A Study to Evaluate RIST4721 in Hidradenitis Suppurativa (HS)

Aristea Therapeutics

Status and phase: Terminated; Phase 2

Conditions: Hidradenitis Suppurativa

Treatments: Drug: RIST4721; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05348681

RIST4721-221

Details and patient eligibility

About

A Randomized, Double-blinded, Placebo-controlled, Phase 2a Study to Evaluate the Efficacy and Safety of RIST4721 in Subjects with Hidradenitis Suppurativa

Enrollment: 25 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of HS for at least 1 year prior to screening
• HS lesions must be present in at least 2 distinct anatomic areas
• A total AN count (sum of abscesses and inflammatory nodules) > 6 across all anatomical sites at both the screening and baseline visits
• Willing to use contraception for the duration of the study

Exclusion criteria

• Presence of other skin conditions which may interfere with study assessments
• Presence of active, chronic or latent bacterial, viral, fungal mycobacterial infection (including latent TB) or history of infection within 4 weeks of screening
• Body Mass Index (BMI) >48kg/m2
• Breastfeeding or pregnant

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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25 participants in 2 patient groups, including a placebo group

RIST4721 400 mg

Experimental group

Description:

RIST4721 400 mg: 4 active (100 mg) tablets once daily for 12 weeks

Treatment:

Drug: RIST4721

Placebo

Placebo Comparator group

Description:

Placebo: 4 placebo tablets once daily for 12 weeks

Treatment:

Drug: Placebo