A Study of Long-acting Antibodies SPY001-001 and SPY002 Alone and Combined for Adults with Moderate to Severe Ulcerative Colitis

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What is this study about?

This study involves people with ulcerative colitis that is moderately to severely active. Ulcerative colitis is a long-term condition where the lining of the large intestine becomes inflamed and develops sores. The study will test several experimental medications that are long-acting antibodies, which are proteins designed to work in the body for an extended period. The medications being tested include SPY001-001 and SPY002, along with additional experimental treatments called SPYPBO-101 and SPYPBO-102. These medications will be given either alone or in combination with each other. Some medications will be given through a needle into a vein, which is called intravenous administration, while others will be given as an injection under the skin, which is called subcutaneous administration. The purpose of this study is to see how well these treatments work and how safe they are for people with this condition.

The study is divided into two parts, called Part A and Part B. In Part A, researchers will look at changes in the tissue of the intestine after 12 weeks of treatment to see if the disease activity has decreased. In Part B, researchers will check if the treatment can help people achieve clinical remission, which means having no or minimal symptoms of the disease, after 12 weeks of treatment. Participants will receive their assigned treatment and have regular check-ups where doctors will examine their condition. This includes procedures where a flexible tube with a camera is used to look inside the intestine, called endoscopy, and taking small tissue samples to examine under a microscope. Some participants may also be taking corticosteroids, which are medications that reduce inflammation, and they may need to continue or gradually reduce these medications during the study.

Throughout the study, doctors will monitor how the medications are working by checking various signs of the disease. They will measure things like changes in disease scores, improvement in the appearance of the intestine lining, and reduction in symptoms. The study will also track the levels of the study medications in the blood and check if the body develops any immune response to these treatments. Part A will last for 12 weeks, while Part B will continue for up to 48 weeks. The study is expected to start enrolling participants in late 2025 and is planned to be completed by early 2028.

1 Screening and confirmation of eligibility

Your diagnosis of ulcerative colitis (inflammation of the large intestine causing ulcers) will be confirmed through endoscopy (a procedure using a camera to look inside the intestine) and tissue analysis if this has not been done previously.

Your disease must have been present for at least 3 months before starting the study.

The inflammation must extend at least 15 centimeters from the anal opening, confirmed by the screening endoscopy.

Your disease activity will be assessed using a scoring system that evaluates symptoms such as bowel movements, rectal bleeding, and the appearance of the intestinal lining during endoscopy. Your score must be between 5 and 9 points, with visible bleeding and significant inflammation.

If you are taking corticosteroids (medications that reduce inflammation) by mouth, the dose must be stable for at least 2 weeks before starting the study. The maximum allowed dose is 20 milligrams per day of prednisone or an equivalent amount of similar medications.

2 Assignment to Part A or Part B

You will be assigned to either Part A or Part B of the study. Both parts last 12 weeks initially, but Part B may continue up to 48 weeks.

The assignment will determine the specific treatment approach and assessment methods used during the study.

3 Treatment period from Day 1 to Week 12

You will receive one or more of the study medications. The medications used in this study are SPY001-001 and SPY002, which are long-acting antibodies designed to reduce inflammation in ulcerative colitis.

These medications can be given in two ways: subcutaneously (injection under the skin) or intravenously (infusion into a vein).

The specific medication, dosage, frequency, and method of administration will be determined by the study protocol for your assigned group.

If you are in Part A and taking corticosteroids, you will maintain the same dose throughout the 12-week treatment period.

If you are in Part B and taking corticosteroids, you will maintain the same dose through Week 6, then begin gradually reducing the dose starting at Week 6.

4 Assessments at Week 12

At Week 12, your condition will be evaluated to measure the effectiveness of the treatment.

If you are in Part A, the main assessment will focus on changes in histologic disease activity (examination of tissue samples under a microscope to assess inflammation) compared to the beginning of the study.

If you are in Part B, the main assessment will determine whether you have achieved clinical remission (absence or minimal symptoms of the disease).

Additional assessments will include evaluation of intestinal lining appearance through endoscopy, symptom scores, and blood tests to measure drug levels and immune responses to the study medications.

