A study testing SPY072 compared to placebo in adults with moderately to severely active rheumatologic disease

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What is this study about?

This study is looking at three types of rheumatologic disease that cause joint pain and swelling. The first type is rheumatoid arthritis, which is a condition where the body’s immune system attacks the joints, causing pain, swelling, and stiffness. The second type is axial spondyloarthritis, which is a disease that mainly affects the spine and can cause back pain and stiffness. The third type is psoriatic arthritis, which is a form of arthritis that affects some people who have psoriasis, a skin condition that causes red, scaly patches. All three conditions being studied are described as moderately to severely active, meaning they are causing significant symptoms. The study will test a medication called SPY072, which is given as an injection under the skin. Some participants will receive SPY072 while others will receive placebo.

The purpose of this study is to see if SPY072 can reduce disease activity in people with these three types of rheumatologic disease and to check if the medication is safe. The study will measure how well SPY072 works by looking at different aspects of disease activity. For rheumatoid arthritis, the study will check changes in disease activity at week 12. For axial spondyloarthritis and psoriatic arthritis, measurements will be taken at week 16. The study will also look at how many participants show improvement in their symptoms and will measure the levels of the medication in the blood.

During the study, participants will receive treatment for up to 40 weeks. The study will monitor participants for any unwanted effects or problems that might occur with the medication. The study will also check if the body develops any immune response to the medication. Different measurements will be used depending on which type of rheumatologic disease the participant has, but all are designed to see if the medication helps reduce joint pain, swelling, and other symptoms of the disease.

1 Initial treatment period begins

On the first day of the study, your participation officially begins. You will be assigned to receive either SPY072 or placebo. The placebo is an inactive substance that looks like the actual medication but contains no active ingredient.

The study medication will be administered as a subcutaneous injection, which means the injection is given under the skin.

The duration of your initial treatment period depends on which condition you have. If you have rheumatoid arthritis, this period will last 12 weeks. If you have axial spondyloarthritis or psoriatic arthritis, this period will last 16 weeks.

2 Regular monitoring and assessments

Throughout the treatment period, your condition will be regularly assessed using specific measurements.

If you have rheumatoid arthritis, your disease activity will be measured using a score called DAS28-CRP, which evaluates the number of swollen and tender joints along with inflammation levels in your blood.

If you have axial spondyloarthritis, your disease activity will be measured using a score called ASDAS, which assesses your symptoms and inflammation.

If you have psoriatic arthritis, your response will be measured using ACR20, which evaluates improvement in joint tenderness, joint swelling, and other disease measures.

Blood samples will be collected to measure the concentration of the study medication in your body and to check for any antibodies your body may develop against the medication.

3 Primary evaluation point

At week 12 for rheumatoid arthritis or week 16 for axial spondyloarthritis and psoriatic arthritis, the main evaluation of the treatment’s effectiveness will take place.

Your disease activity will be compared to your condition at the beginning of the study to determine if there has been improvement.

Safety monitoring will continue throughout this period, including assessment of any side effects or adverse events you may experience.

4 Continued follow-up period

After the primary evaluation point, you will continue to be monitored until the end of the study.

Safety assessments will continue to track any treatment-emergent adverse events, serious adverse events, adverse events of special interest, and any adverse events that might lead to stopping the study medication.

The total study duration is expected to continue until March 2028, though your individual participation length may vary.

Who Can Join the Study?

You must have a confirmed diagnosis of one of the following conditions: rheumatoid arthritis (a condition where the immune system attacks the joints causing pain and swelling), axial spondyloarthritis (inflammation of the spine and joints), or psoriatic arthritis (joint inflammation that occurs in people with the skin condition psoriasis) for at least 6 months before joining the study
For rheumatoid arthritis: You must have at least 4 swollen joints and at least 4 tender joints based on an examination of 28 joints
For axial spondyloarthritis: You must have a disease activity score of 4 or higher and back pain rated 4 or higher, and your symptoms must have started before age 45
For psoriatic arthritis: You must have at least 3 tender joints out of 68 examined and at least 3 swollen joints out of 66 examined
You must have a blood test showing high-sensitivity C-reactive protein (a marker of inflammation in the body) levels above the normal range
For rheumatoid arthritis: You must have either positive blood test results for rheumatoid factor or anti-citrullinated peptide antibodies (proteins in the blood that indicate rheumatoid arthritis), or previous x-rays showing bone damage in your hands or feet consistent with rheumatoid arthritis
For axial spondyloarthritis: You must have had an inadequate response or could not tolerate previous treatments with anti-inflammatory medications or certain biologic drugs
For psoriatic arthritis: You must have at least one visible psoriasis skin lesion or a documented history of psoriasis, and you must test negative for rheumatoid factor
You can be male or female
You must be an adult or elderly person

Who Cannot Join the Study?

