated ileal disease by central reader)

• Active disease defined as moderate to severe active CD at Screening defined by all of the following:

‣ Evidence of mucosal inflammation, defined as SES-CD ≥ 6 (≥ 4 for subjects with isolated ileal disease), and;

⁃ CDAI total scores ≥ 220

• Subject on treatment with corticosteroids may be included if they meet the following:

‣ prednisone or equivalent dose ≤ 20 mg/day; or

⁃ budesonide ≤ 9 mg/day; or

⁃ has been on a stable dose for at least 7 days prior to TRX103 dose.

• Advanced therapy-refractory disease defined by:

• Failure of two or more advanced approved therapies. Prior therapies may be inclusive of any combination of the following:

⁃ TNF-alpha inhibitors

⁃ IL-12/23 inhibitors

⁃ Anti-integrins

⁃ JAK inhibitors Failure of therapies are defined as either non-response (primary failure), complete loss of response (secondary failure) or intolerant to therapy at a dose indicated for CD.

⁃ Primary failure is defined as:

• When a subject does not achieve a response after having received the induction doses of a CD approved drug per prescribing information. Induction period is defined as 12-weeks.

∙ A response is defined as CDAI score that reduces by ≥ 100-point from Baseline or by Physician assessment.

⁃ Secondary failure, or relapse defined as:

• Subjects who respond to the therapy or achieves remission after an induction regimen per prescribing information, but subsequently lose response or relapses during maintenance treatment.

∙ Relapse is defined as an increase in the CDAI score from maintenance of ≥ 100 points and a CDAI score \> 220, and/or SES-CD score ≥ 6 (or ≥ 4 if isolated ileal disease) or by Physician assessment.

⁃ Intolerant to therapy, defined as:

• When a subject is unable to cope with the side effects or mechanism of actions of the treatment and/or experiences unacceptable side effects when dosed at appropriate therapeutic levels.

• Absence of uncontrolled bacterial, viral, or fungal infection at time of enrollment.

• Subjects must be able to understand and sign informed consent and be willing and able to complete all specified procedures and visits.