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Tests treatment safety and results for Hidradenitis Suppurativa (HS)
Official title Efficacy and Safety of SCT650C in Participants With Moderate to Severe Hidradenitis Suppurativa
ClinicalTrials.gov ID: NCT07244510
What this study is testing
What is SCT650C?
SCT650C is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for hidradenitis suppurativa (hs).
Also referred to as Recombinant anti-IL-17A antibody.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this study is to assess efficacy, safety, pharmacokinetics and immunogenicity of subcutaneous SCT650C in patients with Moderate to Severe Hidradenitis Suppurativa
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- The participants must be at least 18 years of age at the time of signing the ICF.
- Study participants must have a diagnosis of HS based on clinical history and physical examination for at least 6 months prior to the baseline visit...
- Study participants must have HS lesions in at least 2 distinct anatomic areas (eg, left and right axilla), 1 of which must be at least Hurley Stage...
- Study participants must have moderate to severe HS defined as a total of ≥ 5 inflammatory lesions (ie, number of abscesses plus number of...
- Study participants must have had a history of inadequate response, intolerance or contraindication to a course of systemic antibiotics for treatment...
You likely can't join if
- Study participant has any medical or psychiatric condition could jeopardize or would compromise the study participant's ability to participate in...
- Study participant has a draining fistula count of \> 20 at the Baseline Visit.
- Study participant has any other active skin disease or condition (eg, bacterial cellulitis, candida intertrigo, extensive condyloma) that may, in the...
- Study participant has a diagnosis of sarcoidosis, systemic lupus erythematosus, or active inflammatory bowel disease (IBD).
- Study participant has a primary immunosuppressive condition, including taking immunosuppressive therapy following an organ transplant or has had a...
- Female study participant who is breastfeeding, pregnant, or plans to become pregnant during the study or within 40 weeks following the final dose of...
See the full eligibility criteria
Who can join
- The participants must be at least 18 years of age at the time of signing the ICF.
- Study participants must have a diagnosis of HS based on clinical history and physical examination for at least 6 months prior to the baseline visit; diagnosis must be verifiable through medical notes and documentation.
- Study participants must have HS lesions in at least 2 distinct anatomic areas (eg, left and right axilla), 1 of which must be at least Hurley Stage II or Hurley Stage III at both the Screening and Baseline visits.
- Study participants must have moderate to severe HS defined as a total of ≥ 5 inflammatory lesions (ie, number of abscesses plus number of inflammatory nodules) at both the Screening and Baseline visits.
- Study participants must have had a history of inadequate response, intolerance or contraindication to a course of systemic antibiotics for treatment of HS at the Screening Visit as assessed by the investigator.
- Participants agree to daily use of topical antiseptics on the areas affected by HS lesions while on study treatment. Allowable antiseptic washes are limited to one of the following: chlorhexidine gluconate, benzoyl...
- Participants entering the study while undergoing concomitant treatment with systemic antibiotics (as specified in the protocol) must be on a stable dose. A stable dose is defined as a dosage or regimen that has remained...
- Female participants must be not of childbearing potential or permanently sterilized (e.g., tubal occlusion, hysterectomy, bilateral salpingectomy) or, if of childbearing potential (and engaged in sexual activity that...
- progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable);
- combined (estrogen and progestogen) hormonal contraception associated with inhibition of ovulation (oral, intravaginal or transdermal);
- intrauterine device (IUD);
- intrauterine hormone-releasing system (IUS);
- bilateral tubal occlusion;
- vasectomized partner (where postvasectomy testing had demonstrated sperm clearance);
- Sexual abstinence if it is in accordance with a participant's preferred and common lifestyle. Note: Participants who use abstinence as a form of birth control must agree to abstain from heterosexual intercourse until 40...
- An Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved written Informed Consent form is signed and dated by the participant.
What rules you out
- Study participant has any medical or psychiatric condition could jeopardize or would compromise the study participant's ability to participate in this study as determined by the investigator based on protocol-required...
- Study participant has a draining fistula count of \> 20 at the Baseline Visit.
- Study participant has any other active skin disease or condition (eg, bacterial cellulitis, candida intertrigo, extensive condyloma) that may, in the opinion of the investigator, interfere with the assessment of HS.
- Study participant has a diagnosis of sarcoidosis, systemic lupus erythematosus, or active inflammatory bowel disease (IBD).
- Study participant has a primary immunosuppressive condition, including taking immunosuppressive therapy following an organ transplant or has had a splenectomy.
- Female study participant who is breastfeeding, pregnant, or plans to become pregnant during the study or within 40 weeks following the final dose of IMP.
- Study participant has an active infection or history of infection(s) as follows:
- Any infection requiring systemic treatment within 28 days prior to Baseline;
- A history of opportunistic, recurrent, or chronic infections that, in the opinion of the investigator, might cause this study to be detrimental to the study participant. Opportunistic infections are infections caused by...
- Study participant has any of the following (for more information, refer to Section 9.2):
- Known active tuberculosis (TB) disease;
- History of active TB involving any organ system unless adequately treated according to World Health Organization/ Centers for Disease Control and Prevention therapeutic guidance and proven to be fully recovered upon...