5 Extended treatment period for Part B participants

If you are in Part B, the study may continue beyond Week 12 up to Week 48.

During this extended period, additional assessments will be conducted to evaluate long-term effectiveness, including clinical remission status at Week 48.

Continued monitoring of drug levels and immune responses will occur throughout this period.

Who Can Join the Study?

  • You must be 18 years of age or older
  • You must have been diagnosed with ulcerative colitis (a condition causing inflammation and sores in the lining of the large intestine) for at least 3 months before starting the study, confirmed by a procedure where a camera examines your intestine and tissue samples
  • Your ulcerative colitis must be active and affect an area of at least 15 centimeters from the anal opening, confirmed by the screening examination with a camera
  • Your disease must be moderately to severely active, measured by specific scores that assess your symptoms including bleeding and inflammation seen during examination
  • You must have a history of one of the following: being dependent on corticosteroids (medicines that reduce inflammation), not responding well to treatment, losing response to treatment over time, or not being able to tolerate at least one type of treatment, which includes either standard treatments like corticosteroids or immune-suppressing medicines, or advanced therapies like specific biological medicines or other specialized drugs
  • If you are taking oral corticosteroids (anti-inflammatory pills), you must have been on a stable dose for at least 2 weeks before starting the study and be willing to continue the same dose during the study period as specified for your group

Who Cannot Join the Study?

  • The study has not provided specific exclusion criteria information in the available data
  • You should discuss with the study doctor whether you are eligible to participate based on your individual health situation
  • General exclusion criteria typically exist for clinical trials but are not listed in the provided study information
  • The study doctor will review your complete medical history to determine if you can safely participate

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Centrul Medical Sfanta Vineri S.R.L. Bucharest Romania
Medizinische Universitaet Innsbruck Innsbruck Austria
Fondazione Policlinico Universitario Agostino Gemelli IRCCS Rome Italy
Zuyderland Medisch Centrum Stichting Geleen The Netherlands
Nemocnice Pardubickeho kraje a.s. Pardubice Czechia
Nemocnica AGEL Zvolen a.s. Zvolen Slovakia
Katholieke Universiteit te Leuven Leuven Belgium
DRK Kliniken Berlin Berlin Germany
Futuremeds Sp. z o.o. Wroclaw Poland
Oncopole Claudius Regaud Toulouse France
Gyncentrum Sp. z o.o. Katowice Poland
IRCCS Humanitas Research Hospital Rozzano Italy
Twoja Przychodnia Opolskie Centrum Medyczne Opole Poland

