Effect of Anti-Psoriatic Biologics on Risk of Anogenital Warts (CONDYPSO)

Sponsor
Jonathan Krygier
Study ID
NCT07234838
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Study Details

This study aims to assess the impact of anti-TNF-α, anti-IL-17, and anti-IL-23 biologic therapies on the risk of development or recurrence of anogenital warts (AGW) in patients with moderate to severe psoriasis. By modulating systemic and mucosal immunity, these treatments may alter host defenses against human papillomavirus (HPV) infections, which are responsible for AGW. In particular, inhibition of Th1 pathways (by anti-TNF-α) and Th17 pathways (by anti-IL-17 and anti-IL-23), both central to the antiviral response, may reduce local production of pro-inflammatory cytokines (such as IFN-γ, IL-17, and IL-22), decrease the activity of CD8+ cytotoxic T lymphocytes, and impair dendritic cell function, thereby compromising viral clearance at the genital mucosa. AGW are a frequent and recurrent manifestation of HPV infection, and their incidence may be influenced by these immunomodulatory treatments. The retrospective component will review cases already documented in medical records and analyze, to the extent permitted by available data, the same risk factors as in the prospective component, including history of sexually transmitted infections (STIs), risk behaviors, treatments used (systemic or topical), and time to onset or recurrence of AGW. This analysis will be conducted as a retrospective case-control study, matching each patient who developed AGW with one or more controls receiving biologics who did not develop AGW, in order to identify factors associated with their occurrence. The prospective follow-up will assess, over 24 months, risk factors for occurrence or recurrence of AGW in patients with moderate to severe psoriasis, according to the treatment received: no treatment, topical treatment, systemic non-immunomodulatory treatment, or immunomodulatory treatment, including biologics. Acceptability of HPV vaccination will also be evaluated, at enrollment, in a subset of prospectively included adult patients without a known history or current clinical lesion of condyloma, HSIL, or HPV-induced carcinoma.

Key Dates

First listed
Nov 18, 2025
Start date
Feb 1, 2026
Status verified
Mar 2026
Primary completion
Aug 1, 2028
Completion
Aug 1, 2028

Study Design

Enrollment
600 participants (estimated)

Arms

  • Arm: Biologic therapies (Anti-TNF, Anti-IL-17, Anti-IL-23, including ustekinumab)
    Psoriasis patients receiving biologic therapies. Observational follow-up of anogenital HPV-related outcomes (warts, recurrences, cytology, vaccination acceptability).
  • Arm: Other immunomodulators (methotrexate, cyclosporine, deucravacitinib, dimethyl fumarate)
    Psoriasis patients receiving systemic immunomodulators other than biologics. Observational follow-up of anogenital HPV-related outcomes.
  • Arm: Other systemic non-immunomodulators (apremilast, acitretin)
    Psoriasis patients receiving systemic therapies not primarily immunomodulatory. Observational follow-up of anogenital HPV-related outcomes.
  • Arm: Topical therapy only (topical corticosteroids, calcineurin inhibitors, phototherapy)
    Psoriasis patients managed with topical therapy and/or phototherapy only. Observational follow-up of anogenital HPV-related outcomes.
  • Arm: Untreated psoriasis patients
    Psoriasis patients currently not receiving any systemic or topical therapy. Observational follow-up of anogenital HPV-related outcomes.

Primary Outcome Measure

Incidence of anogenital warts [ Time Frame: From enrollment until the end of the 2-year follow-up ]

Central Contacts

Find similar trials

Nationwide
Psoriasis trialsDermatology trialsRheumatology trialsAutoimmune disease trials

Related Studies