- Latent TB infection (LTBI).
- High risk of acquiring TB infection.
- Current or history of NTMB infection.
- Study participant has an acute or chronic hepatitis B virus, hepatitis C virus (HCV), or human immunodeficiency virus (HIV) infection or treponema pallidum antibody (TPPA) positive. Study participants who have evidence...
- A positive test for hepatitis B virus is defined as: 1) positive for hepatitis B surface antigen (HBsAg+), or 2) HBsAg is negative, HBcAb is positive and HBV-DNA test results ≥ the upper limit of the reference value of...
- A positive test for HCV is defined as: 1) positive for hepatitis C antibody (HCVAb+); and 2) positive via a confirmatory test for HCV (for example, HCV polymerase chain reaction).
- Study participants with concurrent malignancy are excluded. Study participants with a history of malignancy within the past 5 years prior to the Screening Visit are excluded, EXCEPT if the malignancy was a cutaneous...
- Study participant has a history of a lymphoproliferative disorder including lymphoma or current signs and symptoms suggestive of lymphoproliferative disease.
- Study participant has had major surgery within the 3 months prior to the Baseline Visit, or has planned major surgery after entering the study.
- Study participant has any systemic disease (ie, cardiovascular, neurological, renal, liver, metabolic, gastrointestinal, hematological, immunological, etc.) considered by the investigator to be uncontrolled, unstable...
- Study participant has had a myocardial infarction or stroke within the 6 months prior to the Screening Visit.
- Study participant has a history of chronic alcohol or drug abuse within 6 months prior to Screening as evaluated by the investigator based on medical history and interview.
- Study participant has a history of depression and/or suicidal thoughts or behaviors are considered not suitable for participation in the clinical study by the investigator.
- The participant has a known hypersensitivity to any excipients of SCT650C.
- Study participants with prior exposure to biologic agents that block IL-12/23 (e.g., ustekinumab), IL-23 (e.g., risankizumab, guselkumab), or IL-17 (e.g., secukinumab) within 3 months prior to the Baseline visit.
- Study participants with prior exposure to anti-TNF therapy (e.g., adalimumab, infliximab) for any indication within 2 months prior to the Baseline visit.
- Study participants who have had prior exposure to other immunomodulatory biologic therapies, including anti-IL-1 (e.g., anakinra, canakinumab), within 3 months or 5 half-lives, whichever is longer, prior to the Baseline...
- Previous treatment with any cell-depleting therapies, including but not limited to anti-CD20 (e.g., rituximab) within 12 months prior to the Baseline visit or until B cell count returns to normal level.
- Use of traditional medicines or herbal remedies within 28 days prior to the Baseline visit.
- Study participants have received non-allowable topical therapies (including topical antibiotics) for the treatment of HS within 14 days prior to the Baseline visit.
- Study participants have received systemic non-biologic therapies (e.g. methotrexate (MTX), cyclosporine A, retinoids, apremilast, phototherapy) for the treatment of HS within 28 days prior to the Baseline visit.
- For HS and non-HS related pain, participants have received oral concomitant analgesics (including opioids) within 14 days prior to the Baseline visit. Exception: Participants may continue on non-opioid analgesics...
- Study participants have received any live vaccine within 8 weeks prior to the first dose of study drug (Baseline), or expect the need for live vaccination during study participation including within 40 weeks after the...
- Study participants have been treated with any other investigational drug within 30 days or 5 half-lives of the drug (whichever is longer) prior to the first dose of study drug or is currently enrolled in another...
- Study participant has laboratory abnormalities at Screening, including any of the following:
- \>2× the upper limit of normal (ULN) of any of the following: alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP)
- Total Bilirubin \>2×ULN
- White blood cell count \<3.00×103/μL
- Absolute neutrophil count \<1.5×103/μL
- Lymphocyte count \<500 cells/μL
- Hemoglobin \<8.5g/dL
- Creatinine \>1.5 ×ULN Note: Tests that result in ALT, AST, ALP or total bilirubin up to 25% above the exclusion limit may be repeated for confirmation during the Screening Period. Upon retesting, participants whose ALT...
- Study participant has an estimated glomerular filtration rate (GFR) as measured by Chronic Kidney Disease Epidemiology Collaboration \<60mL/min/1.73m2 [GFR (male)=(140-age)ⅹWeight/serum creatinineⅹ1.23; GFR...
- Study participant has any other laboratory abnormality that, in the investigator's opinion, will prevent the study participant from completing the study or will interfere with the interpretation of the study results.
- The participant is a SinoCellTech (SCT) employee or is an employee of third-party organizations involved in the study.
- The participant and/or his or her immediate family member is an employee, volunteer, or other worker at the investigative site, either affiliated or not affiliated with this study. Immediate family is defined as a...
The study team makes the final eligibility decision.
Where it's taking place
- Samsun, Turkey, Turkey (Türkiye)
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, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Samsun, Turkey, Turkey (Türkiye). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.