The study information provided does not contain specific exclusion criteria, which are reasons why a patient cannot participate in the clinical trial
Without detailed exclusion criteria listed in the study documents, it is not possible to provide specific reasons that would prevent participation
Typically, exclusion criteria may include things like other medical conditions, certain medications being taken, pregnancy status for women who can become pregnant, or recent participation in other studies, but these specific details are not available in the provided information
The trial is studying a treatment called SPY072 for different types of joint and spine conditions that cause inflammation and pain
The study includes adults and elderly people of both male and female gender

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Futuremeds Sp. z o.o.	Wroclaw	Poland

Other Sites

Site Name	City	Country
Pratia Prague s.r.o.	Prague	Czechia
Centrum Medyczne Plejady Magdalena Celinska Loewenhoff Michal Zolnowski sp.k.	Cracow	Poland
Twoja Przychodnia Nowosolskie Centrum Medyczne Sp. z o.o.	Nowa Sol	Poland
CCR Ostrava s.r.o.	Moravska Ostrava A Privoz	Czechia
L.K.N. Arthrocentrum s.r.o.	Hlucin	Czechia
Medical Plus s.r.o.	Uherske Hradiste	Czechia
Etg Neuroscience Sp. z o.o.	Warsaw	Poland
Pratia Pardubice a.s.	Pardubice	Czechia
MUDr. Zuzana Stejfova – Revmatologicka ambulance	Prague	Czechia
Medical Center Medconsult Pleven OOD	Lovech	Bulgaria
Centrum Kliniczno-Badawcze J.Brzezicki B.Gornikiewicz-Brzezicka Lekarze sp.p.	Elblag	Poland
Mpkzoerah Ildtesrnjb Cnyjqney Stflxljr Sau z oagm	Warsaw	Poland
Hyejkenn Ubhizueftfphi Mzgjweb Dm Vdrhhkthyh	Santander	Spain
Oenzqjhifa Cyrpca Fos Ioxtyxwvmx Pmkivaus Fbz Seszkcbhdup Mfggpig Azhbjtfyfb Im Rbafehhsrrvs Dmh Gilbtxw Rfcndmen Atqawynw Eyej	Plovdiv	Bulgaria
Mrwfdda Cetwwb Mpdzbekbfk Pzojog Ost	Pleven	Bulgaria
Hhszhjrv Uhnalpslsscve dn A Cxidwr	A Coruna Galicia	Spain
Drhbfepsve Ctrqnajzeqqo Cdrovi Etwrzk Opc	Varna	Bulgaria

Trial status

Country	Status	Recruitment Start
Bulgaria	Not recruiting	17.12.2025
Czechia	Not recruiting	17.12.2025
Poland	Not recruiting	17.12.2025
Spain	Not recruiting	17.12.2025

Trial locations

SPY072 is an investigational medication being studied for the treatment of rheumatologic diseases. In this trial, it is being tested in adults with moderately to severely active rheumatoid arthritis, axial spondyloarthritis, and psoriatic arthritis. The medication is being evaluated to see if it can reduce disease activity and symptoms in these inflammatory joint conditions.

Placebo is an inactive substance that looks like the study medication but contains no active ingredients. It is used as a comparison to help researchers determine if SPY072 is actually working to improve the condition.

Investigated diseases:

Rheumatoid Arthritis – Rheumatoid arthritis is a long-term condition where the body’s immune system mistakenly attacks the joints, causing inflammation. The disease typically affects the small joints in the hands and feet first, but can spread to other joints throughout the body. Over time, the inflammation can damage the cartilage and bone within the joints, leading to pain, swelling, and stiffness. The joints may become deformed and lose their normal shape and alignment as the disease progresses. Symptoms often appear gradually and may come and go in periods of increased activity called flares. The condition can also affect other parts of the body beyond the joints, including the skin, eyes, lungs, and blood vessels.

Axial Spondyloarthritis – Axial spondyloarthritis is a chronic inflammatory disease that primarily affects the spine and the joints where the spine connects to the pelvis. The inflammation causes pain and stiffness in the lower back, buttocks, and sometimes the neck. Over time, the ongoing inflammation can lead to new bone formation in the spine, causing the vertebrae to fuse together. This fusion reduces flexibility and can result in a hunched posture. The disease usually begins in early adulthood and develops gradually over months or years. Some people may also experience inflammation in other joints, eyes, or the digestive system.

Psoriatic Arthritis – Psoriatic arthritis is an inflammatory joint condition that occurs in some people who have psoriasis, a skin disease characterized by red, scaly patches. The arthritis can affect any joint in the body, including the fingers, toes, knees, ankles, and spine. Joint pain, swelling, and stiffness are the main features, and these symptoms may appear on one or both sides of the body. The condition can also cause inflammation where tendons and ligaments attach to bones, particularly in the heels and feet. Over time, the inflammation may lead to joint damage and reduced mobility. The severity of joint symptoms does not always match the severity of skin symptoms.

Trial ID:

2025-521791-63-00

Protocol code:

SPY002-072-201

Trial Phase:

Therapeutic exploratory (Phase II)

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A study testing SPY072 compared to placebo in adults with moderately to severely active rheumatologic disease

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?