WithdrawnPhase 2

Study of the Efficacy and Safety of RPH-104 in Adult Subjects With Schnitzler Syndrome

Stopped: due to the decision of company Top management

United States0Started 2023-05

Plain-language summary

The primary goal of the study is to assess the efficacy and safety of RPH-104 in subjects with Schnitzler Syndrome using Schnitzler Disease Activity Score (SDAS), which includes the Physician's Global Assessment (PGA) and the local laboratory C-reactive protein (CRP) result

Who can participate

Age range18 Years – 100 Years

SexALL

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Inclusion criteria

✓. Complete abstinence: if it corresponds to the preferred and conventional lifestyle of the female subject. Periodic abstinence (eg, calendar, ovulation, symptothermal, postovulation method) and interrupted coitus are not considered acceptable contraceptive methods.
✓. Sterilization: surgical bilateral ovariectomy (with/without hysterectomy) or tubal ligation at least 6 weeks prior to the study therapy initiation. In case of ovariectomy only the female reproductive status should be verified by further hormonal test.
✓. Sterilization of male partner with documented absence of sperm in ejaculate post vasectomy for at least 6 months (vasectomized male partner should be the only partner of the participating female subject).
✓. Combination of 2 of the following methods (i + ii, i + iii, or ii + iii):

Exclusion criteria

✕. History of active tuberculosis (TB), evidence of active or latent M. tuberculosis infection as defined by local guidelines/local medical practice at Screening.
✕. Positive QuantiFERON Gold Plus (TB) test at Screening.
✕. Chest X ray findings confirming pulmonary TB at Screening.

What they're measuring

Proportion of subjects with complete response (Schnitzler Disease Activity Score (SDAS = 0)) to therapy on Day 14 in the RPH-104 group as compared to the placebo group

Timeframe: Day 14

Trial details

NCT IDNCT04213274

SponsorR-Pharm Overseas, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-08

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