A Study of JNJ-78934804 in Participants With Moderately to Severely Active Ulcerative Colitis
This research study is looking at a new medicine called JNJ-78934804 for adults who have a bowel condition called ulcerative colitis. Specifically, it's for people whose condition is moderate to severe. Ulcerative colitis causes inflammation and sores in the large bowel. The main goal of this study is to find out how effective and safe this new medicine is, compared to another established medicine called guselkumab, over a period of 48 weeks (nearly a year). This is a 'Phase 3' study, which means it's one of the final steps before a new medicine might be approved for wider use. By taking part, you could help doctors understand more about treating this condition.
Em resumo
Sobre o que é este estudo?
Ulcerative colitis is a long-term condition that affects your large bowel (colon). It causes the lining of your bowel to become inflamed and develop small sores, leading to symptoms like tummy pain, diarrhoea, and needing to go to the toilet urgently. For some people, these symptoms can be quite severe and significantly impact their daily life. Doctors are always looking for better ways to manage this condition.
This study is testing a new medicine called JNJ-78934804. It's a 'Phase 3' study, which means it's one of the last stages of testing before a new medicine can be considered for approval. The main aim is to see how well this new medicine works to help people with moderate to severe ulcerative colitis, and to check if it's safe to use. We'll be comparing it to an existing medicine called guselkumab, which is already used to treat some conditions.
The study will last for 48 weeks, which is nearly a year. During this time, participants will receive either the new medicine or the existing one, and doctors will carefully monitor their symptoms and overall health. The information gathered from this study will help us understand if JNJ-78934804 could be a new and effective treatment option for people living with ulcerative colitis.
Pontos principais
- This study is testing a new medicine (JNJ-78934804) for moderate to severe ulcerative colitis.
- It aims to see how effective and safe the new medicine is compared to an existing treatment (guselkumab).
- The study lasts for 48 weeks and involves regular check-ups.
- It's for adults whose ulcerative colitis hasn't responded well to previous treatments.
- Your participation could help advance treatments for ulcerative colitis.
Quem pode ser elegível?
To join this study, you must be an adult aged 18 or over. You need to have been diagnosed with ulcerative colitis at least 12 weeks ago, and doctors must have confirmed this with an endoscopy (a camera test) and a tissue sample (biopsy).
Your ulcerative colitis needs to be active and fall into the 'moderate to severe' category at the start of the study. This means your symptoms are significantly affecting you. Also, previous treatments you've tried for your ulcerative colitis haven't worked well enough, or you couldn't tolerate them.
There are certain reasons why you wouldn't be able to join. For example, if your ulcerative colitis only affects the very last part of your bowel (rectum) or if doctors suspect you might have a different bowel condition like Crohn's disease. You also can't join if you've had certain serious infections, or if you've had a bad reaction to guselkumab or a similar medicine called golimumab before. Women who are pregnant, breastfeeding, or planning to become pregnant, or men planning to father a child within 6 months of the study, cannot participate.
Este estudo pode ser adequado para você?
Responda a estas perguntas rápidas para ver se você pode ser elegível. Este é apenas um guia — a decisão final é da equipe de pesquisa.
- Você tem 18 anos ou mais?
- Have you been diagnosed with ulcerative colitis for at least 12 weeks?
- Is your ulcerative colitis currently active and considered moderate to severe?
- Have your previous treatments for ulcerative colitis not worked well enough, or did you have problems with them?
- Are you NOT pregnant, breastfeeding, or planning a pregnancy (or planning to father a child) during the study?
- Have you NOT had a bad reaction to guselkumab or golimumab before?
O que envolve a participação?
If you decide to take part in this study, you would receive either the new medicine, JNJ-78934804, or the existing medicine, guselkumab. Both medicines would be given in a way specified by the study doctors.
Throughout the study, you would have regular appointments at the clinic. These visits will involve various checks, such as physical exams, blood tests, and possibly endoscopies (camera tests to look inside your bowel). These assessments help the doctors understand how the medicine is working and to monitor your health and safety.
The study is planned to last for 48 weeks (nearly a year). After you finish taking the study medicine, there might be some follow-up visits to ensure your well-being. The study team will explain the full schedule of visits and what each involves if you are interested in taking part.
Riscos e benefícios potenciais
Locations (279)
- Clinnova ResearchCódigo postal verificadoAnaheim, United States· Recrutamento
- Gastro SB ClinicCódigo postal verificadoChula Vista, Estados Unidos· Recrutamento
- United Medical DoctorsCódigo postal verificadoLos Alamitos, Estados Unidos· Recrutamento
- Grupo de Pesquisa de Associados Médicos, Inc.Código postal verificadoSan Diego, Estados Unidos· Recrutamento
- Peak Gastroenterology AssociatesCódigo postal verificadoColorado Springs, Estados Unidos· Recrutamento
- Florida Research Center Inc.Código postal verificadoLakewood Rch, United States· Recrutamento
- Sanchez Clinical Research, IncCódigo postal verificadoMiami, Estados Unidos· Recrutamento
- GCP Clinical ResearchCódigo postal verificadoTampa, Estados Unidos· Recrutamento
- Atlanta Gastroenterology SpecialistsCódigo postal verificadoSuwanee, United States· Recrutamento
- Tri-State Gastroenterology AssocCódigo postal verificadoCrestview Hills, United States· Recrutamento
- Gastroenterology Clinic of AcadianaCódigo postal verificadoLafayette, United States· Recrutamento
- GIA MetairieCódigo postal verificadoMetairie, Estados Unidos· Recrutamento
Perguntas frequentes
O que é colite ulcerativa?
It's a long-term condition where the lining of your large bowel (colon) becomes inflamed and develops sores, causing symptoms like tummy pain and urgent diarrhoea.
What is the new medicine being tested?
It's called JNJ-78934804. This study is looking at how well it works and if it's safe for people with moderate to severe ulcerative colitis.
Quanto tempo dura o estudo?
The main part of the study where you receive treatment will last for 48 weeks, which is almost a year.
Will I know if I'm getting the new medicine or the existing one?
In most studies like this, participants don't know which medicine they are receiving until after the study has finished. This helps to make sure the results are fair and unbiased.
Posso parar de participar se mudar de ideia?
Yes, absolutely. You can withdraw from the study at any time, for any reason, without it affecting your medical care.
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