Other Sites

Site Name City Country Status
Fejer Varmegyei Szent Gyoergy Egyetemi Oktato Korhaz Szekesfehervar Hungary
Central Hospital Of Northern Pest Military Hospital Budapest Hungary
Azienda Ospedaliera di Padova Padua Italy
Endomed s.r.o. Kosice Slovakia
Hippokration Hospital Athens Greece
Evangelismos S.A. Athens Greece
Wsd Medi Clinical Sp. z o.o. Warsaw Poland
The medical centre Kanev Ltd. Ruse Bulgaria
Universitaetsklinikum Tuebingen AöR Tuebingen Germany
Ospedale San Raffaele S.r.l. Milan Italy
Fondazione IRCCS Policlinico San Matteo Pavia Italy
IRCCS Policlinico San Donato San Donato Milanese Italy
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Vilniaus universiteto ligonine Santaros klinikos VšĮ Vilnius Lithuania
Fakultni Nemocnice Brno Brno Czechia
Sint-Lucas General Hospital Brugge Belgium
Uniteversity Muliprofile Hospital For Active Treatment Tsaritsa Yoanna-Isul EAD Sofia Bulgaria
Fakultni Nemocnice U Sv Anny V Brne Brno-Stred Czechia
General University Hospital Of Patras Patras Greece
Hospital Universitario Lucus Augusti Lugo Spain
Vojenska Nemocnice Brno Brno-Zidenice Czechia
Specijalna Bolnica Medico Rijeka Croatia
Cliniq s.r.o. Bratislava Slovakia
H-T. Centrum Medyczne Sp. z o.o. Tychy Poland
Poliklinika Solmed d.o.o. Zagreb Croatia
Klaipedos universiteto ligonine VšĮ Klaipeda Lithuania
Spitalul De Oncologie Monza S.R.L. Bucharest Romania
Universitair Ziekenhuis Gent Gent Belgium
Universitaetsklinikum Schleswig-Holstein AöR Kiel Germany
Universitaetsklinikum Brandenburg an der Havel GmbH Brandenburg An Der Havel Germany
Hospital Universitario Puerta De Hierro De Majadahonda Majadahonda Spain
Hospital Universitario 12 De Octubre Madrid Spain
Algemeen Ziekenhuis Delta Roeselare Belgium
Krankenhaus Waldfriede e.V. Berlin Germany
Mtz Clinical Research Powered By Pratia Warsaw Poland
Twoja Przychodnia Szczecinskie Centrum Medyczne Sp. z o.o. Szczecin Poland
Delta Health Care S.R.L. Bucharest Romania
AZ Sint-Lucas & Volkskliniek Gent Belgium
Vitaz Sint-Niklaas Belgium
Hospital Universitario Infanta Leonor Madrid Spain
Gesundheit Nord gGmbH Klinikverbund Bremen Bremen Germany
University General Hospital Of Heraklion Heraklion Greece
National Institute Of Gastroenterology Saverio De Bellis Research Hospital Castellana Grotte Italy
Sonomed Sp. z o.o. Szczecin Poland
CCR Ostrava s.r.o. Moravska Ostrava A Privoz Czechia
Eb Group Sp. z o.o. Warsaw Poland
Nowe Zdrowie-Ck Kieltucki I Wspolnicy Sp. j. Staszow Poland
Centrum Medyczne Oporow Wroclaw Poland
Vita Longa Sp. z o.o. Katowice Poland
Centrum Medyczne Med-Gastr Sp. z o.o. Lodz Poland
Azienda Ospedaliera Ordine Mauriziano Di Torino Turin Italy
Acibadem City Clinic University Multiprofile Hospital For Active Treatment EOOD Sofia Bulgaria
National Multidisciplinary Transport Hospital Tsar Boris III Sofia Bulgaria
Azienda Socio Sanitaria Territoriale Ovest Milanese Legnano Italy
Endoskopia Sp. z o.o. Sopot Poland
SurGal Clinic s.r.o. Brno-Sever Czechia
Krankenhaus Der Barmherzigen Brueder Wien Vienna Austria
Multiprofile Hospital For Active Treatment St. Ivan Rilski Gorna Oriahovitsa EOOD Gorna Oryahovitsa Bulgaria
Poliklinika Borzan d.o.o. Osijek Croatia
Tvm Med Serv S.R.L. Cluj Napoca Romania
Gastro LM s.r.o. Presov Slovakia
KBC Zagreb Zagreb Croatia
Spitalul Clinic Colentina Bucuresti Bucharest Romania
Obudai Egeszseguegyi Centrum Kft. Dunaújváros Hungary
Virgen del Rocío University Hospital Sevilla Spain
Centrum Medyczne Medyk Sp. z o.o. Rzeszow Poland
Melita Medical sp. z o.o. Wroclaw Poland
Semmelweis University Budapest Hungary
Stichting Radboud University Medical Center Nijmegen The Netherlands
Centre Hospitalier Universitaire De Nice Nice France
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH Ulm Germany
Centre Hospitalier Lyon Sud Pierre Benite France
Bekes Varmegyei Koezponti Korhaz Gyula Hungary
Clinical Best Solutions Sp. z o.o. S.K. Lublin Poland
Dkc Fokus-5 Lzip OOD Sofia Bulgaria
IRCCS Ospedale Sacro Cuore Don Calabria Negrar di Valpolicella Italy
Universitaetsklinikum Leipzig AöR Leipzig Germany
Multiprofile Hospital For Active Treatment Vita Ltd. Sofia Bulgaria
Uniklinikum Salzburg Salzburg Austria
University General Hospital Attikon General Hospital Of West Attica H Agia Varvara Chaidari Greece
EMC Instytut Medyczny S.A. Poznan Poland
Asociatia Oncohelp Timisoara Romania
Gastro Jeka s.r.o. Klatovy Czechia
Medical Care Unit Dachau Dachau Germany
Gugud Btbpisj Kvgrkvcwe Sec z ofzi Klodzko Poland
Ggrgjpgbp Slgizm Constanta Romania
Moaynzo cyqvos Ogfsgf Lxxh Sofia Bulgaria
Azkuoklzx Ufn Amsterdam The Netherlands
Aoyesxzjjq Pltzdblx Haxmruxd Dd Malboskmp Marseille France
Smn Eavzzhtsi Hxnhwpqc Tgsgual Tilburg The Netherlands
Aabhthr Ojbspekzejc Ueqeaqypkxdrw Cuzgqvusssqi Dhnak Slwwxt E Dnfey Sfeqtfu Da Tlfbgs Turin Italy
Kzcxozse drf Uozgidytfamq Mimqtgxf Awr Munich Germany
Vkxkmiov &mllh Vpjyyyf Snz z oqip Wroclaw Poland
Lunzt Gwyvxoo Hjnnycdm Ok Afgwvu Athens Greece
Mdiiivut Sr z oeep Bydgoszcz Poland
Fncebfmj nimobtclb Mvwbm a Hzvipze Prague Czechia
Awromlp Uibuc Spsxidxog Lpukaf Dp Bvvwevp Bologna Italy
Oaoscli Bfrms Koasicnboaf Csgevmaoi Safp Eci Gtbhxbhruzcfr Mtqpndlnju Tyyfswo Bydgoszcz Poland
Jexyrvgr Klzqtv Udocbfqpwo Linz Austria
Insjyoji Omactqakxsihuam Dv lhcwhmyoxkyqf Jjlmm Vliyf Nantes France
Irrmdyqi dz Cykfbmhglqhk Hqxlfbkeack Uhkgcyxkhjwxn dx Swrqf Ekaizzt (kbwiftb Saint Priest En Jarez France
Ijwmxrmx Uzi Kaunas Lithuania
Gdroba Ubmiqbwigx Fgwlkienv Frankfurt Germany
Wbd Wtjfpj Iaz Pqzdh Pwrftgqy Kiidmto Warsaw Poland

