A Phase 2 interventional study of SP-420 in Beta Thalassemia Major Anemia and Myelodysplastic Syndrome, sponsored by Pharmacosmos A/S. Recruiting at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-24.
Sponsored by Pharmacosmos A/S · Phase 2, Interventional, and Treatment
Among 31 studies in Myelodysplastic Syndromes with a site in Denmark — 6 open to participants now, 10 under way, 1 of them phase 3. Myelodysplastic Syndromes · Denmark.
Among the 31 studies in Myelodysplastic Syndromes with a site in Denmark, this one is the 16th largest by planned enrollment of the 24 interventional ones that give a count, is one of 3 that started in 2023, is one of 7 in phase 2, and was the 28th registered.
1,997 studies on the registry are indexed under Myelodysplastic Syndromes; 324 are open to participants now.
This study's planned enrollment of 90 is above the median of 40 across 1,611 interventional studies indexed under Myelodysplastic Syndromes.
Browse Myelodysplastic Syndromes studies →6 of the 31 studies in Myelodysplastic Syndromes with a site in Denmark are open now.
A study can be open while its sites in Denmark have not opened yet or have stopped. Only those recruiting at a site in Denmark →
Of the 262 Myelodysplastic Syndromes studies recruiting now, 165 (63%) set no upper age limit and 70 (27%) stop at 75 or younger; 57 take children under 18; 17 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →31 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 4 · Phase 2 10 · Phase 3 9
First in 1999; this study’s year is marked. 3 started in 2023.
Median enrollment 147 across the 24 interventional studies, 144 across the 7 observational. Of the 17 that completed or were terminated, 6 (35%) have results posted.
15 of 31 have an industry lead sponsor. The 10 most frequent:
Pharmacosmos A/S is the lead sponsor of 36 studies on the registry; 5 are open to participants now.
Pharmacosmos A/S has 1 study filed under Myelodysplastic Syndromes — fewer than ten, so there is no comparison to draw.
2 of the studies in Myelodysplastic Syndromes with a site in Denmark that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06773871Rigshospitalet, DenmarkFeasibility and Safety of Exercise in Patients With Low-risk Myeloid Cancers and Precursor Conditions | 2027-01 |
| NCT05693909Pharmacosmos A/SA Trial Testing SP-420 in Subjects With Transfusion-dependent β-thalassemia or Low-risk Myelodysplastic Syndromes | 2027-10 |
Among the 31 studies in Myelodysplastic Syndromes with a site in Denmark, from their registry updates:
Nothing recorded among them since 2026-09-25.
The goal of this clinical trial is to learn about SP-420 ability to remove iron from organs in subjects with transfusion-dependent β-thalassemia or transfusion-dependent low-risk myelodysplastic syndrome.
The main questions it aims to answer are:
Participants will:
Thalassemia cohorts:
Inclusion criteria:
Exclusion criteria:
Myelodysplastic Syndromes Cohorts:
Inclusion criteria:
Exclusion criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
SP-420 for 48 weeks
Drug: SP-420
SP-420 for 48 weeks
Drug: SP-420
SP-420 for 48 weeks
Drug: SP-420
SP-420 for 48 weeks
Drug: SP-420
SP-420 for 48 weeks
Drug: SP-420
SP-420 for 48 weeks
Drug: SP-420
Capsules for oral intake
To establish dose-response relationship of SP-420 for 24 weeks in the treatment of subjects with transfusion-dependent β-thalassemia
Time frame: 24 weeks
To assess the safety and tolerability of ascending doses of SP-420 after 12 weeks treatment of subjects with transfusion-dependent low-risk myelodysplastic syndrome
Time frame: 12 weeks
To assess the efficacy of SP-420 in clearing iron from the liver after 24 weeks treatment of subjects with transfusion-dependent β-thalassemia
Change in liver iron concentration (LIC) measured by R2-magnetic resonance imaging (MRI) from baseline to week 24
Time frame: 24 weeks
To assess the efficacy of SP-420 in clearing iron from the liver after 12 and 48 weeks treatment of subjects with transfusion-dependent β-thalassemia
Change in LIC measured by R2-MRI from baseline to week 12 and week 48
Time frame: 12 and 48 weeks
To assess the efficacy of SP-420 on serum (s-) ferritin
Change in s-ferritin from baseline to weeks 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48
Time frame: up to 48 weeks
To assess the safety and tolerability of ascending doses of SP-420
Type and incidence of adverse events (AEs)
Time frame: 48 weeks
Plan to share: No
No publications or documents are linked to this record.
Started Sep 2023 (actual). Primary completion is estimated for Oct 2027, 49 months after the start.
Of 52 industry-sponsored phase 2 interventional studies under Myelodysplastic Syndromes, half reached primary completion within 40 months of starting (the median), counting those still running; a quarter within 30 and three quarters within 62. This study's planned 49 months is above that.
Counting every sponsor, half of 279 studies reached it within 66 months; a quarter within 40 and three quarters within 104.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Studies of the drug tested here: SP-420