Drug Trials Snapshots: OMVOH

How were the trials designed?

UC-1 was a multicenter, randomized, double-blind, parallel-arm, placebo-controlled trial designed to evaluate the safety and efficacy of OMVOH, compared with placebo, over a 12-week induction period. The trial population included patients with moderately to severely active UC who had an inadequate response, loss of response, or failed to tolerate any of the following: corticosteroids, immunomodulators (6-mercaptopurine, azathioprine), biologic therapy (tumor necrosis factor [TNF] blocker, vedolizumab), or tofacitinib. A total of 1,062 patients from 35 countries were randomized with a 3:1 ratio to receive blinded OMVOH 300 mg IV or placebo every four weeks at Weeks 0, 4, and 8. The primary efficacy endpoint was the proportion of patients in clinical remission at Week 12.

UC-2 was a multicenter, randomized, double-blind, parallel-arm, placebo-controlled study designed to evaluate the safety and efficacy of OMVOH, compared with placebo, in achieving remission of UC at Week 40 in patients who completed the 12-week induction trial UC-1. A total of 544 subjects entered UC-2 and were randomized with a 2:1 ratio to receive blinded OMVOH 300 mg SC or placebo every four weeks. The primary efficacy endpoint was the proportion of patients in clinical remission at Week 40.

Who participated in the trials?

Table 1. Baseline Demographics in Efficacy Population

Source: Adapted from FDA Review

What are the benefits of this drug (results of trials used to assess efficacy)?

Efficacy results for the primary analysis of clinical remission are presented in Table 2 (UC-1 at Week 12) and Table 3 (UC-2 at Week 40).

For the primary endpoint of clinical remission at Week 12 in UC-1, patients who received OMVOH 300 mg IV had a statistically significant higher rate of clinical remission than patients who received placebo.

For the primary endpoint of clinical remission at Week 40 in UC-2, patients who received OMVOH 200 mg SC had a statistically significant higher rate of clinical remission than patients who received placebo.

Table 2. Clinical Remission at Week 12, UC-1

Source: Adapted from FDA Review
Abbreviations: CI, confidence interval; IV, intravenous; N, number of subjects in treatment group; Q4W, once every four weeks

Table 3. Clinical Remission at Week 40, UC-2

Source: Adapted from FDA Review
Abbreviations: CI, confidence interval; N, number of subjects in treatment group; Q4W, once every four weeks; SC, subcutaneous

Were there any differences in how well the drug worked in clinical trials among sex, race, and age groups?

Subgroup analyses were conducted to assess the potential for differences in the treatment effect for various demographics. Table 4 and Table 5 summarize efficacy results by age, sex, race, and ethnicity for UC-1 and UC-2, respectively. Overall, the treatment effect of OMVOH compared to placebo appeared consistent across demographic subgroups of sex. However, there was an insufficient number of patients of races other than White and Asian, Hispanic or Latino ethnicity, and older than 65 years of age to determine whether OMVOH worked differently in other races, ethnicities, or older adults, respectively.

Table 4. Clinical Remission at Week 12 by Sex, Age, Race, and Ethnicity, UC-1

Source: Adapted from FDA Review
¹ Black or African American, Native Hawaiian or Other Pacific Islander, American Indian or Alaska Native, and Multiracial people
Abbreviation: N, number of subjects in the subgroup; Q4W, once every 4 weeks; IV, intravenous; CI, confidence interval

Table 5. Clinical Remission at Week 40 by Sex, Age, Race, and Ethnicity, UC-2

Source: Adapted from FDA Review
¹ Black or African American, Native Hawaiian or Other Pacific Islander, American Indian or Alaska Native, and Multiracial people
Abbreviation: N, number of subjects in the subgroup; Q4W, once every 4 weeks; IV, intravenous; CI, confidence interval

What are the possible side effects (results of trials used to assess safety)?

A summary of adverse reactions reported during UC-1 is provided in Table 6, and UC-2 provided in Table 7.

Table 6. Adverse Reactions1 by Week 12, UC-1

Source: OMVOH Prescribing Information
¹ Reported in at least 2% of subjects and at a higher frequency than placebo
² OMVOH 300 mg as an IV infusion at Weeks 0, 4, and 8
³ Upper respiratory tract infections includes related terms (e.g., COVID-19, nasopharyngitis, pharyngitis, rhinitis, sinusitis, and upper respiratory tract infection)
Abbreviations: IV, intravenous; N, number of subjects in treatment group; Q4W, once every four weeks

Table 7. Adverse Reactions1 by Week 40, UC-2

Source: OMVOH Prescribing Information
¹ Reported in at least 2% of subjects and at a higher frequency than placebo
² OMVOH 200 mg as a SC injection at Week 12 and every four weeks thereafter for up to an additional 40 weeks
³ Upper respiratory tract infections includes related terms (e.g., COVID-19, nasopharyngitis, pharyngitis, rhinitis, sinusitis, and upper respiratory tract infection)
⁴ Injection site reactions includes related terms (e.g., erythema, hypersensitivity, pain, reaction, and urticaria at the injection site)
⁵ Rash is composed of several similar terms
⁶ Herpes viral infection includes related terms (e.g., herpes zoster, herpes simplex, and oral herpes)
Abbreviations: N, number of subjects in treatment group; Q4W, once every four weeks; SC, subcutaneous

Were there any differences in side effects of the clinical trials among sex, race, and age groups?

Subgroup analyses were conducted to assess the potential for differences in the side effects for various demographics. Overall, the reported side effects of OMVOH compared to placebo appeared consistent between demographic subgroups of sex, and in White and Asian patients. There was an insufficient number of patients older than 65 years of age, races other than White and Asian, and Hispanic or Latino ethnicity to determine any differences in side effects in adults older than 65, races other than White and Asian, and patients of Hispanic or Latino ethnicity.

Table 8. Adverse Events by Week 12 by Sex, Age, Race, and Ethnicity, UC-1

Source: Adapted from FDA Review
¹ OMVOH 300 mg as an IV infusion at Weeks 0, 4, and 8
Abbreviations: CI, confidence interval; IV, intravenous; N, number of subjects; NA, not applicable; Q4W, once every four weeks

Table 9. Adverse Events by Week 40 by Sex, Age, Race, and Ethnicity, UC-2

Source: Adapted from FDA Review
¹ OMVOH 200 mg as a SC injection at Week 12 and every four weeks thereafter for 40 weeks.
Abbreviations: CI, confidence interval; N, number of subjects; NA, not applicable; Q4W, once every four weeks; SC, subcutaneous