CURRENT DERMATOLOGY CLINICAL TRIALS

Galderma 202685 (Olympia 1):
A randomized, double-blind, placebo-controlled study for patients aged ≥18 with Prurigo Nodularis (PN) to assess the efficacy and safety of Nemolizumab after a 32-week treatment period.

• Treatment requires visits to Topeka office every 4 weeks for 32-week treatment period

• Optional open-label rollover extension study after this study is over—52 week treatment period with visits to Topeka every 4 weeks plus a safety follow-up visit 8 weeks after the last dose

Inclusion Criteria:
• > 20 PN lesions at the time of screening and randomization on upper limbs, trunk, and/or lower limbs (bilateral distribution)

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Eli Lilly J2T-MC-KGAK (ADopt):
A 16-week study for patients aged ≥ 18 with Atopic Dermatitis.

• Treatment requires visits to Topeka office every 2 weeks for 16-week treatment period

• Optional rollover extension trial after this study is over—52 week treatment period with visits to Topeka office every 2-12 weeks plus a safety follow-up visit 12 weeks after the last dose
Exclusion Criteria:
• Received MCV (within 4 years) + Tdap(within 5 years)

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UCB PS0007 (CIMcare):
A double-blind study for pediatric patients aged 6-17 with Plaque Psoriasis affecting > 10% of body surface area.

Study drug is Certolizumab Pegol (CZP).
• TNF inhibitor
• Every 2 week SQ injections
Inclusion Criteria:
• PGA ≥3, PASI ≥12 or PASI ≥10 and <12 with clinically relevant facial/scalp, genital, palm and sole, or axillary involvement

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Cohort A: patients aged 12-17 will receive double-blinded CZP vs. placebo (3:1 CZP : placebo) for the first 12 weeks of treatment; will receive open-label CZP starting with week 16 dose.
• 16-week double-blind treatment period,36-week active treatment period, 104-week open-label extension period—156 weeks total treatment, then 8-week safety follow-up period

Cohort B: patients aged 6-11 will receive open-label Certolizumab Pegol (CZP).
• This cohort will start only when the week 12PK analysis is completed in the cohort of older participants and if the drug’s safety profile is shown to be positive
• 52-week open-label active treatment period plus 104-week open-label extension period—156 weeks total treatment, then 8-week safety follow-up period