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The goal of this clinical trial is to learn if CIT-013 works to treat Hidradenitis Suppurativa in adults. It will also learn about the safety of CIT-013. The main questions it aims to answer are:
Does CIT-013 lower the disease activity of HS patients? What medical problems do participants have when receiving CIT-013? Researchers will compare CIT-013 to a placebo (a look-alike substance that contains no drug) to see if CIT-013 works to treat the symptoms of HS.
Participants will:
Take receive 50 or 100 mg CIT-013 or placebo every other week for 12 weeks Visit the clinic once every 2 weeks for checkups and tests Keep monitor their symptoms during this period
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CIT-013 high dose | Experimental | 6 SC injections with CIT-013 high dose |
|
| CIT-013 medium dose | Experimental | 6 SC injections with CIT-013 medium dose |
|
| Placebo | Placebo Comparator | 6 SC injections with placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CIT-013 high dose | Drug | subcutaneous injection |
| |
| CIT-013 medium dose |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants with HiSCR75 on CIT 013 versus placebo | week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of TEAEs as assessed by CTCAE | week 12 | |
| Maximum Plasma Concentration of CIT-013 before doses | 4, 6, 10 and 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
- Participants for whom an approved therapy with demonstrated clinical benefit is indicated, available and expected to be tolerated, OR choose to proceed with standard of care treatment options over the IP (after being appropriately informed of the treatment options, risks, and benefits).
Any current and/or recurrent clinically significant skin condition in the treatment area other than HS,
Prior treatment with a recombinant therapeutic protein during the 6 weeks before baseline
Prior treatment with any of the following medications before baseline:
History of malignancy with exception of non-melanoma skin cancer that has been excised and cured,
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Leonie M Middelink | Contact | +31613328444 | lmiddelink@citryll.com |
| Name | Affiliation | Role |
|---|---|---|
| Maarten Kraan | Citryll BV | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CA-01 | Recruiting | Barrie | Canada |
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| Drug |
subcutaneous injection |
|
| Placebo | Drug | subcutaneous injection |
|
| CA-05 | Recruiting | Calgary | Canada |
|
| CA-02 | Recruiting | London | Canada |
|
| CA-04 | Recruiting | Newmarket | Canada |
|
| CA-03 | Recruiting | Winnipeg | Canada |
|
| DE-06 | Recruiting | Bad Bentheim | Germany |
|
| DE-01 | Recruiting | Bochum | Germany |
|
| DE-04 | Recruiting | Dresden | Germany |
|
| DE-02 | Recruiting | Frankfurt | Germany |
|
| DE-08 | Recruiting | Kiel | Germany |
|
| DE-03 | Recruiting | Oldenburg | Germany |
|
| Erasmus UMC | Recruiting | Rotterdam | Netherlands |
|
| PL-06 | Recruiting | Bialystok | Poland |
|
| PL-08 | Recruiting | Gdansk | Poland |
|
| PL-03 | Recruiting | Katowice | Poland |
|
| PL-02 | Not yet recruiting | Lodz | Poland |
|
| PL-10 | Recruiting | Lodz | Poland |
|
| PL-09 | Recruiting | Poznan | Poland |
|
| PL-01 | Recruiting | Rzeszów | Poland |
|
| PL-05 | Recruiting | Wroclaw | Poland |
|
| ES-05 | Not yet recruiting | Barcelona | Spain |
|
| ES-04 | Not yet recruiting | Madrid | Spain |
|
| ES-02 | Not yet recruiting | Santiago de Compostela | Spain |
|
| ES-03 | Not yet recruiting | Seville | Spain |
|
| ES-01 | Recruiting | Valencia | Spain |
|
| GB-02 | Recruiting | Cardiff | United Kingdom |
|
| GB-05 | Recruiting | Chester | United Kingdom |
|
| GB-04 | Recruiting | London | United Kingdom |
|
| ID | Term |
|---|---|
| D017497 | Hidradenitis Suppurativa |
| ID | Term |
|---|---|
| D017192 | Skin Diseases, Bacterial |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D012874 | Skin Diseases, Infectious |
| D013492 | Suppuration |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D016575 | Hidradenitis |
| D013543 | Sweat Gland Diseases |
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