In short
Clinical trials investigating Hydroxychloroquine Sulfate are studying how well it works and how safe it is in different diseases. These trials include adults and other patient groups with conditions such as rheumatoid arthritis, Sjögren’s syndrome, sarcoidosis, pregnancy-related antibody disorders, kidney disease, cancer, and more.
Key points
- Clinical trials of Hydroxychloroquine Sulfate are studying many different diseases, not just one condition. The main areas include rheumatoid arthritis, Sjögren’s syndrome, sarcoidosis, pregnancy-related antibody disorders, kidney disease, mastocytosis, multiple sclerosis, and some cancers. The studies include Phase 2, Phase 3, Phase 4, and Low Intervention designs, so they range from early testing to larger comparison trials. Some trials test Hydroxychloroquine Sulfate alone, while others test it with other medicines or against placebo. The main endpoints include symptom control, remission, lung function, kidney function, pregnancy outcomes, imaging changes, and safety. Several studies are completed, while many are still authorised and ongoing.
Trial overview
The trial data show that Hydroxychloroquine Sulfate is being studied in many different clinical settings, including autoimmune disease, pregnancy-related conditions, kidney disease, mastocytosis, multiple sclerosis, and cancer.
Some studies test it alone versus placebo, while others study it as part of a combination treatment or compare it with standard care.
Conditions studied
The largest group of studies focus on rheumatoid arthritis, including trials in early disease, active disease, and disease that has not improved enough with earlier treatment.
Other autoimmune and inflammatory conditions include primary Sjögren’s syndrome, extra pulmonary sarcoidosis, systemic sclerosis, idiopathic inflammatory myopathy, calcium pyrophosphate deposition disease, mastocytosis, and IgA nephropathy.
The trial set also includes studies in multiple sclerosis, antiphospholipid antibodies, recurrent pregnancy loss, metastatic refractory pancreatic cancer, and resectable head and neck or non-small cell lung cancer.
Study designs and phases
The studies include Phase 2, Phase 3, Phase 4, and Low Intervention designs.
Phase 2 trials in this set are used to explore early benefit and biological effects, such as changes in brain imaging, inflammation, or pregnancy outcomes.
Phase 3 trials are larger and often compare Hydroxychloroquine Sulfate with placebo or with other treatment strategies, such as steroid-sparing treatment in sarcoidosis or add-on treatment in systemic sclerosis.
The Low Intervention study in rheumatoid arthritis compares treatment strategies and looks at disease activity and use of advanced medicines over time.
What the trials measure
The main primary outcomes include symptom improvement, remission, and changes in disease activity scores.
Some trials measure lung function using forced vital capacity, which is a test of how much air a person can breathe out after a deep breath.
Other trials measure kidney function with GFR slope, which means the change in glomerular filtration rate over time and shows how well the kidneys are working.
Several studies use imaging or tissue tests, such as TSPO-PET in multiple sclerosis, immunohistochemical markers in cancer, and CD68 scoring in calcium pyrophosphate deposition disease.
Pregnancy studies measure outcomes such as pregnancy loss, preterm birth, and live birth rate.
Safety is also a major focus in some trials, including monitoring adverse events, vital signs, ECG results, and laboratory tests.
Who is being studied
Most trials enroll adults, and several focus on people with active disease, meaning the condition is currently causing symptoms or test changes.
Some studies are limited to people with biopsy-proven disease, such as IgA nephropathy, or to people with specific pregnancy-related antibody findings, such as antiphospholipid antibodies.
Other trials focus on patients who have not responded well to previous therapy, such as rheumatoid arthritis after methotrexate or leflunomide, or metastatic refractory pancreatic cancer.
Trial status and size
In the provided data, most studies are listed as Authorised, and a smaller number are marked Completed.
Enrollment ranges from small proof-of-concept studies with 20 to 34 participants to larger trials with more than 700 participants.
This wide range shows that Hydroxychloroquine Sulfate is being tested both in small early studies and in larger studies meant to compare treatment choices more fully.