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Austria Austria
Recruiting
30.10.2025
Belgium Belgium
Recruiting
30.10.2025
Bulgaria Bulgaria
Recruiting
30.10.2025
Croatia Croatia
Recruiting
30.10.2025
Czechia Czechia
Recruiting
30.10.2025
France France
Recruiting
30.10.2025
Germany Germany
Recruiting
30.10.2025
Greece Greece
Recruiting
30.10.2025
Hungary Hungary
Recruiting
30.10.2025
Italy Italy
Recruiting
30.10.2025
Lithuania Lithuania
Recruiting
30.10.2025
Poland Poland
Recruiting
30.10.2025
Romania Romania
Recruiting
30.10.2025
Slovakia Slovakia
Recruiting
30.10.2025
Spain Spain
Recruiting
30.10.2025
The Netherlands The Netherlands
Not yet recruiting
30.10.2025

Trial locations

Investigated drugs:

Long-acting antibodies are medications designed to stay in your body for an extended period of time. These are special proteins that work by targeting specific parts of your immune system that may be causing inflammation in your intestines. In this trial, they are being tested alone or in different combinations to see if they can help reduce the symptoms and inflammation caused by ulcerative colitis.

Placebo is an inactive substance that looks like the real medication but contains no active treatment. It is used in clinical trials to compare against the actual medications being tested to help determine if the medications are truly effective.

Ulcerative Colitis – Ulcerative Colitis is a chronic inflammatory bowel disease that affects the lining of the large intestine and rectum. The condition causes long-lasting inflammation and sores called ulcers in the innermost lining of the colon. Symptoms typically include abdominal pain, diarrhea often with blood or pus, and urgent bowel movements. The disease usually develops gradually and can worsen over time if not managed properly. People with this condition often experience periods when symptoms flare up and other times when symptoms improve or disappear. The inflammation typically starts in the rectum and can spread continuously through the colon.

Trial ID:
2025-521242-26-00
Protocol code:
SPY123-201
NCT ID:
NCT07012395
Trial Phase:
Therapeutic exploratory (Phase II)

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