Authorised Therapeutic confirmatory (Phase III) Prurigo Nodularis

Selective Treatment of Oral Povorcitinib in Prurigo Nodularis Study 1 (STOP-PN1)

EU CTIS ID: 2024-511879-16-00

What this study is testing

To evaluate the effect of povorcitinib on itch and skin lesions in participants with PN

Therapeutic confirmatory (Phase III)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

1. Ability to comprehend and willingness to sign a written ICF for the study.
2. 18 to 75 years of age. Note: For South Korea, 19 years of age or older.
3. Clinical diagnosis of PN for at least 3 months before screening.
4. Pruritus, defined as an average Itch NRS score ≥ 7 during the 7 days prior to Day 1.
5. ≥ 20 pruriginous lesions in total on ≥ 2 different body regions (both legs, and/or both arms, and/or trunk) at screening and Day 1.
6. IGA-CPG-S score ≥ 3 at screening and Day 1.

You likely can't join if

1. Chronic pruritus due to a condition other than PN.
18. Known hypersensitivity or severe reaction to povorcitinib or excipients of povorcitinib (refer to the IB) and/or other products in the same class.
19. Any condition, laboratory result, or result of screening assessments that would, in the investigator's and sponsor's (or designee's) judgment, interfere with full participation in the study, including administration of study drug and attending required study visits, pose a significant risk to the participant, or interfere with interpretation of study data.
2. Neuropathic and psychogenic pruritus.
20. The following participants are excluded in France: vulnerable populations according to article L.1121-6 of the French Public Health Code and adults under legal protection or who are unable to express their consent per article L.1121-8 of the French Public Health Code, not affiliated to a social security per article L.1121-8-1 of the French Public Health Code.
3. Diagnosis of PN secondary to medications.

See the full eligibility criteria

Who can join

1. Ability to comprehend and willingness to sign a written ICF for the study.
2. 18 to 75 years of age. Note: For South Korea, 19 years of age or older.
3. Clinical diagnosis of PN for at least 3 months before screening.
4. Pruritus, defined as an average Itch NRS score ≥ 7 during the 7 days prior to Day 1.
5. ≥ 20 pruriginous lesions in total on ≥ 2 different body regions (both legs, and/or both arms, and/or trunk) at screening and Day 1.
6. IGA-CPG-S score ≥ 3 at screening and Day 1.
7. Documented history of treatment failure, demonstrated intolerance, or contraindication to a previous PN treatment (eg, TCS or TCI) with the exception of treatment failure with prior topical or systemic JAK or TYK2 inhibitors (see Exclusion Criterion 10).
8. Willingness to avoid pregnancy or fathering children based on the criteria detailed in section 5.1. of the protocol (under inclusion criteria 8).
9. Willing and able to comply with the study protocol and procedures.

What rules you out

1. Chronic pruritus due to a condition other than PN.
18. Known hypersensitivity or severe reaction to povorcitinib or excipients of povorcitinib (refer to the IB) and/or other products in the same class.
19. Any condition, laboratory result, or result of screening assessments that would, in the investigator's and sponsor's (or designee's) judgment, interfere with full participation in the study, including administration of study drug and attending required study visits, pose a significant risk to the participant, or interfere with interpretation of study data.
2. Neuropathic and psychogenic pruritus.
20. The following participants are excluded in France: vulnerable populations according to article L.1121-6 of the French Public Health Code and adults under legal protection or who are unable to express their consent per article L.1121-8 of the French Public Health Code, not affiliated to a social security per article L.1121-8-1 of the French Public Health Code.
3. Diagnosis of PN secondary to medications.
4. Active AD lesions within 3 months of screening.
5. Pregnant (or are considering pregnancy) or breastfeeding.
6. Concurrent conditions or history of other diseases detailed in section 5.2. of the protocol (under exclusion criteria 6).
7. A screening 12-lead ECG that demonstrates clinically significant abnormalities requiring treatment (eg, acute myocardial infarction, serious tachyarrhythmias or bradyarrhythmias) or that is indicative of serious underlying heart disease (eg, cardiomyopathy, major congenital heart disease, low voltage in all leads, Wolff Parkinson-White syndrome) or criteria associated with QT/QTcF abnormalities.
8. Significant trauma or major surgery (per investigator's assessment) within 30 days prior to screening.
10. History of treatment failure for PN or any other inflammatory condition.
9. Planned or expected major surgery during the initial 24 weeks of treatment with study drug (ie, during the PC period of the study).
13. Receipt of medical treatment or investigational drugs within intervals specified in section 5.2 of the protocol (under exclusion criteria 13)
11. History of clinically significant (per investigator's judgment) drug or alcohol abuse within 6 months prior to screening.
12. Initiation or changing the dose of any of the treatments listed in section 5.2. of the protocol (under exclusion criteria 12) within 3 months of Day 1 or expected dose change of any of the following treatments during the initial 24 weeks of treatment with study drug (ie, during the PC period).
14. Concurrent enrollment in another clinical study.
15. At the screening visit, any of the laboratory abnormalities defined in Table 6 of the protocol.
Evidence of infection with Mycobacterium tuberculosis (ie, TB) as defined in Section 8.3.5.2.
16. Active HIV or acquired immunodeficiency syndrome. Active HIV is defined as a confirmed positive anti-HIV antibody test (see Section 8.3.5.3).
17. Evidence of HBV or HCV infection or risk of reactivation (see Section 8.3.5.4).

The study team makes the final eligibility decision.

Where it's taking place

Argentina
United States
Korea, Republic of
Canada
Switzerland

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Argentina; United States; Korea, Republic of; Canada; Switzerland. Enter your location above to see the nearest site and check your eligibility.

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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.